The Laparotomy Study

Herlev Hospital128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

128

Conditions

Gastrointestinal Cancer

Interventions

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.DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Aarhus University Hospital Nørrebrogade

Aarhus, Denmark

Outcomes

Primary Outcomes

Surgical Rating Score

The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure. (Rated on a 5 point subjective rating scale; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal)

Time frame: After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes

Secondary Outcomes

The Surgical Rating Score During Fascial Closure

After last suture of fascial closure surgical conditions are rated on a 5 point scale

Time frame: Immediatly after fascial closure

Data from ClinicalTrials.gov

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