- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532466
The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing
Study Overview
Detailed Description
Fentanyl is widely used for analgesia and anesthesia because of its rapid onset, its intense analgesic effect, and is associated with lessened cardiovascular depression and low histamine release. Although the cough reflex is usually transient and self-limiting, it should be avoided in situations such as elevated intracranial, intraocular, or intra-abdominal pressure, and unstable hemodynamics.
The cause of FIC is unclear. One hypothesis is that vocal cord spasms might induce coughing because of fentanyl-induced muscle rigidity and histamine release. Muscle relaxants are commonly used to treat this condition. This study hypothesizes that priming muscle relaxants could prevent or suppress FIC. This study investigates whether the muscle relaxant rocuronium attenuates FIC effectively.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taichung, Taiwan, 411
- Taichung Armed Forces General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 260 ASA I-II patients,
- aged between 18 and 80 years, and undergoing various elective surgeries at Taichung Armed Forces General Hospital.
Exclusion Criteria:
- a history of asthma,
- chronic cough,
- smoking,
- upper respiratory tract infection in the previous 2 weeks, and
- medication containing angiotensin-converting enzyme inhibitors or anesthetic premedication.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Rocuronium, fentanyl-induced cough, normal saline
All patients were given oxygen via a face mask.
The patients were then administered with the following medications intravenously: the rocuronium group received rocuronium 0.06 mg kg-1 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s).
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All patients were given oxygen via a face mask.
The patients were then administered with the following medications intravenously: the rocuronium group received rocuronium 0.06 mg kg-1, and the control group received the same volume of normal saline 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s).
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No Intervention: Normal saline
All patients were given oxygen via a face mask.
The patients were then administered with the following medications intravenously: the control group received the same volume of normal saline 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of fentanyl-induced coughing
Time Frame: 2 minutes
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Following the fentanyl injection, another anesthetist who was blind to the pretreatment recorded the number of coughs for 1 min.
The severity of coughing was graded as mild (1-2 times), moderate (3-5 times), or severe (> 5 times) based on the number of coughs within the 1 min following the fentanyl injection.
Assisted mask ventilation with oxygen was supplied if desaturation occurred (SpO2 < 90%).
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2 minutes
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Collaborators and Investigators
Investigators
- Study Director: Chih-Shung Wong, PhD, Cathay General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TC100-5
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