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The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing

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ClinicalTrials.gov Identifier: NCT01532466
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
Huei-Chi Horng, MD, Taichung Armed Forces General Hospital

Tracking Information
First Submitted Date  ICMJE February 7, 2012
First Posted Date  ICMJE February 14, 2012
Last Update Posted Date February 14, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Incidence of fentanyl-induced coughing [ Time Frame: 2 minutes ]
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%).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing
Official Title  ICMJE Not Provided
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Fentanyl-induced Coughing
Intervention  ICMJE Drug: Rocuronium
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).
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Rocuronium
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2012)
260
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01532466
Other Study ID Numbers  ICMJE TC100-5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Huei-Chi Horng, MD, Taichung Armed Forces General Hospital
Study Sponsor  ICMJE Taichung Armed Forces General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chih-Shung Wong, PhD Cathay General Hospital
PRS Account Taichung Armed Forces General Hospital
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP