The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing

NCT ID: NCT01532466

Last Updated: 2012-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-11-30

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.

Conditions

Fentanyl-induced Coughing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Rocuronium

Intervention Type: DRUG

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).

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taichung Armed Forces General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Huei-Chi Horng, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chih-Shung Wong, PhD

Role: STUDY_DIRECTOR

Cathay General Hospital

Locations

Taichung Armed Forces General Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

TC100-5

Identifier Type: -

Identifier Source: org_study_id