Trial Outcomes & Findings for Impact of Propofol Reduction in Anesthesia Induction (NCT NCT04194151)

Results Overview

Non-invasive systolic blood pressure change (%) at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

192 participants

Primary outcome timeframe

Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

Results posted on

2020-08-12

Participant Flow

Every patient who agreed to participate and required general anesthesia with endotracheal intubation by the same anesthesiologist

Randomization was prior to data collection. The patient number was assigned by computerized randomizer to the 6 study groups. The collection was systematic from day one of the study, including all patients who met inclusion criteria and accepted participation. Of 192 patients enrolled, 186 met inclusion criteria.

Participant milestones

Participant milestones
Measure	2 Minute - 2 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol	2 Minute - 1,5 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol	2 Minutes - 1 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol	1 Minute - 2 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol	1 Minute - 1,5 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol	1 Minute - 1 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol
Overall Study STARTED	32	32	32	32	32	32
Overall Study COMPLETED	31	30	31	31	32	31
Overall Study NOT COMPLETED	1	2	1	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	2 Minute - 2 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol	2 Minute - 1,5 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol	2 Minutes - 1 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol	1 Minute - 2 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol	1 Minute - 1,5 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol	1 Minute - 1 mg/kg Group 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol
Overall Study Physician Decision	1	1	1	1	0	1
Overall Study Monitorization problem	0	1	0	0	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2 Minute - 2 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol	2 Minute - 1,5 mg/kg Group n=30 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol	2 Minute - 1 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol	1 Minute - 2 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol	1 Minute - 1,5 mg/kg Group n=32 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol	1 Minute - 1 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol	Total n=186 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 20 • n=31 Participants	61 years STANDARD_DEVIATION 17 • n=30 Participants	60 years STANDARD_DEVIATION 19 • n=31 Participants	59 years STANDARD_DEVIATION 17 • n=31 Participants	64 years STANDARD_DEVIATION 18 • n=32 Participants	55 years STANDARD_DEVIATION 16 • n=31 Participants	60 years STANDARD_DEVIATION 18 • n=186 Participants
Sex: Female, Male Female	15 Participants n=31 Participants	14 Participants n=30 Participants	17 Participants n=31 Participants	17 Participants n=31 Participants	18 Participants n=32 Participants	14 Participants n=31 Participants	95 Participants n=186 Participants
Sex: Female, Male Male	16 Participants n=31 Participants	16 Participants n=30 Participants	14 Participants n=31 Participants	14 Participants n=31 Participants	14 Participants n=32 Participants	17 Participants n=31 Participants	91 Participants n=186 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
weight	73 kilograms STANDARD_DEVIATION 16 • n=31 Participants	77 kilograms STANDARD_DEVIATION 17 • n=30 Participants	70 kilograms STANDARD_DEVIATION 15 • n=31 Participants	71 kilograms STANDARD_DEVIATION 15 • n=31 Participants	71 kilograms STANDARD_DEVIATION 15 • n=32 Participants	73 kilograms STANDARD_DEVIATION 15 • n=31 Participants	72 kilograms STANDARD_DEVIATION 15 • n=186 Participants
anesthesia risk (ASA), categorical Low risk	20 Participants n=31 Participants	19 Participants n=30 Participants	17 Participants n=31 Participants	21 Participants n=31 Participants	13 Participants n=32 Participants	21 Participants n=31 Participants	111 Participants n=186 Participants
anesthesia risk (ASA), categorical High risk	11 Participants n=31 Participants	11 Participants n=30 Participants	14 Participants n=31 Participants	10 Participants n=31 Participants	19 Participants n=32 Participants	10 Participants n=31 Participants	75 Participants n=186 Participants
Hypertension	15 Participants n=31 Participants	9 Participants n=30 Participants	15 Participants n=31 Participants	13 Participants n=31 Participants	16 Participants n=32 Participants	13 Participants n=31 Participants	81 Participants n=186 Participants
Antihypertensive treatment	9 Participants n=31 Participants	9 Participants n=30 Participants	12 Participants n=31 Participants	10 Participants n=31 Participants	12 Participants n=32 Participants	11 Participants n=31 Participants	63 Participants n=186 Participants
Heart rate treatment	11 Participants n=31 Participants	7 Participants n=30 Participants	10 Participants n=31 Participants	9 Participants n=31 Participants	11 Participants n=32 Participants	3 Participants n=31 Participants	51 Participants n=186 Participants

PRIMARY outcome

Timeframe: Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

Non-invasive systolic blood pressure change (%) at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.

Outcome measures

Outcome measures
Measure	2 Minute - 2 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol	2 Minute - 1,5 mg/kg Group n=30 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol	2 Minute - 1 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol	1 Minute - 2 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol	1 Minute - 1,5 mg/kg Group n=32 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol	1 Minute - 1 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol
Systolic Blood Pressure Variation SBP baseline/pre-intubation	26 percentage of variation Standard Deviation 16	23 percentage of variation Standard Deviation 12	18 percentage of variation Standard Deviation 13	22 percentage of variation Standard Deviation 11	18 percentage of variation Standard Deviation 13	17 percentage of variation Standard Deviation 13
Systolic Blood Pressure Variation SBP baseline/postintubation	11 percentage of variation Standard Deviation 22	8 percentage of variation Standard Deviation 15	9 percentage of variation Standard Deviation 19	14 percentage of variation Standard Deviation 18	16 percentage of variation Standard Deviation 19	8 percentage of variation Standard Deviation 16
Systolic Blood Pressure Variation SBP pre-intubation/postintubation	-22 percentage of variation Standard Deviation 27	-21 percentage of variation Standard Deviation 28	-12 percentage of variation Standard Deviation 17	-12 percentage of variation Standard Deviation 21	-3 percentage of variation Standard Deviation 16	-12 percentage of variation Standard Deviation 16

PRIMARY outcome

Timeframe: Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

Heart rate change (%) registered at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in HR between the studied moments. Negative results mean percentage increase in HR between the studied moments.

Outcome measures

Outcome measures
Measure	2 Minute - 2 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol	2 Minute - 1,5 mg/kg Group n=30 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol	2 Minute - 1 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol	1 Minute - 2 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol	1 Minute - 1,5 mg/kg Group n=32 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol	1 Minute - 1 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol
Heart Rate Variation HR baseline/pre-intubation	6 percentage of variation Standard Deviation 13	4 percentage of variation Standard Deviation 8	4 percentage of variation Standard Deviation 10	1 percentage of variation Standard Deviation 11	4 percentage of variation Standard Deviation 15	5 percentage of variation Standard Deviation 14
Heart Rate Variation HR baseline/postintubation	-10 percentage of variation Standard Deviation 19	-8 percentage of variation Standard Deviation 15	-9 percentage of variation Standard Deviation 16	-4 percentage of variation Standard Deviation 17	-5 percentage of variation Standard Deviation 20	-10 percentage of variation Standard Deviation 18
Heart Rate Variation HR pre-intubation/postintubation	-17 percentage of variation Standard Deviation 19	-12 percentage of variation Standard Deviation 16	-15 percentage of variation Standard Deviation 20	-5 percentage of variation Standard Deviation 16	-10 percentage of variation Standard Deviation 19	-17 percentage of variation Standard Deviation 19

PRIMARY outcome

Timeframe: Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

Non-invasive SBP change (%) in patients \> 55 years at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.

Outcome measures

Outcome measures
Measure	2 Minute - 2 mg/kg Group n=18 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol	2 Minute - 1,5 mg/kg Group n=23 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol	2 Minute - 1 mg/kg Group n=18 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol	1 Minute - 2 mg/kg Group n=16 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol	1 Minute - 1,5 mg/kg Group n=21 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol	1 Minute - 1 mg/kg Group n=13 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol
Systolic Blood Pressure Variation in Elderly (>55y) SBP baseline/pre-intubation	36 percentage of variation Standard Deviation 12	26 percentage of variation Standard Deviation 12	21 percentage of variation Standard Deviation 13	29 percentage of variation Standard Deviation 6	21 percentage of variation Standard Deviation 13	22 percentage of variation Standard Deviation 13
Systolic Blood Pressure Variation in Elderly (>55y) SBP baseline/postintubation	19 percentage of variation Standard Deviation 22	10 percentage of variation Standard Deviation 14	13 percentage of variation Standard Deviation 19	22 percentage of variation Standard Deviation 15	22 percentage of variation Standard Deviation 17	12 percentage of variation Standard Deviation 13
Systolic Blood Pressure Variation in Elderly (>55y) SBP pre-intubation/postintubation	-27 percentage of variation Standard Deviation 32	-23 percentage of variation Standard Deviation 30	-10 percentage of variation Standard Deviation 16	-10 percentage of variation Standard Deviation 23	2 percentage of variation Standard Deviation 13	-15 percentage of variation Standard Deviation 19

SECONDARY outcome

Timeframe: After administration of propofol, time is measured in seconds until BIS values are less than 60

Bispectral index (BIS)\<60 meaning "general anesthesia", BIS\>60 meaning mild/moderate sedation. We measure the time until patient reachs hypnosis

Outcome measures

Outcome measures
Measure	2 Minute - 2 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol	2 Minute - 1,5 mg/kg Group n=30 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol	2 Minute - 1 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol	1 Minute - 2 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol	1 Minute - 1,5 mg/kg Group n=32 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol	1 Minute - 1 mg/kg Group n=31 Participants 2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol
Time to Hypnosis	54 seconds Standard Deviation 29	49 seconds Standard Deviation 27	62 seconds Standard Deviation 34	41 seconds Standard Deviation 20	47 seconds Standard Deviation 15	67 seconds Standard Deviation 42

SECONDARY outcome

Timeframe: 1 minute after intubation

Patients who suffered SPB reduction \> 30% or SPB \< 90mmHg, receive vasoactive drugs