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Completed

NCT Number: NCT00540085

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.

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Key information

Conditions

Bariatric Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of anaesthesia, Privathospitalet Hamlet A/S

Copenhagen, DK-2000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rocuronium

Drug

0.6 mg/kg given intravenously before intubation

Other names: Esmeron (R)

Primary outcomes

  1. Duration of action, defined as: Time to reappearance of T4.

    Time frame: 1 day

Secondary outcomes

  1. Complete duration of action, defined as: Time to TOF-ratio = 0.9

    Time frame: 1 day

  2. Onset time

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 5, 2007
Registry last updated
Oct 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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