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
  Purpose

An intravenous bolus of fentanyl often induces a cough reflex. This study investigates whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.


Condition Intervention
Fentanyl-induced Coughing
Drug: Rocuronium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Taichung Armed Forces General Hospital:

Primary Outcome Measures:
  • 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%).


Enrollment: 260
Study Start Date: March 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532466

Locations
Taiwan
Taichung Armed Forces General Hospital
Taichung, Taiwan, 411
Sponsors and Collaborators
Taichung Armed Forces General Hospital
Investigators
Study Director: Chih-Shung Wong, PhD Cathay General Hospital
  More Information

No publications provided

Responsible Party: Huei-Chi Horng, MD, Principal Investigator, Taichung Armed Forces General Hospital
ClinicalTrials.gov Identifier: NCT01532466     History of Changes
Other Study ID Numbers: TC100-5
Study First Received: February 7, 2012
Last Updated: February 9, 2012
Health Authority: Taiwan: Department of Health
United States: Federal Government

Keywords provided by Taichung Armed Forces General Hospital:
fentanyl-induced coughing, rocuronium

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Fentanyl
Rocuronium
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents

ClinicalTrials.gov processed this record on April 17, 2014