Creating better surgical conditions. Measuring the operating space in the abdomen with and without muscle relaxatio

Phase 1

Conditions: To investigate if deep neuromucular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg.
MedDRA version: 14.1Level: LLTClassification code 10023692Term: Laparoscopically assisted hysterectomySystem Organ Class: 100000004865
MedDRA version: 14.1Level: LLTClassification code 10023691Term: Laparoscopic sterilizationSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-001164-29-DK

Lead Sponsor: Department of anesthesiology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 20

Inclusion Criteria

Patients > 18 years old
Elective gynecologic laparoscopy
Can read and understand Danish
Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 NMBA before randomization
Pneumoperitoneum set to >12 mmHg on the insufflator

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: Evaluation of surgical conditions during closure of abdominal fascia on a 4 point rating scale.<br>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). <br>Incidence of incisional hernia 6 months after surgery in group A and B.<br>;Primary end point(s): 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). ;Timepoint(s) of evaluation of this end point: During operation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluation of surgical conditions during closure of abdominal fascia on a 4 point rating scale.<br>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). <br>Incidence of incisional hernia 6 months after surgery in group A and B.<br>;Timepoint(s) of evaluation of this end point: During operation and 6 months after operation