The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing

Fentanyl-induced Coughing Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532466
• Other study ID #: TC100-5
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: February 9, 2012
• Start date: March 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Taichung Armed Forces General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cough
• 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).

Locations

Country	Name	City	State
Taiwan	Taichung Armed Forces General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Armed Forces General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of fentanyl-induced coughing	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%).	2 minutes	Yes