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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-02-28

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.

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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.

Conditions

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Ambulatory Surgery Coughing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fentanyl

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

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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

Saline Solution

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

2 ml at induction 1-2 ml boluses as needed

Interventions

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Saline

2 ml at induction 1-2 ml boluses as needed

Intervention Type DRUG

Fentanyl

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

Intervention Type DRUG

Other Intervention Names

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placebo

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No