Effect of Fentanyl on Coughing and Recovery After Anesthesia With an LMA Laryngeal Mask Airway)for Airway Management (LMA)
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
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90048
- Cedars Sinai Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Fentanyl
Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
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Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
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위약 비교기: Saline Solution
Saline Solution 2 ml at induction, 1-2 ml boluses as needed
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2 ml at induction 1-2 ml boluses as needed
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Coughing
기간: one day
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during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.
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one day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Nausea and Vomiting
기간: 1 day
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Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.
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1 day
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Postoperative Pain
기간: one day
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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
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00024484
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