Effect of Fentanyl on Coughing and Recovery After Anesthesia With an LMA for Airway Management - Full Text View

Purpose

The purpose of this research is to evaluate the effectiveness of fentanyl for reducing coughing during the perioperative period (i.e., insertion of an LMA [Laryngeal Mask Airway] device, maintenance period during surgery, and awakening [emergence] from general anesthesia) for ambulatory surgery procedures. Also to assess the effects of fentanyl on the postoperative outcomes, (e.g., pain, postoperative nausea and vomiting, return of bowel function [constipation], resumption of normal activities of daily living).

Fentanyl is one of the most common used anesthetic adjuncts for ambulatory surgery because of its anesthetic-sparing effects and alleged ability to reduce coughing during instrumentation of the patient's airway.

Condition	Intervention	Phase
Ambulatory Surgery Coughing	Drug: Fentanyl Other: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effect of Fentanyl on the Incidence of Coughing and Recovery After Propofol-Desflurane Anesthesia With an LMA for Airway Management

Resource links provided by NLM:

MedlinePlus related topics: Cough Nausea and Vomiting

Drug Information available for: Fentanyl Fentanyl citrate

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:

Incidence of coughing [ Time Frame: one day ] [ Designated as safety issue: No ]
during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.

Secondary Outcome Measures:

Nausea and vomiting [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit, and one week after surgery.
Postoperative pain [ Time Frame: one week ] [ Designated as safety issue: No ]
Postoperative pain will be measured using a Verbal Rating Scale at PACU and one week after surgery.

Estimated Enrollment:	100
Study Start Date:	June 2011
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Fentanyl Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed	Drug: Fentanyl Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
Placebo Comparator: Saline Solution Saline Solution 2 ml at induction, 1-2 ml boluses as needed	Other: Placebo 2 ml at induction 1-2 ml boluses as needed

Detailed Description:

This research study is designed to evaluate the effects of fentanyl when administered as an adjuvant to standard anesthetic and analgesic drugs on coughing (during insertion of an LMA device, during maintenance and emergence from general anesthesia) and on the postoperative adverse outcomes (i.e., side effects).

All patients will receive local anesthetics and commonly used non-opioid pain relieving medications during surgery.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients scheduled to undergo outpatient arthroscopic surgery procedures
Willingness and ability to sign an informed consent document
No allergies to anesthetic or analgesic medications
18 - 80 years of age
ASA Class I - III adults of either sex
Women of childbearing potential must be currently practicing an acceptable form of birth control, and have a negative urine pregnancy test

Exclusion Criteria

Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, peptic ulcer disease or bleeding disorders
Pregnant or lactating women
Subjects with a history of alcohol or drug abuse within the past 3 months
Any other conditions or use of any medication which may interfere with the conduct of the study (e.g., asthmatic patients history of asthma, chronic cough, or upper respiratory tract infection during the previous 2 wk or recent treatment with angiotensin-converting enzyme inhibitors, bronchodilators, or steroids.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368809

Locations

United States, California
Cedars Sinai Medical center
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

Principal Investigator:

Ronald H Wender, MD

Cedars-Sinai Medical Center

More Information

No publications provided

Responsible Party:	Ronald H. Wender, Cedars Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT01368809 History of Changes
Other Study ID Numbers:	Pro00024484
Study First Received:	June 7, 2011
Last Updated:	June 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:

ambulatory surgery
Pain management
Perioperative outcomes

Fentanyl
coughing during insertion of an LMA
ambulatory surgery procedures

Additional relevant MeSH terms:

Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Anesthetics
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013