Pharmacodynamic Trial on Rocuronium in Obese Patients

Phase 4

Completed

• Conditions: Bariatric Surgery
• Interventions: Drug: Rocuronium

• Registration Number: NCT00540085
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Aim: To optimize the use of rocuronium (a neuromuscular blocking agent) in obese patients undergoing gastric bypass or gastric banding.

Background: During general anaesthesia, a neuromuscular blocking agent is needed to allow surgery and airway management. Optimal dosing is important in order to avoid inadequately muscle relaxation, but also to avoid overdosage, which can result in prolonged anaesthesia and respiratory complications.

Main hypothesis: Rocuronium dosed according to ideal body weight results in shorter duration of action compared to rocuronium dosed according to corrected body weight without prolonged onset time or compromised airway management or surgical demands for muscle relaxation.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-04
• Study First Posted: 2007-10-05
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-15
• Last Update Posted: 2009-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Age 18-65 years.
• Elective laparoscopic gastric banding or gastric bypass.

Exclusion Criteria

• Expected difficult endotracheal intubation based on anatomic or pathologic findings or history.
• Known or suspected neuromuscular disease, known to affect the neuromuscular blockade.
• Severely impaired renal or hepatic function, as evaluated by the investigator.
• Known or suspected allergy to drugs used in the trial.
• Daily or expected use during the trial of the following drugs, known to affect neuromuscular transmission: Inhalational anaesthetics, magnesiumsalts, clindamycin, polymyxins and aminoglycosides (gentamicin, neomycin, netilmicin, streptomycin og tobramycin).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Rocuronium	Rocuronium dosed after ideal body weight
B	Rocuronium	Rocuronium dosed after corrected body weight 20%
C	Rocuronium	Rocuronium dosed after corrected body weight 40%

Primary Outcome Measures

Name	Time	Method
Duration of action, defined as: Time to reappearance of T4.	1 day

Secondary Outcome Measures

Name	Time	Method
Complete duration of action, defined as: Time to TOF-ratio = 0.9	1 day
Onset time	1 day

Trial Locations

Locations (1)

Department of anaesthesia, Privathospitalet Hamlet A/S; 🇩🇰 Copenhagen, Denmark