Laparoscopic gastric banding or gastric bypass in propofol/remifentanil anaesthesia MedDRA version: 9.1 Level: LLT Classification code 10061966 Term: Gastric bypass MedDRA version: 9.1 Level: LLT Classification code 10060785 Term: Gastric banding
Conditions
Interventions
Product Name: Rocuronium
Product Code: N/A
Pharmaceutical Form: Injection*
INN or Proposed INN: ROCURONIUM BROMIDE
CAS Number: 119302919
Sponsors
Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Countries
Denmark
Outcome results
None listed