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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01368809
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : October 8, 2015
Last Update Posted : April 5, 2016
Information provided by (Responsible Party):
Ronald Wender, Cedars-Sinai Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Ambulatory Surgery Coughing Drug: Saline Drug: Fentanyl Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Drug: Saline
2 ml at induction 1-2 ml boluses as needed
Other Name: placebo

Primary Outcome Measures :
  1. Incidence of Coughing [ Time Frame: one day ]
    during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.

Secondary Outcome Measures :
  1. Incidence of Nausea and Vomiting [ Time Frame: 1 day ]
    Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.

  2. Postoperative Pain [ Time Frame: one day ]

    Postoperative pain measured using a Verbal Rating Scale (VRS) at post-anesthesia care unit (PACU), (90 minutes after arriving).

    Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • American Society of Anesthesiologists (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01368809

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United States, California
Cedars Sinai Medical center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
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Principal Investigator: Ronald H Wender, MD Cedars-Sinai Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ronald Wender, Chairman, Department of Anesthesiology, Cedars-Sinai Medical Center Identifier: NCT01368809    
Other Study ID Numbers: Pro00024484
First Posted: June 8, 2011    Key Record Dates
Results First Posted: October 8, 2015
Last Update Posted: April 5, 2016
Last Verified: March 2016
Keywords provided by Ronald Wender, Cedars-Sinai Medical Center:
Ambulatory surgery
Pain management
Perioperative outcomes
Coughing during insertion of an LMA
Ambulatory surgery procedures
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General