Pharmacodynamic trial on rocuronium in obese patients

Conditions: aparoscopic gastric banding or gastric bypass in propofol/remifentanil anaesthesia
MedDRA version: 9.1Level: LLTClassification code 10061966Term: Gastric bypass
MedDRA version: 9.1Level: LLTClassification code 10060785Term: Gastric banding

Registration Number: EUCTR2007-003005-27-DK

Lead Sponsor: Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Expected difficult endotracheal intubation based on anatomic or pathologic findings or history.
Known or suspected neuromuscular disease, known to affect the neuromuscular blocade.
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 aminoglykosides (gentamicin, neomycin, netilmicin, streptomycin og tobramycin).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ;Primary end point(s): Duration of action, defined as time to reappearance of T4 (first time the fourth twitch is seen in three consecutive measurements). ;Main Objective: To optimize rocuronium dosing in obese patients undergoing gastric bypass or gastric banding.<br><br>Main hypothesis: Rocuronium dosed according to ideal body weight results in shorter duration of action compared to rocuronum dosed according to corrected body weight without prolonged onset time or compromised endotracheal intubation or surgical demands for muscle relaxation.

Secondary Outcome Measures