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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ambulatory Surgery, Coughing

Intervention / Treatment
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* Drug: Saline
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fentanyl<br>Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed | Drug: Fentanyl<br>* Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed<br>|
| Placebo Comparator: Saline Solution<br>Saline Solution 2 ml at induction, 1-2 ml boluses as needed | Drug: Saline<br>* 2 ml at induction 1-2 ml boluses as needed<br>* Other names: placebo;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ambulatory surgery, Pain management, Perioperative outcomes, Fentanyl, Coughing during insertion of an LMA, Ambulatory surgery procedures