Pharmacodynamic Trial on Rocuronium in Obese Patients

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery
• Intervention / Treatment: Drug: Rocuronium

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Rocuronium dosed after ideal body weight	Drug: Rocuronium; 0.6 mg/kg given intravenously before intubation; Other Names: Esmeron (R)
Active Comparator: B; Rocuronium dosed after corrected body weight 20%	Drug: Rocuronium; 0.6 mg/kg given intravenously before intubation; Other Names: Esmeron (R)
Active Comparator: C; Rocuronium dosed after corrected body weight 40%	Drug: Rocuronium; 0.6 mg/kg given intravenously before intubation; Other Names: Esmeron (R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of action, defined as: Time to reappearance of T4.	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Complete duration of action, defined as: Time to TOF-ratio = 0.9	1 day
Onset time	1 day

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: October 4, 2007
• First Submitted That Met QC Criteria: October 4, 2007
• First Posted (Estimate): October 5, 2007

Study Record Updates

• Last Update Posted (Estimate): October 16, 2009
• Last Update Submitted That Met QC Criteria: October 15, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: 2007-003005-27; H-B-2007-038