Pharmacodynamic Trial on Rocuronium in Obese Patients - Full Text View

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00540085

Purpose

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.

Condition	Intervention	Phase
Bariatric Surgery	Drug: Rocuronium	Phase IV

MedlinePlus related topics: Anesthesia Obesity Weight Loss Surgery

Drug Information available for: Rocuronium ORG 9426

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Official Title:	Pharmacodynamic Trial on Rocuronium in Obese Patients

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Duration of action, defined as: Time to reappearance of T4. [ Time Frame: At end of anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Onset time [ Time Frame: At anesthetic induction ] [ Designated as safety issue: No ]
Complete duration of action, defined as: Time to TOF-ratio = 0.9 [ Time Frame: At end of anesthesia ] [ Designated as safety issue: No ]

Enrollment:	51
Study Start Date:	October 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Rocuronium dosed after ideal body weight	Drug: Rocuronium 0.6 mg/kg given intravenously before intubation
B: Active Comparator Rocuronium dosed after corrected body weight 20%	Drug: Rocuronium 0.6 mg/kg given intravenously before intubation
C: Active Comparator Rocuronium dosed after corrected body weight 40%	Drug: Rocuronium 0.6 mg/kg given intravenously before intubation

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540085

Locations

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

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Study Chair:	Lars S Rasmussen, MD, PhD	Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Principal Investigator:	Christian S Meyhoff, MD	Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Study Director:	Casper Claudius, MD	Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Study Director:	Jørgen Viby-Mogensen, Prof., FRAC	Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Study Director:	Jørgen Lund, MD	Department of anaesthesia, Privathospitalet Hamlet A/S, Denmark
Study Director:	Morten Jenstrup, MD	Department of anaesthesia, Privathospitalet Hamlet A/S, Denmark

More Information

Responsible Party:	Department of Anaesthesia, HOC, Copenhagen University Hospital, Rigshospitalet ( Lars S. Rasmussen )
Study ID Numbers:	2007-003005-27, H-B-2007-038
Study First Received:	October 4, 2007
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00540085
Health Authority:	Denmark: National Board of Health

Study placed in the following topic categories:

Obesity
Rocuronium

Additional relevant MeSH terms:

Neuromuscular Nondepolarizing Agents
Physiological Effects of Drugs
Neuromuscular Agents

Neuromuscular Blocking Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009