The Laparotomy Study

Herlev Hospital

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Cancer

Treatments: Drug: Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).; Drug: Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.

Study type: Interventional

Funder types: Other

Identifiers

NCT02140593

Lap2014NMB

2014-001155-22 (EudraCT Number)

Details and patient eligibility

About

The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between optimal surgical conditions and the risk of postoperative residual blockade.

The aim of the study is to investigate if intense NMB improves surgical conditions during operation in patients scheduled for elective open upper abdominal surgery.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients > 18 years old
• Elective open upper abdominal surgery
• Can read and understand Danish
• Informed consent

Exclusion criteria

• Known allergy to rocuronium or sugammadex
• Severe renal disease, defined by S-creatinine> 0.200 mmol/L, GFR < 30ml/min or hemodialysis
• Neuromuscular disease that may interfere with neuromuscular data
• Abdominal mesh with size larger than 5*5 cm
• Lactating or pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups, including a placebo group

Standard neuromuscular blockade

Placebo Comparator group

Description:

Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).

Treatment:

Drug: Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).

Deep neuromuscular blockade

Active Comparator group

Description:

Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.

Treatment:

Drug: Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.