Postoperative Cognitive Function After Different Anesthetic Techniques in Obese Patients
Effects of Low-Flow Sevoflurane, Normal-Flow Sevoflurane, and Total Intravenous Anesthesia on Postoperative Cognitive Function in Obese Patients Undergoing Laparoscopic Abdominal Surgery
연구 개요
상태
상세 설명
Obesity is associated with physiological alterations that may increase the risk of postoperative cognitive dysfunction (POCD). The influence of anesthetic techniques on postoperative cognitive outcomes in obese patients remains uncertain.
This prospective randomized study was conducted in obese patients (BMI ≥30 kg/m²) aged 18-65 years undergoing elective laparoscopic abdominal surgery under general anesthesia. Patients were randomly assigned to one of three groups: low-flow sevoflurane anesthesia, normal-flow sevoflurane anesthesia, or total intravenous anesthesia (TIVA). Anesthetic depth was monitored using bispectral index (BIS) monitoring and maintained between 40 and 60 in all groups.
The primary objective was to compare postoperative cognitive function among the three anesthetic techniques using the Mini-Mental State Examination (MMSE). MMSE scores were evaluated preoperatively, at postoperative 30 minutes, and on postoperative day 3.
Secondary objectives included comparison of recovery characteristics, including eye-opening time, extubation time, Modified Aldrete Recovery Scores, and perioperative hemodynamic parameters.
The study was approved by the Marmara University Faculty of Medicine Clinical Research Ethics Committee (Approval No. 09.2022.744) and written informed consent was obtained from all participants before enrollment.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye), 34899
- Marmara University Faculty of Medicine Pendik Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age between 18 and 65 years
- Body mass index (BMI) ≥30 kg/m²
- ASA physical status I-III
- Scheduled for elective laparoscopic abdominal surgery
- Provision of written informed consent
Exclusion Criteria:
- History of psychiatric disease
- Dementia or known cognitive impairment
- Hearing or language disorders preventing MMSE assessment
- Refusal to participate
- Conversion from laparoscopic to open surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Low-Flow Sevoflurane
Patients received sevoflurane anesthesia with a fresh gas flow of 1 L/min during maintenance of anesthesia.
Anesthetic depth was maintained with BIS values between 40 and 60.
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Maintenance of general anesthesia with sevoflurane inhalation.
Patients were assigned to either low-flow (1 L/min) or normal-flow (3 L/min) fresh gas flow anesthesia protocols.
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실험적: Normal-Flow Sevoflurane
Patients received sevoflurane anesthesia with a fresh gas flow of 3 L/min during maintenance of anesthesia.
Anesthetic depth was maintained with BIS values between 40 and 60.
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Maintenance of general anesthesia with sevoflurane inhalation.
Patients were assigned to either low-flow (1 L/min) or normal-flow (3 L/min) fresh gas flow anesthesia protocols.
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실험적: Total Intravenous Anesthesia (TIVA)
Patients received total intravenous anesthesia with propofol and remifentanil infusion.
Anesthetic depth was maintained with BIS values between 40 and 60.
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Maintenance of total intravenous anesthesia using continuous propofol infusion under BIS monitoring.
Continuous remifentanil infusion was administered during maintenance of anesthesia according to study protocol.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mini-Mental State Examination (MMSE) Score
기간: Preoperative, postoperative 30 minutes, and postoperative day 3
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Postoperative cognitive function assessed using the Mini-Mental State Examination (MMSE).
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Preoperative, postoperative 30 minutes, and postoperative day 3
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Eye Opening Time
기간: End of surgery
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Time from discontinuation of anesthetic administration to spontaneous eye opening
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End of surgery
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Extubation Time
기간: End of surgery
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Time from discontinuation of anesthetic administration to tracheal extubation.
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End of surgery
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Modified Aldrete Recovery Score
기간: Postoperative recovery period
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Recovery status assessed using the Modified Aldrete Score.
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Postoperative recovery period
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heart rate
기간: During surgery
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patient's intraoperative measured heart rate
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During surgery
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mean arterial pressure
기간: during surgery
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patient's intraoperative measured mean arterial pressure
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during surgery
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oxygen saturation
기간: During surgery
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oxygen saturation of the patient will be recorded
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During surgery
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end-tidal carbon dioxide
기간: During surgery
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end-tidal carbon dioxide of the patient will be recorded
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During surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ahmet Tunca, MD, Department of Anesthesiology and Reanimation, Gaziantep City Hospital
- 연구 의자: Seniyye Ü Zengin, MD, Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital
- 연구 책임자: Meliha O Ergün, MD, Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research 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
- MU-09.2022.744
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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