Impact of Entropy Monitoring on Anesthetic Consumption and Recovery After Laparoscopic Cholecystectomy
Effect of Entropy Monitoring on Sevoflurane Consumption and Recovery From General Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy
The goal of this clinical trial is to learn if brainwave-guided anesthesia (entropy monitoring) can reduce anesthetic drug consumption and speed up recovery time in adult patients undergoing elective laparoscopic cholecystectomy surgery under general anesthesia.
The main questions it aims to answer are:
- Does entropy monitoring significantly decrease the mean consumption rate of sevoflurane gas (in mL/hr) compared to traditional clinical monitoring during surgery?
- Does entropy monitoring significantly reduce the mean recovery time (in minutes to open eyes on verbal command) after discontinuing anesthesia? Researchers will compare patients whose anesthesia depth is guided by real-time entropy monitoring (brainwave and facial muscle sensors) to patients whose anesthesia is guided by standard clinical signs (heart rate and blood pressure) to see if using entropy sensors reduces total anesthetic gas use and enables faster patient recovery.
Participants will:
- Receive routine pre-medication and general anesthesia induction for elective laparoscopic cholecystectomy.
- Have continuous monitoring during surgery using either entropy brain/muscle sensors (Group A) or standard clinical vital signs (Group B) to guide the delivery of sevoflurane gas.
- Have their total sevoflurane gas consumption rate automatically recorded at the end of surgery.
- Be assessed after surgery for recovery time, measured in minutes from the time sevoflurane is turned off until they open their eyes upon verbal command.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Muhammad Ali, MBBS
- 전화번호: +923334214946
- 이메일: muhammadali_waseem@yahoo.com
연구 장소
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-
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Islamabad, 파키스탄, 44000
- 모병
- KRL Hospital Islamabad
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연락하다:
- Dr Humaira Jadoon, MBBS FCPS
- 전화번호: +92512852333
- 이메일: drhumairajadoon@gmail.com
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- ASA I or II
- Elective laparoscopic cholecystectomy under GA
Exclusion Criteria:
- Emergency cholecystectomy
- Co Morbid (Hypertension, Diabetes Mellitus, Ischemic Heart Disease, Chronic Kidney Disease, Asthma, Stroke)
- Known allergy or contraindication to sevoflurane or study drugs
- Addictions such as chronic use of sedatives, hypnotics or alcohol abuse on medical records
- BMI of 30 or greater (Obese patients tend to have delated recovery from general anesthesia)
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Group A: Entropy Monitored Group
Device/Protocol: General anesthesia managed with Entropy Monitoring (GE Carestation 650). The anesthesiologist adjusts sevoflurane depth using real-time brain (EEG) and muscle (EMG) signals to maintain Response Entropy (RE) and State Entropy (SE) levels between 40 and 60, keeping the RE-SE difference under 10 |
Participants will receive general anesthesia via GE Carestation 650 Anesthesia Workstation equipped with Entropy module, maintained with sevoflurane in oxygen and air. Standard pre-medication (Midazolam 0.01-0.1 mg/kg and Nalbuphine 0.1 mg/kg), induction (Propofol in 10 mg increments), and neuromuscular blockade (Atracurium 0.5 mg/kg with NMT monitoring) will be administered. Anesthetic depth will be continuously monitored using forehead EEG/EMG sensors. The anesthesiologist will titrate the concentration of inhaled sevoflurane to maintain:
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활성 비교기: Group B: Clinically Monitored Group
Standard Care: General anesthesia managed using Standard Clinical Signs. The anesthesiologist adjusts sevoflurane levels based on standard clinical indicators (blood pressure, heart rate within ±20% of baseline, tearing, etc.) without using entropy numbers to guide drug dosing. |
Participants will receive identical general anesthesia premedication, induction, and airway management protocols (Midazolam, Nalbuphine, Propofol, Atracurium, and maintenance with sevoflurane in oxygen and air) as Group A. Anesthetic depth will be guided strictly using traditional clinical parameters without the aid of entropy numbers. The anesthesiologist will titrate the concentration of inhaled sevoflurane to maintain: Heart rate (HR) within ±20% of the patient's baseline value. Mean Arterial Pressure (MAP) within ±20% of the patient's baseline value. Clinical signs of light anesthesia (e.g., somatic movement, excessive lacrimation, or sweating). |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sevoflurane Consumption
기간: End of surgery (from induction of anesthesia until gas discontinuation)
|
Total volume of liquid sevoflurane vaporized and delivered to the patient per hour. Automatically recorded by the GE Carestation 650 workstation |
End of surgery (from induction of anesthesia until gas discontinuation)
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Recovery Time
기간: From discontinuation of sevoflurane gas up to 60 minutes post-procedure
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Time required for the patient to open their eyes following a verbal command after the flow of sevoflurane gas is turned off at the end of surgery |
From discontinuation of sevoflurane gas up to 60 minutes post-procedure
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공동 작업자 및 조사자
수사관
수사관
- 연구 의자: Dr Humaira Jadoon, MBBS, FCPS Anesthesia, KRL Hospital, Islamabad
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
기타 연구 ID 번호
기타 연구 ID 번호
- KRLHIslamabad
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
There is no plan to make IPD available
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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