Trial Outcomes & Findings for Effects of Intravenous Lidocaine Associated With Magnesium Sulfate on the Cisatracurium-Induced Neuromuscular Block (NCT NCT02483611)

NCT ID: NCT02483611

Last Updated: 2016-01-15

Results Overview

The latency is computed as the elapsed time to reduce the response of T1 to 5% of the initial contraction force after the infusion of cisatracurium. This outcome meansure was presented in seconds.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 48 participants
• Primary outcome timeframe: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes
• Results posted on: 2016-01-15

Participant Flow

After approval by the Research Ethics Committee, 48 patients were selected for the study. Patients were invited to participate in the study during the pre-anesthetic evaluation, at which were told about the objectives, benefits and risks of research and those who agreed to participate signed the free consent form.

Participant milestones

Measure	Group M (Magnesium Sulfate) This group received Magnesium Sulfate (MS) 40 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h during the surgery.	Group ML (Magnesium Sulfate Plus Lidocaine) This group received Magnesium Sulfate (MS) 40 mg/kg plus lidocaine 3 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h plus lidocaine 3 mg/kg/h during the surgery.	Group C (Control Group - Isotonic Solution) This group received isotonic solution in a equivalent volume as a bolus over 5 minutes, followed by continuous intravenous infusion of isotonic solution during the surgery.
Overall Study STARTED	16	16	16
Overall Study COMPLETED	16	16	15
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	Group M (Magnesium Sulfate) This group received Magnesium Sulfate (MS) 40 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h during the surgery.	Group ML (Magnesium Sulfate Plus Lidocaine) This group received Magnesium Sulfate (MS) 40 mg/kg plus lidocaine 3 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h plus lidocaine 3 mg/kg/h during the surgery.	Group C (Control Group - Isotonic Solution) This group received isotonic solution in a equivalent volume as a bolus over 5 minutes, followed by continuous intravenous infusion of isotonic solution during the surgery.
Overall Study Protocol Violation	0	0	1

Baseline Characteristics

Effects of Intravenous Lidocaine Associated With Magnesium Sulfate on the Cisatracurium-Induced Neuromuscular Block

Baseline characteristics by cohort

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	47 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 Participants
Region of Enrollment Brazil	16 participants n=5 Participants	16 participants n=7 Participants	15 participants n=5 Participants	47 participants n=4 Participants

PRIMARY outcome

Timeframe: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

Population: The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value \< 0.05)

The latency is computed as the elapsed time to reduce the response of T1 to 5% of the initial contraction force after the infusion of cisatracurium.

This outcome meansure was presented in seconds.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
Latency	139.70 seconds Standard Deviation 47.92	151.30 seconds Standard Deviation 47.97	147.80 seconds Standard Deviation 29.75

PRIMARY outcome

Timeframe: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

Population: The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by Kruskal-Wallis test. When differences were found between the groups, we used the Dunn test for multiple comparisons (p value \< 0.05)

The clinical duration is the elapsed time for T1 recovery = 25% (Dur25%) of the original value of T1 after the infusion of cisatracurium.

This outcome meansure was presented in minutes.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
Clinical Duration	82.68 minutes Interval 76.83 to 91.19	86.33 minutes Interval 82.65 to 88.19	64.8 minutes Interval 57.05 to 70.23

PRIMARY outcome

Timeframe: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

Population: The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value \< 0.05)

The recovery index is the elapsed time between the T1 recovery =25% (Dur25%) and T1 =75% (Dur75%) after the infusion of cisatracurium.

This outcome meansure was presented in minutes.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
Recovery Index	20.08 minutes Standard Deviation 6.49	20.26 minutes Standard Deviation 7.69	14.53 minutes Standard Deviation 1.52

PRIMARY outcome

Timeframe: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

Population: The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value \< 0.05)

The final recovery index is the elapsed time between the T1 recovery = 25% (Dur25%) and T4 / T1 = 80% (TOF = 80%) after the infusion of cisatracurium.

This outcome measure was presented in minutes.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
Final Recovery Index	27.97 minutes Standard Deviation 6.77	33.81 minutes Standard Deviation 10.97	21.51 minutes Standard Deviation 3.28

PRIMARY outcome

Timeframe: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

Population: The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value \< 0.05)

The total duration is the elapsed time for T1 recovery of the response to reach 95% of the initial after the infusion of cisatracurium.

This outcome measure was presented in minutes.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
Total Duration (Dur95%)	113.20 minutes Standard Deviation 12.16	120.10 minutes Standard Deviation 18.20	88.19 minutes Standard Deviation 16.34

PRIMARY outcome

Timeframe: The participants were followed during the anesthetic - surgical procedure

Spontaneous recovery is the elapsed time for the recovery of the TOF (T4 / T1) response to 90% of the original after infusion of cisatracurium.

This outcome measure was presented in minutes.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
Spontaneous Recovery (T4/T1=90%)	120.20 minutes Standard Deviation 10.88	126.70 minutes Standard Deviation 14.19	90.03 minutes Standard Deviation 12.78

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed when the patient arrived in the operating room

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M1 (Mean Arterial Pressure in the Moment 1)	94.63 mmHg Standard Deviation 10.18	88.75 mmHg Standard Deviation 10.05	100.10 mmHg Standard Deviation 16.62

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed immediately before induction of anesthesia

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M2 (Mean Arterial Pressure in the Moment 2)	87.63 mmHg Standard Deviation 12.10	84.69 mmHg Standard Deviation 11.38	92.47 mmHg Standard Deviation 12.30

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M3 (Mean Arterial Pressure in the Moment 3)	75.88 mmHg Standard Deviation 11.95	73.88 mmHg Standard Deviation 9.80	76.73 mmHg Standard Deviation 7.48

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed five minutes after M3 (in the end of the X and Y solutions infusion)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the end of the study solutions infusion.This time point was named as moment '4'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M4 (Mean Arterial Pressure in the Moment 4)	69.00 mmHg Interval 60.5 to 73.0	63.00 mmHg Interval 60.5 to 72.0	74.00 mmHg Interval 64.0 to 79.0

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed immediately before the tracheal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M5 (Mean Arterial Pressure in the Moment 5)	62.50 mmHg Interval 60.0 to 77.5	61.50 mmHg Interval 57.5 to 64.25	67.00 mmHg Interval 62.0 to 74.0

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed one minute after the tracheal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M6 (Mean Arterial Pressure in the Moment 6)	64.50 mmHg Interval 60.25 to 71.75	64.00 mmHg Interval 60.25 to 67.75	69.00 mmHg Interval 62.0 to 81.0

SECONDARY outcome

Timeframe: This measure of heart rate was performed when the patient arrived in the operating room

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The measure of heart rate was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M1 (Heart Rate in the Moment 1)	79.94 beats/min Standard Deviation 15.79	77.25 beats/min Standard Deviation 12.13	73.66 beats/min Standard Deviation 11.82

SECONDARY outcome

Timeframe: This measure of heart rate was performed immediately before induction of anesthesia

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M2 (Heart Rate in the Moment 2)	74.69 beats/min Standard Deviation 11.76	73.69 beats/min Standard Deviation 11.18	75.40 beats/min Standard Deviation 11.54

SECONDARY outcome

Timeframe: This measure of heart rate was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M3 (Heart Rate in the Moment 3)	72.94 beats/min Standard Deviation 10.96	74.19 beats/min Standard Deviation 8.65	75.40 beats/min Standard Deviation 11.54

SECONDARY outcome

Timeframe: This measure of heart rate was performed five minutes after M3 (in the end of the X and Y solutions infusion)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the end of the study solutions infusion. This time point was named as moment '4'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M4 (Heart Rate in the Moment 4)	71.94 beats/min Standard Deviation 10.87	72.25 beats/min Standard Deviation 9.78	65.07 beats/min Standard Deviation 10.01

SECONDARY outcome

Timeframe: This measure of heart rate was performed immediately before the tracheal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M5 (Heart Rate in the Moment 5)	67.56 beats/min Standard Deviation 10.05	69.31 beats/min Standard Deviation 7.73	64.27 beats/min Standard Deviation 10.81

SECONDARY outcome

Timeframe: This measure of heart rate was performed one minute after the tracheal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M6 (Heart Rate in the Moment 6)	66.50 beats/min Standard Deviation 10.11	68.19 beats/min Standard Deviation 8.40	65.13 beats/min Standard Deviation 10.50

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed 15 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 15 minutes after the traqueal intubation. This time point was named as moment '7a'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M7a (Mean Arterial Pressure in the Moment 7a)	66.00 mmHg Interval 60.75 to 73.0	61.50 mmHg Interval 60.0 to 67.75	69.00 mmHg Interval 63.0 to 79.0

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed 30 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M7b (Mean Arterial Pressure in the Moment 7b)	66.50 mmHg Interval 64.25 to 74.0	63.50 mmHg Interval 57.5 to 72.0	68.00 mmHg Interval 62.0 to 77.0

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed 45 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M7c (Mean Arterial Pressure in the Moment 7c)	69.25 mmHg Standard Deviation 6.74	63.00 mmHg Standard Deviation 7.62	69.00 mmHg Standard Deviation 7.56

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed 60 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M7d (Mean Arterial Pressure in the Moment 7d)	68.00 mmHg Interval 66.0 to 78.0	62.00 mmHg Interval 58.25 to 69.5	66.00 mmHg Interval 63.0 to 71.0

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed 75 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M7e (Mean Arterial Pressure in the Moment 7e)	68.00 mmHg Interval 61.25 to 76.5	66.00 mmHg Interval 59.0 to 69.75	69.00 mmHg Interval 65.0 to 73.0

SECONDARY outcome

Timeframe: This measure of average blood pressure was performed 90 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
MAP - M7f (Mean Arterial Pressure in the Moment 7f)	64.00 mmHg Interval 62.0 to 77.0	64.50 mmHg Interval 60.0 to 70.0	72.00 mmHg Interval 68.0 to 80.0

SECONDARY outcome

Timeframe: This measure of heart rate was performed 15 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 15 minutes after the traqueal intubation.This time point was named as moment '7a'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M7a (Heart Rate in the Moment 7a)	68.94 beats/min Standard Deviation 11.99	68.19 beats/min Standard Deviation 7.73	67.13 beats/min Standard Deviation 8.85

SECONDARY outcome

Timeframe: This measure of heart rate was performed 30 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M7b (Heart Rate in the Moment 7b)	67.44 beats/min Standard Deviation 10.95	68.38 beats/min Standard Deviation 9.28	64.00 beats/min Standard Deviation 8.23

SECONDARY outcome

Timeframe: This measure of heart rate was performed 45 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M7c (Heart Rate in the Moment 7c)	65.75 beats/min Standard Deviation 11.52	65.75 beats/min Standard Deviation 10.19	62.33 beats/min Standard Deviation 9.26

SECONDARY outcome

Timeframe: This measure of heart rate was performed 60 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M7d (Heart Rate in the Moment 7d)	66.19 beats/min Standard Deviation 12.82	65.31 beats/min Standard Deviation 10.87	61.93 beats/min Standard Deviation 9.00

SECONDARY outcome

Timeframe: This measure of heart rate was performed 75 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M7e (Heart Rate in the Moment 7e)	66.50 beats/min Interval 54.0 to 71.75	63.00 beats/min Interval 56.0 to 72.75	58.00 beats/min Interval 54.0 to 65.0

SECONDARY outcome

Timeframe: This measure of heart rate was performed 90 minutes after the traqueal intubation

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.

Outcome measures

Measure	Group M n=16 Participants Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery Magnesium Sulfate	Group ML n=16 Participants Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery Magnesium Sulfate Lidocaine	Group C n=15 Participants Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups Isotonic Solution
HR - M7f (Heart Rate in the Moment 7f)	66.00 beats/min Interval 53.5 to 70.0	61.00 beats/min Interval 55.0 to 64.0	61.00 beats/min Interval 55.75 to 73.75

Adverse Events

Group M

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group ML

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dra Waynice Neiva de Paula Garcia

University of Sao Paulo

Phone: 551636021000

Email: waynicegarcia@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place