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The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Huei-Chi Horng, MD, Taichung Armed Forces General Hospital
ClinicalTrials.gov Identifier:
NCT01532466
First received: February 7, 2012
Last updated: February 9, 2012
Last verified: December 2011

February 7, 2012
February 9, 2012
March 2011
October 2011   (final data collection date for primary outcome measure)
Incidence of fentanyl-induced coughing [ Time Frame: 2 minutes ] [ Designated as safety issue: Yes ]
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%).
Same as current
Complete list of historical versions of study NCT01532466 on ClinicalTrials.gov Archive Site
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The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing
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An intravenous bolus of fentanyl often induces a cough reflex. This study investigates whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Fentanyl-induced Coughing
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).
  • 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).
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
November 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01532466
TC100-5
Yes
Huei-Chi Horng, MD, Taichung Armed Forces General Hospital
Taichung Armed Forces General Hospital
Not Provided
Study Director: Chih-Shung Wong, PhD Cathay General Hospital
Taichung Armed Forces General Hospital
December 2011

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