복강경 위 절제술을 받는 노인 환자의 술후 섬망 감소를 위한 레미마졸람
복강경 근치적 위 절제술을 받는 노인 환자에서 Remimazolam이 술 후 섬망에 미치는 영향: 전향적 무작위 대조 시험
This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial evaluated whether remimazolam-based anesthesia reduced postoperative delirium (POD) and improved peri-induction hemodynamic stability compared with propofol-midazolam-based anesthesia in patients aged 65 years or older undergoing elective laparoscopic radical gastrectomy for gastric cancer. A total of 147 participants were randomized in a 1:1 ratio. Standardized perioperative management, BIS-guided anesthetic depth control, and postoperative analgesia were applied in both groups. The primary outcome was the cumulative incidence of POD during postoperative days 1-3, assessed once daily using the 3D-CAM or CAM-ICU by trained outcome assessors blinded to treatment allocation. Secondary outcomes included post-induction hypotension, peri-induction hemodynamic variables, postoperative recovery, pain scores, and adverse events.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial was conducted at the First Affiliated Hospital of Nanjing Medical University between January 21 and August 5, 2026. Patients aged 65 years or older who were scheduled to undergo elective laparoscopic radical gastrectomy for gastric cancer were screened for eligibility. A total of 147 participants were randomized in a 1:1 ratio to receive either remimazolam-based anesthesia or propofol-midazolam-based anesthesia. Randomization was based on a computer-generated sequence, with allocation concealed using sequentially numbered, opaque, sealed envelopes. Participants and postoperative outcome assessors were blinded to treatment allocation, whereas the attending anesthesiologists administering the allocated anesthetic regimen were not blinded.
Standardized perioperative monitoring and management were applied in both groups, including bispectral index-guided anesthetic depth control, opioid analgesia, neuromuscular blockade, controlled ventilation, vasoactive medication titration, and postoperative patient-controlled intravenous analgesia. Postoperative delirium was assessed once daily between 14:00 and 17:00 on postoperative days 1-3. Ward patients were assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method, whereas patients admitted to the intensive care unit were assessed using the Confusion Assessment Method for the Intensive Care Unit.
The original protocol specified standardized delirium assessment through postoperative day 5. Owing to limited research personnel during trial implementation, standardized assessments could only be consistently completed through postoperative day 3. Therefore, the primary outcome was the cumulative incidence of POD during postoperative days 1-3, and no assumptions were made regarding delirium status on postoperative days 4 and 5. Secondary outcomes included post-induction hypotension, maximum reduction in mean arterial pressure from baseline, peri-induction vasoactive drug requirements, peri-induction mean arterial pressure, heart rate and bispectral index trajectories, time to extubation, length of stay in the post-anesthesia care unit and hospital, postoperative pain scores, postoperative nausea and vomiting, PACU hypoxemia, emergence agitation, unplanned intensive care unit admission, and postoperative pulmonary infection.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Xiongxiong Pan
- 전화번호: +86 13813801858
- 이메일: xiongxiong@njmu.edu.cn
연구 연락처 백업
- 이름: Siyang Li
- 전화번호: +86 18745228706
- 이메일: hilary37727@163.com
연구 장소
-
-
Jiangsu
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Nanjing, Jiangsu, 중국
- 모병
- The First Affiliated Hospital of Nanjing Medical University
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연락하다:
- Xiongxiong Pan
- 전화번호: +86 13813801858
- 이메일: xiongxiong@njmu.edu.cn
-
연락하다:
- Siyang Li
- 전화번호: +86 18745228706
- 이메일: hilary37727@163.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥ 65 years.
- Body mass index (BMI) between 18 and 28 kg/m².
- ASA physical status I-III.
- Scheduled for elective laparoscopic radical gastrectomy under general anesthesia at Jiangsu Province Hospital.
- Able and willing to sign informed consent.
Exclusion Criteria:
- Severe respiratory, cardiovascular, renal, or hepatic dysfunction.
- Stroke within the past 6 months or other central nervous system diseases.
- History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or other psychiatric disorders.
- History of alcohol abuse or psychoactive substance dependence.
- Severe visual, hearing, or language impairment preventing communication.
- Allergy or contraindication to propofol or benzodiazepines.
- Preoperative cognitive impairment assessed by MMSE (≤24 for ≥middle-school education; ≤20 for primary school; ≤17 for no formal education).
- Participation in another drug clinical trial within 1 month before surgery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Remimazolam Group
Participants in this group will receive remimazolam for anesthesia induction and maintenance during laparoscopic radical gastrectomy. |
Remimazolam will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60. |
|
활성 비교기: Propofol Group
Participants in this group will receive propofol for anesthesia induction and maintenance during laparoscopic radical gastrectomy. |
Propofol will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
incidence of Postoperative Delirium
기간: From postoperative Day 1 to Day 3
|
Postoperative delirium will be assessed using the 3D-CAM diagnostic tool by trained evaluators blinded to group assignment. Delirium will be identified based on the presence of acute onset/fluctuation, inattention, altered consciousness, or disorganized thinking, following the standard 3D-CAM algorithm. |
From postoperative Day 1 to Day 3
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Emergence Agitation
기간: Immediately after extubation until PACU discharge
|
Emergence agitation will be assessed in the PACU using the RASS or agitation scale by blinded evaluators. |
Immediately after extubation until PACU discharge
|
|
Time to extubation
기간: At the end of surgery
|
Time from discontinuation of anesthetic agents to successful tracheal extubation. |
At the end of surgery
|
|
Postoperative Pain Score
기간: At PACU discharge; postoperative day 1,day 2,and day 3.
|
Pain itensity will be evaluated using the Numerical Rating Scale(NRS,0-10) |
At PACU discharge; postoperative day 1,day 2,and day 3.
|
|
Post-induction Hypotension
기간: From completion of anesthetic induction to 10 minutes after induction.
|
Post-induction hypotension will be defined as a decrease in mean arterial pressure (MAP) to <65 mmHg or a reduction of ≥30% from baseline within the first 10 minutes after anesthetic induction. |
From completion of anesthetic induction to 10 minutes after induction.
|
|
Incidence of Postoperative Nausea and Vomiting
기간: From surgery until 48 hours postoperatively
|
Postoperative nausea and vomiting assessed as the presence or absence based on patient reports and medical records during the postoperative period. |
From surgery until 48 hours postoperatively
|
|
Length of Hospital Stay(days)
기간: From the day of surgery (Day 0) to the date of hospital discharge (expected within 7-14 days postoperatively)
|
Length of hospital stay is defined as the number of calendar days from the date of surgery (Day 0) until the date of hospital discharge , as recorded in the electronic medical record system |
From the day of surgery (Day 0) to the date of hospital discharge (expected within 7-14 days postoperatively)
|
공동 작업자 및 조사자
스폰서
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2025-SR-1025
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
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