Trial Outcomes & Findings for Effect of Deep BLock on Intraoperative Surgical Conditions (NCT NCT01631149)

Results Overview

During the procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale. In order to reduce variability in the surgical rating all surgeries will be performed by one single surgeon. The rating scale will be a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 minute intervals. In case of a sudden change in surgical conditions additional scores will be added to the case record form. If conditions are poor (score 1 or 2), muscle relaxation will be increased, a score of 1 will be used. In each subject the scores over time were averaged and a comparison between treatments was performed using a t-test

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

Measurements will be made during the stay in the operating room for an average period of 3 hours

Results posted on

2016-10-17

Participant Flow

A total of 30 patients were recruited. In 4 one or more exclusion criteria were met, the others were randomized; 2 patients withdrew consent; two others replaced them.

No significant events occurred that delayed or interfered with the enrollment

Participant milestones

Participant milestones
Measure	Moderate/Normal Surgical Block A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.	Deep Surgical Block Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Deep BLock on Intraoperative Surgical Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moderate/Normal Surgical Block n=12 Participants A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.	Deep Surgical Block n=12 Participants Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.	Total n=24 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
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 12 • n=5 Participants	60 years STANDARD_DEVIATION 12 • n=7 Participants	60 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Netherlands	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Measurements will be made during the stay in the operating room for an average period of 3 hours

Population: Each participant that was dosed was analyzed

During the procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale. In order to reduce variability in the surgical rating all surgeries will be performed by one single surgeon. The rating scale will be a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 minute intervals. In case of a sudden change in surgical conditions additional scores will be added to the case record form. If conditions are poor (score 1 or 2), muscle relaxation will be increased, a score of 1 will be used. In each subject the scores over time were averaged and a comparison between treatments was performed using a t-test

Outcome measures

Outcome measures
Measure	Moderate/Normal Surgical Block n=12 Participants A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.	Deep Surgical Block n=12 Participants Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
Surgical Rating Scale	4 units on a scale (1-5) Standard Deviation 0.4	4.7 units on a scale (1-5) Standard Deviation 0.4

SECONDARY outcome

Timeframe: Measurements will be made during the stay in the recovery room for an average period of 3 hours

Population: In each subject the scores over time were averaged and a comparison between treatments was performed using a t-test

In the recovery room the respiratory rate will be measured continuously using the Respir8 respiratory rate monitor. The data will be recorded on the CRF at 15 min intervals. Breathing rate units are "number of breaths" as measured in 1 min. Comparison by t-test: NS between treatments

Outcome measures

Outcome measures
Measure	Moderate/Normal Surgical Block n=12 Participants A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.	Deep Surgical Block n=12 Participants Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
Breathing	14.5 breaths per min Standard Deviation 2.2	14.5 breaths per min Standard Deviation 2.2

SECONDARY outcome

Timeframe: measurements are made in the recovery room following surgery for an average prior of 1 hour

Population: The pain data were averaged over time and compared by t-test between groups

Using a 10 cm visual analogue score pain relief score will be measured. 0 = no pain 10 = most severe pain No statistical analysis was performed!

Outcome measures

Outcome measures
Measure	Moderate/Normal Surgical Block n=12 Participants A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.	Deep Surgical Block n=12 Participants Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
Post-operative Pain	2.6 units on a scale (0-10 cm) Standard Deviation 1.6	2.1 units on a scale (0-10 cm) Standard Deviation 2.2

SECONDARY outcome

Timeframe: Measurements will be made during the stay in the operating room for an average period of 3 hours

Using a 5-point sedation scale, sedation levels will be obtained throughout the postoperative period. 0 = wide awake 5= severely sedated, The sedation data were averaged over time.

Outcome measures

Outcome measures
Measure	Moderate/Normal Surgical Block n=12 Participants A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.	Deep Surgical Block n=12 Participants Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
Postoperative Sedation Score	2.0 units on a scale (0-5) Standard Error 0.6	1.3 units on a scale (0-5) Standard Error 1.0

SECONDARY outcome

Timeframe: Measurements will be made during the stay in the operating room for an average period of 3 hours

Using a yes - no questionnaire, the patients will be asked whether they are nauseated or not or whether they vomited. In fact yes indicates the nr of participants. No statistical analysis was performed.

Outcome measures

Outcome measures
Measure	Moderate/Normal Surgical Block n=12 Participants A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.	Deep Surgical Block n=12 Participants Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
Nausea and Vomiting	0 participants	0 participants

Adverse Events

Moderate/Normal Surgical Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Deep Surgical Block

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

Dr. Albert Dahan

Leiden University Medical center

Phone: 3171 526 2301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place