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

Primary Purpose

Ambulatory Surgery, Coughing

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Saline
Fentanyl
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ambulatory Surgery focused on measuring Ambulatory surgery, Pain management, Perioperative outcomes, Fentanyl, Coughing during insertion of an LMA, Ambulatory surgery procedures

Eligibility Criteria

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

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.

Sites / Locations

  • Cedars Sinai Medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fentanyl

Saline Solution

Arm Description

Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed

Saline Solution 2 ml at induction, 1-2 ml boluses as needed

Outcomes

Primary Outcome Measures

Incidence of Coughing
during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.

Secondary Outcome Measures

Incidence of Nausea and Vomiting
Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.
Postoperative Pain
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.

Full Information

First Posted
June 7, 2011
Last Updated
March 9, 2016
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01368809
Brief Title
Effect of Fentanyl on Coughing and Recovery After Anesthesia With an LMA Laryngeal Mask Airway)for Airway Management
Acronym
LMA
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ambulatory Surgery, Coughing
Keywords
Ambulatory surgery, Pain management, Perioperative outcomes, Fentanyl, Coughing during insertion of an LMA, Ambulatory surgery procedures

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
Arm Title
Saline Solution
Arm Type
Placebo Comparator
Arm Description
Saline Solution 2 ml at induction, 1-2 ml boluses as needed
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
placebo
Intervention Description
2 ml at induction 1-2 ml boluses as needed
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
Primary Outcome Measure Information:
Title
Incidence of Coughing
Description
during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.
Time Frame
one day
Secondary Outcome Measure Information:
Title
Incidence of Nausea and Vomiting
Description
Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.
Time Frame
1 day
Title
Postoperative Pain
Description
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.
Time Frame
one day

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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald H Wender, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25329822
Citation
White PF, Elvir-Lazo OL, Zaentz AS, Kariger R, Yumul R, Khany MM, Stern A, Vuong M, Wender RH. Does small-dose fentanyl improve perioperative outcomes in the ambulatory setting? A randomized, double-blind, placebo-controlled study. Acta Anaesthesiol Scand. 2015 Jan;59(1):56-64. doi: 10.1111/aas.12424. Epub 2014 Oct 20.
Results Reference
derived

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

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