Trial Outcomes & Findings for The Laparotomy Study (NCT NCT02140593)

Results Overview

The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure. (Rated on a 5 point subjective rating scale; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

128 participants

Primary outcome timeframe

After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes

Results posted on

2017-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Neuromuscular Blockade Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo). Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).	Deep Neuromuscular Blockade Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment. Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Overall Study STARTED	63	65
Overall Study COMPLETED	63	65
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Laparotomy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Neuromuscular Blockade n=63 Participants Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo). Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).	Deep Neuromuscular Blockade n=65 Participants Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment. Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.	Total n=128 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 10 • n=5 Participants	63 years STANDARD_DEVIATION 11 • n=7 Participants	64 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	38 Participants n=7 Participants	72 Participants n=5 Participants
Body mass index	25 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants	26 kg/m^2 STANDARD_DEVIATION 5 • n=7 Participants	25 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants
Previous abdominal surgery	39 Participants n=5 Participants	46 Participants n=7 Participants	85 Participants n=5 Participants

PRIMARY outcome

Timeframe: After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes

The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure. (Rated on a 5 point subjective rating scale; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal)

Outcome measures

Outcome measures
Measure	Standard Neuromuscular Blockade n=63 Participants Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo). Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).	Deep Neuromuscular Blockade n=65 Participants Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment. Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Surgical Rating Score	4 units on a scale Interval 1.0 to 5.0	4.75 units on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: Immediatly after fascial closure

After last suture of fascial closure surgical conditions are rated on a 5 point scale

Outcome measures

Outcome measures
Measure	Standard Neuromuscular Blockade n=63 Participants Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo). Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).	Deep Neuromuscular Blockade n=65 Participants Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment. Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.
The Surgical Rating Score During Fascial Closure	4 units on a scale Interval 1.0 to 5.0	5 units on a scale Interval 3.0 to 5.0

Adverse Events

Standard Neuromuscular Blockade

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Deep Neuromuscular Blockade

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. Matias Vested Madsen

Herlev and Gentofte Hospital University of Copenhagen

Phone: +4538683868

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place