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CompletedNCT00540085Updated Oct 16, 2009

Pharmacodynamic Trial on Rocuronium in Obese Patients

A Phase 4 interventional study of Rocuronium in Bariatric Surgery, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-10-16.

Sponsored by Rigshospitalet, Denmark · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bariatric Surgery
03

In context

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-65 years.
  • Elective laparoscopic gastric banding or gastric bypass.

Exclusion criteria

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).
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Active comparator
    A

    Rocuronium dosed after ideal body weight

    Drug: Rocuronium

  • Active comparator
    B

    Rocuronium dosed after corrected body weight 20%

    Drug: Rocuronium

  • Active comparator
    C

    Rocuronium dosed after corrected body weight 40%

    Drug: Rocuronium

Interventions

  • DrugRocuronium

    0.6 mg/kg given intravenously before intubation

    Also known as: Esmeron (R)

06

What researchers measure

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

07

Study locations

1 site
  • Department of anaesthesia, Privathospitalet Hamlet A/S
    Copenhagen, DK-2000, Denmark
08

References and documents

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. PubMed 19690247 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00540085
Lead sponsor
Rigshospitalet, Denmark
First posted
Oct 5, 2007
Start date
Oct 2007
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Oct 16, 2009

Study contacts

Lars S Rasmussen, MD, DMSc
study chair · Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Christian S Meyhoff, MD, PhD
principal investigator · Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Casper Claudius, MD, PhD
study director · Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Jørgen Viby-Mogensen, Prof., DMSc
study director · Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Jørgen Lund, MD
study director · Department of anaesthesia, Privathospitalet Hamlet A/S, Denmark
Morten Jenstrup, MD
study director · Department of anaesthesia, Privathospitalet Hamlet A/S, Denmark
Anne Marie Sørensen, MD, PhD
study director · Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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