The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing

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

Tracking Information

• First Submitted Date: February 7, 2012
• First Posted Date: February 14, 2012
• Last Update Posted Date: February 14, 2012
• Study Start Date: March 2011
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Fentanyl-induced Coughing

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 9, 2012): 260
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2011
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT01532466
• Other Study ID Numbers: TC100-5
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Huei-Chi Horng, MD, Taichung Armed Forces General Hospital
• Study Sponsor: Taichung Armed Forces General Hospital
• Collaborators: Not Provided

Investigators

• Study Director: Chih-Shung Wong, PhD; Cathay General Hospital

• PRS Account: Taichung Armed Forces General Hospital
• Verification Date: December 2011