Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure

Herlev Hospital

Status and phase: Completed; Phase 4

Conditions: Laparoscopy; Pain; Neuromuscular Blockade

Treatments: Drug: placebo; Drug: Rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT01722097

NMBDK2012

2012-003787-51 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain. Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).

Primary hypothesis:

Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective laparoscopic hysterectomy (total/subtotal)
• 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
• Impaired liver function
• Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

Deep neuromuscular blockade

Active Comparator group

Description:

Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron

Treatment:

Drug: Rocuronium

Moderate neuromuscular blockade

Placebo Comparator group

Description:

Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron

Treatment:

Drug: placebo