Pharmacodynamic Trial on Rocuronium in Obese Patients

Condition(s) targeted: Bariatric Surgery

Intervention: Rocuronium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Rigshospitalet, Denmark

Official(s) and/or principal investigator(s):
Lars S Rasmussen, MD, DMSc, Study Chair, Affiliation: Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Christian S Meyhoff, MD, PhD, Principal Investigator, Affiliation: Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Casper Claudius, MD, PhD, Study Director, Affiliation: Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Jørgen Viby-Mogensen, Prof., DMSc, Study Director, Affiliation: Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Jørgen Lund, MD, Study Director, Affiliation: Department of anaesthesia, Privathospitalet Hamlet A/S, Denmark
Morten Jenstrup, MD, Study Director, Affiliation: Department of anaesthesia, Privathospitalet Hamlet A/S, Denmark
Anne Marie Sørensen, MD, PhD, Study Director, Affiliation: Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark

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.

Official title: Pharmacodynamic Trial on Rocuronium in Obese Patients

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Duration of action, defined as: Time to reappearance of T4.

Secondary outcome:

Complete duration of action, defined as: Time to TOF-ratio = 0.9

Onset time

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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).

Department of anaesthesia, Privathospitalet Hamlet A/S, Copenhagen DK-2000, Denmark

Starting date: October 2007
Last updated: October 15, 2009