The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing

Not Applicable

Completed

• Conditions: Fentanyl-induced Coughing
• Interventions: Drug: Rocuronium

• Registration Number: NCT01532466
• Lead Sponsor: Taichung Armed Forces General Hospital

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 Timeline

• Study Start: 2011-03
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Status Verified: 2011-12
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-09
• Last Update Submitted: 2012-02-09
• Study First Posted: 2012-02-14
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocuronium, fentanyl-induced cough, normal saline	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 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s).

Primary Outcome Measures

Name	Time	Method
Incidence of fentanyl-induced coughing	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%).

Trial Locations

Locations (1)

Taichung Armed Forces General Hospital; 🇨🇳 Taichung, Taiwan