Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade

Phase 4

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Drug: rocuronium; Drug: sugammadex; Drug: placebo

• Registration Number: NCT01933425
• Lead Sponsor: Herlev Hospital

Brief Summary

To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg.

Hypothesis:

Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-02
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-02-24
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-27
• Last Update Submitted: 2015-03-27
• Results First Posted: 2015-03-30
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

• patients > 18 years old
• elective laparoscopic operation
• can read and understand Danish
• informed consent

Exclusion Criteria

• BMI > 30 kg/cm2
• known allergy to medications that are included in the project,
• severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or hemodialysis),
• neuromuscular disease that may interfere with neuromuscular data,
• lactating or pregnant,
• impaired liver function,
• converting to laparotomy,
• perioperative use of neuromuscular blocking agents before randomization,
• pneumoperitoneum set to >12 mmHg on the insufflator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Deep neuromuscular block followed by no neuromuscular block	placebo	Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal. Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade
No neuromuscular block followed by deep neuromuscular block	placebo	No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg. Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.
No neuromuscular block followed by deep neuromuscular block	rocuronium	No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg. Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.
No neuromuscular block followed by deep neuromuscular block	sugammadex	No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg. Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.
Deep neuromuscular block followed by no neuromuscular block	rocuronium	Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal. Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade
Deep neuromuscular block followed by no neuromuscular block	sugammadex	Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal. Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade

Primary Outcome Measures

Name	Time	Method
Intraabdominal Distance (Centimeters)	1 hour	Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).

Secondary Outcome Measures

Name	Time	Method
Intraabdominal Distance (Centimeters)	1 hour	Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1).
Surgical Conditions During Suturing of the Abdominal Fascia	1 hour	Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)

Trial Locations

Locations (1)

Department of minimal invasive gynecology Aleris-Hamlet Private Hospital; 🇩🇰 Copenhagen, Søborg, Denmark