Trial | NCT00540085  Report issue

Official Title

Pharmacodynamic Trial on Rocuronium in Obese Patients

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rocuronium ...

  • Study Participants

    51
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 Started
Oct 31
2007
Primary Completion
Feb 29
2008
Study Completion
Feb 29
2008
Last Update
Oct 16
2009
Estimate

Drug Rocuronium

0.6 mg/kg given intravenously before intubation

  • Other names: Esmeron (R)

A Active Comparator

Rocuronium dosed after ideal body weight

B Active Comparator

Rocuronium dosed after corrected body weight 20%

C Active Comparator

Rocuronium dosed after corrected body weight 40%

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).
No Results Posted