Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade

Herlev Hospital

Status and phase: Completed; Phase 4

Conditions: Neuromuscular Blockade

Treatments: Drug: rocuronium; Drug: placebo; Drug: sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT01933425

2013-001164-29 (EudraCT Number)

NMBDK2013

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

14 participants in 2 patient groups, including a placebo group

Deep neuromuscular block followed by no neuromuscular block

Active Comparator group

Description:

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

Treatment:

Drug: placebo

Drug: rocuronium

Drug: sugammadex

No neuromuscular block followed by deep neuromuscular block

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo

Drug: rocuronium

Drug: sugammadex