Pharmacodynamic Trial on Rocuronium in Obese Patients

Bariatric Surgery Clinical Trial

Official title:

Pharmacodynamic Trial on Rocuronium in Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540085
• Other study ID #: 2007-003005-27
• Secondary ID: H-B-2007-038
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2007
• Last updated: October 15, 2009
• Start date: October 2007
• Est. completion date: February 2008

Study information

• Verified date: October 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Drug:
• Rocuronium
0.6 mg/kg given intravenously before intubation

Locations

Country	Name	City	State
Denmark	Department of anaesthesia, Privathospitalet Hamlet A/S	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Meyhoff CS, Lund J, Jenstrup MT, Claudius C, Sørensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of action, defined as: Time to reappearance of T4.		1 day	No
Secondary	Complete duration of action, defined as: Time to TOF-ratio = 0.9		1 day	No
Secondary	Onset time		1 day	No