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

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

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.

Study Overview

• Status: Completed
• Conditions: Coughing; Ambulatory Surgery
• Intervention / Treatment: Drug: Fentanyl; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Coughing	during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Nausea and Vomiting	Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.	1 day
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.	one day

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Estimate): April 5, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Pain management; Fentanyl; Ambulatory surgery; Perioperative outcomes; Coughing during insertion of an LMA; Ambulatory surgery procedures
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: Pro00024484