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The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing

Primary Purpose

Fentanyl-induced Coughing

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Rocuronium
Sponsored by
Taichung Armed Forces General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fentanyl-induced Coughing focused on measuring fentanyl-induced coughing, rocuronium

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taichung Armed Forces General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rocuronium, fentanyl-induced cough, normal saline

Normal saline

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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%).

Secondary Outcome Measures

Full Information

First Posted
February 7, 2012
Last Updated
February 9, 2012
Sponsor
Taichung Armed Forces General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01532466
Brief Title
The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Armed Forces General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fentanyl-induced Coughing
Keywords
fentanyl-induced coughing, rocuronium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rocuronium, fentanyl-induced cough, normal saline
Arm Type
Experimental
Arm Description
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).
Arm Title
Normal saline
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incidence of fentanyl-induced coughing
Description
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%).
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Shung Wong, PhD
Organizational Affiliation
Cathay General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taichung Armed Forces General Hospital
City
Taichung
ZIP/Postal Code
411
Country
Taiwan

12. IPD Sharing Statement

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The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing

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