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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fentanyl-induced Coughing Drug: Rocuronium Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : March 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arms and Interventions
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Arm Intervention/treatment
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).
 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).
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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%).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532466


Locations
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Taiwan
Taichung Armed Forces General Hospital
Taichung, Taiwan, 411
Sponsors and Collaborators
Taichung Armed Forces General Hospital
Investigators
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Study Director: Chih-Shung Wong, PhD Cathay General Hospital
More Information
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Responsible Party: Huei-Chi Horng, MD, Principal Investigator, Taichung Armed Forces General Hospital
ClinicalTrials.gov Identifier: NCT01532466    
Other Study ID Numbers: TC100-5
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: December 2011
Keywords provided by Huei-Chi Horng, MD, Taichung Armed Forces General Hospital:
fentanyl-induced coughing, rocuronium
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Rocuronium
 Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs