Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients (BLISS3)

Leiden University Medical Center (LUMC)

Status and phase: Completed; Phase 4

Conditions: Surgical Conditions

Treatments: Drug: Rocuronium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02553629

NL52829.058.15

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

109 participants in 2 patient groups

moderate neuromuscular block

Active Comparator group

Description:

rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches

Treatment:

Drug: Rocuronium

deep neuromuscular block

Experimental group

Description:

rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches

Treatment:

Drug: Rocuronium