- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07597564
Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation
Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation: Prospective Randomized Double-blind Study
This randomized, double-blind, controlled clinical study will evaluate the effects of different dose combinations of intravenous metoprolol and sufentanil on cardiovascular responses during oral endotracheal intubation under general anesthesia.
Endotracheal intubation may cause transient increases in heart rate and blood pressure due to sympathetic stimulation. This study aims to determine whether metoprolol, in combination with different doses of sufentanil, can improve hemodynamic stability during and after intubation.
A total of 900 adult patients aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who are scheduled for elective non-cardiac surgery under general anesthesia with endotracheal intubation will be enrolled. Participants will be randomly assigned to one of 30 groups according to the combination of metoprolol dose and sufentanil dose. Metoprolol doses include 0, 0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg, and sufentanil doses include 0.1, 0.2, 0.3, 0.4, and 0.5 mcg/kg.
All participants will receive standardized anesthetic induction and maintenance. Hemodynamic changes will be observed for 10 minutes after intubation. The main outcome is the success rate of hemodynamic stability within 0 to 10 minutes after intubation. Secondary outcomes include the incidence of hypotension, hypertension, bradycardia, and tachycardia.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Yanhua Guo
- 전화번호: +86-18050333902
- 이메일: guoyanhua19@126.com
연구 장소
-
-
Fujian
-
Fuzhou, Fujian, 중국, 350000
- Fujian Provincial Hospital
-
연락하다:
- Yanhua Guo
- 전화번호: +86-18050333902
- 이메일: guoyanhua19@126.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18 to 65 years.
- American Society of Anesthesiologists physical status I or II.
- Scheduled for elective non-cardiac surgery.
- Planned general anaesthesia with endotracheal intubation.
Exclusion Criteria:
- Cardiovascular or respiratory diseases, such as uncontrolled hypertension or bronchial asthma.
- Current use of β-blockers.
- History of chronic drug use or alcohol abuse.
- Hepatic or renal impairment.
- Known allergy to any study drug.
- Anticipated difficult airway.
- Any other condition that may affect the conduct of the study.
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 |
|---|---|
|
활성 비교기: Metoprolol 0 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
활성 비교기: Metoprolol 0 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
활성 비교기: Metoprolol 0 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
활성 비교기: Metoprolol 0 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
활성 비교기: Metoprolol 0 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
실험적: Metoprolol 0.1 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.1 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.1 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.1 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.1 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.2 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.2 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.2 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.2 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.2 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.3 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.3 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.3 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.3 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.3 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.4 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.4 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.4 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.4 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.4 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.5 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.5 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.5 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.5 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
실험적: Metoprolol 0.5 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Percentage of participants achieving hemodynamic stability after tracheal intubation
기간: within 0-10 min after intubation
|
within 0-10 min after intubation
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
incidence of bradycardia
기간: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of tachycardia
기간: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of hypotension
기간: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of hypertension
기간: within 0-10 min after intubation
|
within 0-10 min after intubation
|
기타 결과 측정
결과 측정 |
기간 |
|---|---|
|
adverse event
기간: up to 24 hours postoperatively
|
up to 24 hours postoperatively
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Yanhua Guo, Fujian Provincial Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
- K2024-03-015/02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .