Clinical trial NCT00540085: Pharmacodynamic Trial on Rocuronium in Obese Patients
Official title: Pharmacodynamic Trial on Rocuronium in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bariatric Surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-10-05
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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).

Primary outcomes:
measure: Duration of action, defined as: Time to reappearance of T4.
timeFrame: 1 day
Secondary outcomes:
measure: Complete duration of action, defined as: Time to TOF-ratio = 0.9
timeFrame: 1 day
measure: Onset time
timeFrame: 1 day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of anaesthesia, Privathospitalet Hamlet A/S
Study officials:
affiliation: Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
name: Lars S Rasmussen, MD, DMSc
role: STUDY_CHAIR
affiliation: Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
name: Christian S Meyhoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
name: Casper Claudius, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
name: Jørgen Viby-Mogensen, Prof., DMSc
role: STUDY_DIRECTOR
affiliation: Department of anaesthesia, Privathospitalet Hamlet A/S, Denmark
name: Jørgen Lund, MD
role: STUDY_DIRECTOR
affiliation: Department of anaesthesia, Privathospitalet Hamlet A/S, Denmark
name: Morten Jenstrup, MD
role: STUDY_DIRECTOR
affiliation: Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
name: Anne Marie Sørensen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Meyhoff CS, Lund J, Jenstrup MT, Claudius C, Sorensen AM, Viby-Mogensen J, Rasmussen LS. Should dosing of rocuronium in obese patients be based on ideal or corrected body weight? Anesth Analg. 2009 Sep;109(3):787-92. doi: 10.1213/ane.0b013e3181b0826a.