Pharmacodynamic Trial on Rocuronium in Obese Patients
This study has been completed.
Sponsor:
Rigshospitalet, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00540085
First received: October 4, 2007
Last updated: October 15, 2009
Last verified: October 2009
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Pharmacodynamic Trial on Rocuronium in Obese Patients |
Resource links provided by NLM:
Further study details as provided by Rigshospitalet, Denmark:
Primary Outcome Measures:
- Duration of action, defined as: Time to reappearance of T4. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Complete duration of action, defined as: Time to TOF-ratio = 0.9 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Onset time [ Time Frame: 1 day ] [ 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 |
|---|---|
|
Active Comparator: A
Rocuronium dosed after ideal body weight
|
Drug: Rocuronium
0.6 mg/kg given intravenously before intubation
Other Name: Esmeron (R)
|
|
Active Comparator: B
Rocuronium dosed after corrected body weight 20%
|
Drug: Rocuronium
0.6 mg/kg given intravenously before intubation
Other Name: Esmeron (R)
|
|
Active Comparator: C
Rocuronium dosed after corrected body weight 40%
|
Drug: Rocuronium
0.6 mg/kg given intravenously before intubation
Other Name: Esmeron (R)
|
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, DMSc | Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark |
| Principal Investigator: | Christian S Meyhoff, MD, PhD | Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark |
| Study Director: | Casper Claudius, MD, PhD | Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark |
| Study Director: | Jørgen Viby-Mogensen, Prof., DMSc | 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 |
| Study Director: | Anne Marie Sørensen, MD, PhD | Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark |
More Information
Publications:
| Responsible Party: | Lars S. Rasmussen, Department of Anaesthesia, HOC, Copenhagen University Hospital, Rigshospitalet |
| ClinicalTrials.gov Identifier: | NCT00540085 History of Changes |
| Other Study ID Numbers: | 2007-003005-27, H-B-2007-038 |
| Study First Received: | October 4, 2007 |
| Last Updated: | October 15, 2009 |
| Health Authority: | Denmark: National Board of Health |
Additional relevant MeSH terms:
|
Rocuronium Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013