The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing
1 other identifier
interventional
260
1 country
1
Brief Summary
An intravenous bolus of fentanyl often induces a cough reflex. This study investigates whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 7, 2012
CompletedFirst Posted
Study publicly available on registry
February 14, 2012
CompletedFebruary 14, 2012
December 1, 2011
7 months
February 7, 2012
February 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of fentanyl-induced coughing
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%).
2 minutes
Study Arms (2)
Rocuronium, fentanyl-induced cough, normal saline
EXPERIMENTALAll 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).
Normal saline
NO INTERVENTIONAll 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).
Interventions
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).
Eligibility Criteria
You may qualify if:
- ASA I-II patients,
- aged between 18 and 80 years, and undergoing various elective surgeries at Taichung Armed Forces General Hospital.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taichung Armed Forces General Hospital
Taichung, 411, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chih-Shung Wong, PhD
Cathay General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 7, 2012
First Posted
February 14, 2012
Study Start
March 1, 2011
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
February 14, 2012
Record last verified: 2011-12