Trial Outcomes & Findings for The Muscle Relaxation-study (NCT NCT01523886)

Results Overview

The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 ("optimal") = "optimal" surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

49 participants

Primary outcome timeframe

From surgical incision to last suture has been placed, an expected average of 30 minutes

Results posted on

2014-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Deep Neuromuscular Blockade Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h	Moderate Neuromuscular Blockade Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
Overall Study STARTED	25	24
Overall Study COMPLETED	25	23
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Deep Neuromuscular Blockade Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h	Moderate Neuromuscular Blockade Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
Overall Study surgery cancelled	0	1

Baseline Characteristics

The Muscle Relaxation-study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Deep Neuromuscular Blockade n=25 Participants Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h	Moderate Neuromuscular Blockade n=23 Participants Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion	Total n=48 Participants Total of all reporting groups
Age, Continuous	45 years n=5 Participants	48 years n=7 Participants	45 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Denmark	25 participants n=5 Participants	23 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: From surgical incision to last suture has been placed, an expected average of 30 minutes

The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 ("optimal") = "optimal" surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.

Outcome measures

Outcome measures
Measure	Deep Neuromuscular Blockade n=25 Participants Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h	Moderate Neuromuscular Blockade n=23 Participants Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less	28 percentage of patients	4 percentage of patients

SECONDARY outcome

Timeframe: From surgical incision to last suture has been placed, an expected average of 30 minutes.

The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From surgical incision to last suture has been placed, an expected average of 30 minutes.

The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During dissection of the gallbladder

The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Preoperatively to 7 days after surgery

Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At arrival to the postanesthesia care department, 2 hours and 1 day after surgery

Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from the day of surgery to re-establishing normal functional level - an expected average of 7 days.

Numer of days before re-establing normal functional level

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From surgical incision to last suture has been placed, an expected average of 30 minutes.

Number of procedures which can be done with pneumoperitoneum 8 mmHg

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From surgical incision to last suture has been placed.

Duration of surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From induction of anesthesia to patient ready to leave the operating theatre

Duration of anesthesia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The first 24 hours after surgery

Consumption of analgesics during the first 24 hours after surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The first 24 hours after surgery

The incidence of nausea and vomiting during the first 24 hours after surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the first 24 hours after surgery

Use of anti-emetics during the first 24 hours after surgery

Outcome measures

Outcome data not reported

Adverse Events

Deep Neuromuscular Blockade

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Moderate Neuromuscular Blockade

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Deep Neuromuscular Blockade n=25 participants at risk Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h	Moderate Neuromuscular Blockade n=23 participants at risk Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
Surgical and medical procedures Prolonged hospitalization	4.0% 1/25 • Number of events 1	4.3% 1/23 • Number of events 1
Surgical and medical procedures Readmission to hospital	8.0% 2/25 • Number of events 2	0.00% 0/23

Other adverse events

Other adverse events
Measure	Deep Neuromuscular Blockade n=25 participants at risk Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h	Moderate Neuromuscular Blockade n=23 participants at risk Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
Musculoskeletal and connective tissue disorders Pain	16.0% 4/25 • Number of events 4	4.3% 1/23 • Number of events 1
Surgical and medical procedures Pain	16.0% 4/25 • Number of events 4	26.1% 6/23 • Number of events 6
Surgical and medical procedures Headache and vertigo	12.0% 3/25 • Number of events 3	13.0% 3/23 • Number of events 3
Surgical and medical procedures Bleeding from sutur	0.00% 0/25	4.3% 1/23 • Number of events 1
Gastrointestinal disorders hoarseness	4.0% 1/25 • Number of events 1	0.00% 0/23

Additional Information

Mona R Gätke, MD, PH.D.

Herlev Hospital

Phone: 004538662420

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place