Phase 4 N=109 Randomized Triple-blind Treatment

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

Surgical Conditions

Bottom Line

View on ClinicalTrials.gov: NCT02553629 ↗

Enrolled (actual)

109

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Surgical Rating — 4.2; 4.8 units on a scale — p=0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Rocuronium (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Leiden University Medical Center
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Surgical Rating	4.2; 4.8	0.001 sig
SECONDARY Extubation	3; 3	>0.05
SECONDARY Pain	4.4; 3.9	0.04 sig
SECONDARY Respiration	12.7; 12.6	>0.05
SECONDARY Mean Arterial Blood Pressure	98; 101	>0.05

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02553629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.