Pharmacodynamic Trial on Rocuronium in Obese Patients

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00540085
First received: October 4, 2007
Last updated: October 15, 2009
Last verified: October 2009
  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 April 16, 2014