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Completed

NCT Number: NCT02553629

Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients

This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.

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Key information

Conditions

Surgical Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Leiden University Medical Center, Leiden, South Holland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I-III
  • BMI > 34 kg/m2
  • Elective bariatric surgery.

Exclusion criteria

  • Known or suspected neuromuscular disorders impairing neuromuscular function
  • Allergies to muscle relaxants, anesthetics or narcotics
  • A(family) history of malignant hyperthermia
  • Women who are or may be pregnant or are currently breast feeding
  • Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h.

Treatment and study plan

Rocuronium

Drug

Primary outcomes

  1. Surgical Rating

    Time frame: intraoperative

    During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated.

    The rating scale will be averaged for each subject and the mean values will be reported.

Secondary outcomes

  1. Extubation

    Time frame: intraoperative

    The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation).

  2. Pain

    Time frame: postoperative, for up to 2 hours

    pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported.

  3. Respiration

    Time frame: 2 hours postoperative

    Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged.

    The data were averaged per subject and the mean of the mean data are reported.

  4. Mean Arterial Blood Pressure

    Time frame: 2 hours postoperative

    Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit.

    The data will be averaged per subject and the mean of the mean values are reported.

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Medical Center Haaglanden
  • Merck Sharp & Dohme LLC

Registry information

Official study title

Effect of Depth of Neuromuscular Block on Intraoperative Surgical Conditions as Determined by the Leiden Surgical Rating Scale in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

Acronym: BLISS3

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 17, 2015
Registry last updated
Feb 3, 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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