Phase 4
Completed N=100
Effect of Fentanyl on Coughing and Recovery After Anesthesia With an LMA Laryngeal Mask Airway)for Airway Management
Ambulatory Surgery · Coughing
Source: ClinicalTrials.gov NCT01368809 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Incidence of Coughing — 10; 6 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Coughing |
10; 6 | — |
| SECONDARY Incidence of Nausea and Vomiting |
2; 4 | — |
| SECONDARY Postoperative Pain |
1.5; 1.5 | — |
Eligibility 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
- 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.
Data sourced from ClinicalTrials.gov (NCT01368809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.