전신 마취 유도 전 투약제로서 테길리딘과 수펜타닐 간 기침 반응 비교
서주 의과대학 부속 련운강 병원
In patients undergoing general anesthesia with planned tracheal intubation , a prospective, randomized, controlled study was conducted to record the occurrence of cough 2 minutes after injection of Sufentanil or Tegilerdine. The cough was graded based on the frequency and duration: Grade I, no cough; Grade II, a single mild cough; Grade III, multiple coughs with duration <1 second; Grade IV, continuous coughing with a duration >15 seconds.
연구 개요
상세 설명
Using a computer-generated randomized number table, patients were divided into two groups: the experimental group receiving Tiliglitidine (T group) at 20-50ug/kg, and the control group receiving Sufentanil (S group) at 0.2-0.4 μg/kg. After patients arrived in the operating room, routine monitoring including non-invasive blood pressure, electrocardiogram, and oxygen saturation was performed, and intravenous access was established. Patients were oxygenated and given the study drug before anesthesia induction. No other drugs were administered to the patients before giving the study drug. During anesthesia induction, patients received intravenous injection of Tiliglitide or Sufentanil according to their group. The severity of coughing was graded based on the number of coughing episodes: graded by the number and duration of coughs: Grade I, no cough, breathing regular; Grade II, a single mild cough; Grade III, multiple coughs, lasting less than 15 seconds; Grade IV, continuous coughs, lasting more than 15 seconds.
This study was single-blind，the attending anesthesiologist could not be blinded to group allocation. However, the investigator who assessed cough, the patients, the intraoperative data recording nurse, the data collectors, and the statistician were all blinded.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Jiangsu
-
Lianyungang, Jiangsu, 중국
- The Affiliated Lianyungang Hospital of Xuzhou Medical University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age between 18 and 65 years, 18 ≤ BMI (kg/m²) ≤ 30;
- ASA grade I ~ III;
- Scheduled elective surgery under general anesthesia with tracheal intubation.
Exclusion Criteria:
- Patients with chronic cough (cough lasting >8 weeks) or asthma;
- Patients with a history of allergy to the drugs used during the study;
- Patients with severe cardiovascular disease, intracranial lesions, eye lesions, or lung lesions.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Tegilerdine group
Administer 20-50µ/kg of Tegilerdine before induction of general anesthesia, and record the patient's coughing episodes 2 minutes after administration. Then proceed with anesthesia induction. |
Inject Tegilerdine in the induction of general anesthesia |
|
활성 비교기: Sufentanil group
Administer sufentanil 0.2-0.4 µg/kg before the induction of general anesthesia, and record the patient's coughing episodes 2 minutes after administration. Then proceed with anesthesia induction. |
Inject Sufentanil in the induction of general anesthesia |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of choking cough response
기간: 2 minutes after administration
|
Two minutes after administration of the study drugs (Tegilerdine/Sufentanil), any clear coughing action is considered an 'occurrence'. |
2 minutes after administration
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Grading of choking and coughing response
기간: 2 minutes after administration
|
Grading based on the number and duration of coughs: Grade I, no coughing, breathing is even; Grade II, a single mild cough; Grade III, multiple coughs lasting less than 15 seconds; Grade IV, continuous coughing lasting more than 15 seconds |
2 minutes after administration
|
|
Blood pressure
기간: before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4）
|
Blood pressure before and after administration, and before and after intubation |
before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4）
|
|
Heart rate
기간: before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4）
|
heart rate before and after administration, and before and after intubation |
before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4）
|
|
Adverse reaction
기간: 2 minutes after administration
|
such as respiratory depression, vomiting, nausea, itching, etc.) |
2 minutes after administration
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Xiaobao Zhang, Doctor, Xuzhou Medical University Affiliated Hospital of Lianyungang: Lianyungang No 1 People's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KY-20250815003-01
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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