NCT00540085

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

4 months

First QC Date

October 4, 2007

Last Update Submit

October 15, 2009

Conditions

Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

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

    1 day

Secondary Outcomes (2)

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

    1 day

  • Onset time

    1 day

Study Arms (3)

A

ACTIVE COMPARATOR

Rocuronium dosed after ideal body weight

Drug: Rocuronium

B

ACTIVE COMPARATOR

Rocuronium dosed after corrected body weight 20%

Drug: Rocuronium

C

ACTIVE COMPARATOR

Rocuronium dosed after corrected body weight 40%

Drug: Rocuronium

Interventions

RocuroniumDRUG

0.6 mg/kg given intravenously before intubation

Also known as: Esmeron (R)
ABC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anaesthesia, Privathospitalet Hamlet A/S

Copenhagen, DK-2000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 19690247RESULT

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Lars S Rasmussen, MD, DMSc

    Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark

    STUDY CHAIR

  • Christian S Meyhoff, MD, PhD

    Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 5, 2007

Study Start

October 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

DK(1)