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

Leiden University Medical Center109 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

109

Conditions

Surgical Conditions

Interventions

RocuroniumDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Leiden University Medical Center

Leiden, South Holland, Netherlands

Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek

The Hague, South Holland, Netherlands

Outcomes

Primary Outcomes

Surgical Rating

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.

Time frame: intraoperative

Secondary Outcomes

Extubation

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

Time frame: intraoperative

Pain

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.

Time frame: postoperative, for up to 2 hours

Respiration

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.

Time frame: 2 hours postoperative

Mean Arterial Blood Pressure

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.

Time frame: 2 hours postoperative

Data from ClinicalTrials.gov

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