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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00540085
Date of registration: 04/10/2007
Primary sponsor: Rigshospitalet, Denmark
Public title: Pharmacodynamic Trial on Rocuronium in Obese Patients
Scientific title: Pharmacodynamic Trial on Rocuronium in Obese Patients
Date of first enrolment: October 2007
Target sample size: 51
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00540085
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention  
Countries of recruitment
Denmark
Contacts
Name:   Anne Marie Sørensen, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Name:   Casper Claudius, MD, PhD
Address: 
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Email:
Affiliation:  Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Name:   Christian S Meyhoff, MD, PhD
Address: 
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Email:
Affiliation:  Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Name:   Jørgen Viby-Mogensen, Prof., DMSc
Address: 
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Affiliation:  Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Name:   Lars S Rasmussen, MD, DMSc
Address: 
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Affiliation:  Department of anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Denmark
Name:   Jørgen Lund, MD
Address: 
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Email:
Affiliation:  Department of anaesthesia, Privathospitalet Hamlet A/S, Denmark
Name:   Morten Jenstrup, MD
Address: 
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Affiliation:  Department of anaesthesia, Privathospitalet Hamlet A/S, Denmark
Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Bariatric Surgery
Intervention(s)
Drug: Rocuronium
Primary Outcome(s)
Duration of action, defined as: Time to reappearance of T4. [Time Frame: 1 day]
Secondary Outcome(s)
Complete duration of action, defined as: Time to TOF-ratio = 0.9 [Time Frame: 1 day]
Onset time [Time Frame: 1 day]
Secondary ID(s)
2007-003005-27
H-B-2007-038
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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