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OpenTrials
Completed

NCT Number: NCT02140593

The Laparotomy Study

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.

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital Nørrebrogade

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Surgical Rating Score

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

    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)

Secondary outcomes

  1. The Surgical Rating Score During Fascial Closure

    Time frame: Immediatly after fascial closure

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

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

Muscle Relaxation During Open Upper Abdominal Surgery - Can the Surgical Conditions be Optimized?

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 16, 2014
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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