Effect of Fentanyl on Coughing and Recovery After Anesthesia With an LMA Laryngeal Mask Airway)for Airway Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald Wender, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01368809
First received: June 7, 2011
Last updated: October 30, 2013
Last verified: October 2013
  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:


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 day ] [ Designated as safety issue: No ]
    Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.

  • Postoperative pain [ Time Frame: one day ] [ Designated as safety issue: No ]
    Postoperative pain will be measured using a Verbal Rating Scale at PACU.


Enrollment: 100
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Wender, Chairman, Department of Anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01368809     History of Changes
Other Study ID Numbers: Pro00024484
Study First Received: June 7, 2011
Last Updated: October 30, 2013
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
Signs and Symptoms, Respiratory
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014