Pharmacodynamic Trial on Rocuronium in Obese Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00540085

Enrollment

Registered

2007-10-05

Start date

2007-10-31

Completion date

2008-02-29

Last updated

2009-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery

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.

Interventions

DRUGRocuronium

0.6 mg/kg given intravenously before intubation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
Complete duration of action, defined as: Time to TOF-ratio = 0.9	1 day
Onset time	1 day

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026