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

NCT01368809 | Completed Phase 4 Results

• 1 other identifier: Pro00024484
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ambulatory Surgery; Coughing

Keywords

Ambulatory surgery; Pain management; Perioperative outcomes; Fentanyl; Coughing during insertion of an LMA; Ambulatory surgery procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Nausea and Vomiting

  1 day

• Postoperative Pain

  one day

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

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

Drug: Fentanyl

Saline Solution

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Saline DRUG

2 ml at induction 1-2 ml boluses as needed

Also known as: placebo

Saline Solution

Fentanyl DRUG

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

Fentanyl

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo outpatient arthroscopic surgery procedures
• Willingness and ability to sign an informed consent document
• No allergies to anesthetic or analgesic medications
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• 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.

  PMID: 25329822 DERIVED

MeSH Terms

Conditions

Cough; Agnosia

Interventions

Sodium Chloride; Fentanyl

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Paul F White
• Organization: Department of Anesthesiology at Cedars-Sinai Medical Center in Los Angeles

paul.white@cshs.org

214-7703775

Study Officials

• Ronald H Wender, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Anesthesiology

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 8, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 5, 2016
• Results First Posted: October 8, 2015

Record last verified: 2016-03

Locations

US (1)