Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade

Study Overview
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Brief Summary
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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.

Official Title
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Optimizing Surgical Conditions: Intraabdominal Distance During Gynecologic Laparoscopic Surgery With and Without Muscle Relaxation (The Measurement Study)

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Drug: rocuronium
* Drug: sugammadex
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Deep neuromuscular block followed by no neuromuscular block<br>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 | Drug: rocuronium<br> <br> Drug: sugammadex<br> <br> Drug: placebo<br> <br> |
| Placebo Comparator: No neuromuscular block followed by deep neuromuscular block<br>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. | Drug: rocuronium<br> <br> Drug: sugammadex<br> <br> Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraabdominal Distance (Centimeters) | 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). | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraabdominal Distance (Centimeters) | 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). | 1 hour | 
| Surgical Conditions During Suturing of the Abdominal Fascia | Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4) | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, surgical conditions