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

Information source: Cedars-Sinai Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ambulatory Surgery; Coughing

Intervention: Saline (Drug); Fentanyl (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Cedars-Sinai Medical Center

Official(s) and/or principal investigator(s):
Ronald H Wender, MD, Principal Investigator, Affiliation: Cedars-Sinai Medical Center

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Incidence of coughing

Secondary outcome:

Nausea and vomiting

Postoperative pain

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

- 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.

Locations and Contacts

Cedars Sinai Medical center, Los Angeles, California 90048, United States
Additional Information

Starting date: June 2011
Last updated: February 26, 2015

Page last updated: August 23, 2015

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