Remifentanil vs Esmolol During Intubation for Cerebral Aneurysm Coil Embolization
Effects of Remifentanil Versus Esmolol on Optic Nerve Sheath Diameter/Eyeball Transverse Diameter Ratio During Endotracheal Intubation in Patients Undergoing Cerebral Aneurysm Coil Embolization: A Randomized Controlled Trial
Endotracheal intubation may cause significant increases in blood pressure, heart rate, and intracranial pressure, particularly in patients undergoing cerebral aneurysm coil embolization. Remifentanil and esmolol are commonly used agents to attenuate these responses during anesthesia induction.
This randomized controlled trial aims to compare the effects of remifentanil and esmolol administered before endotracheal intubation on optic nerve sheath diameter/eyeball transverse diameter ratio (ONSD/ETD), a noninvasive surrogate marker of intracranial pressure, as well as hemodynamic responses in patients undergoing elective cerebral aneurysm coil embolization.
The findings may help identify the most effective strategy for minimizing intubation-related intracranial pressure changes and hemodynamic fluctuations in neurointerventional anesthesia practice.
연구 개요
상세 설명
Endotracheal intubation is one of the most stimulating periods during induction of general anesthesia and is associated with transient increases in blood pressure, heart rate, and intracranial pressure. These responses may be particularly important in patients undergoing cerebral aneurysm coil embolization, where excessive hemodynamic fluctuations and increases in intracranial pressure may adversely affect procedural safety.
Optic nerve sheath diameter (ONSD) measured by ultrasonography has emerged as a noninvasive marker of intracranial pressure. The optic nerve sheath diameter-to-eyeball transverse diameter ratio (ONSD/ETD) has been proposed as a more standardized parameter that may reduce interindividual variability.
Remifentanil and esmolol are widely used agents for attenuation of the hemodynamic response to endotracheal intubation. Although both agents have been shown to reduce sympathetic activation during airway manipulation, their comparative effects on ONSD/ETD ratio and intubation-related intracranial pressure changes in patients undergoing neurointerventional procedures remain unclear.
The aim of this prospective randomized controlled trial is to compare the effects of remifentanil and esmolol administered before endotracheal intubation on ONSD/ETD ratio and hemodynamic parameters in adult patients undergoing elective cerebral aneurysm coil embolization. Participants will be randomized in a 1:1 ratio to receive either remifentanil (0.5-1 µg/kg IV) or esmolol (0.5-1 mg/kg IV) administered over 90 seconds before intubation.
ONSD/ETD measurements and hemodynamic parameters will be recorded before intubation (T0), 5 minutes after intubation (T1), and 10 minutes after intubation (T2). The primary outcome will be the change in ONSD/ETD ratio at 5 minutes after intubation. Secondary outcomes include changes in ONSD/ETD ratio at 10 minutes, mean arterial pressure, heart rate, and vasopressor requirements.
The results of this study may provide evidence regarding the optimal pharmacological strategy for attenuating intubation-related intracranial pressure changes and hemodynamic responses in patients undergoing cerebral aneurysm coil embolization.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Arsen Güngör Ay, MD
- 전화번호: +905534948426
- 이메일: arsen.gungor@hotmail.com
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
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연락하다:
- Arsen Güngör Ay, MD
- 전화번호: 0905534948426
- 이메일: arsen.gungor@hotmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age ≥18 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective cerebral aneurysm coil embolization under general anesthesia
- Planned endotracheal intubation
- Ability to provide written informed consent
Exclusion Criteria:
- Emergency procedures
- Hemodynamic instability before induction of anesthesia
- Severe cardiac conduction abnormalities or clinically significant arrhythmias
- Contraindication or allergy to remifentanil or esmolol
- Chronic opioid use or opioid dependence
- Known orbital disease, ocular trauma, or conditions interfering with optic nerve sheath diameter measurements
- Anticipated difficult airway
- Pregnancy
- Refusal to participate in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: remifentanil group
Participants will receive remifentanil 0.5-1 µg/kg intravenously over 90 seconds before endotracheal intubation during induction of general anesthesia for elective cerebral aneurysm coil embolization.
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Remifentanil 0.5-1 µg/kg IV administered over 90 seconds before endotracheal intubation.
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활성 비교기: Esmolol Group
Participants will receive esmolol 0.5-1 mg/kg intravenously over 90 seconds before endotracheal intubation during induction of general anesthesia for elective cerebral aneurysm coil embolization.
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Esmolol 0.5-1 mg/kg IV administered over 90 seconds before endotracheal intubation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in ONSD/ETD Ratio at 5 Minutes After Endotracheal Intubation
기간: 5 minutes after endotracheal intubation
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Difference between baseline (pre-intubation) and 5-minute post-intubation optic nerve sheath diameter-to-eyeball transverse diameter ratio (ONSD/ETD).
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5 minutes after endotracheal intubation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in ONSD/ETD Ratio at 10 Minutes After Endotracheal Intubation
기간: 10 minutes after endotracheal intubation
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Difference between baseline (pre-intubation) and 10-minute post-intubation optic nerve sheath diameter-to-eyeball transverse diameter ratio (ONSD/ETD).
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10 minutes after endotracheal intubation
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Change in Mean Arterial Pressure
기간: Baseline, 5 minutes, and 10 minutes after intubation
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Changes in mean arterial pressure measured before intubation, 5 minutes after intubation, and 10 minutes after intubation.
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Baseline, 5 minutes, and 10 minutes after intubation
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Change in Heart Rate
기간: Baseline, 5 minutes, and 10 minutes after intubation
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Changes in heart rate measured before intubation, 5 minutes after intubation, and 10 minutes after intubation.
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Baseline, 5 minutes, and 10 minutes after intubation
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Vasopressor Requirement
기간: From intubation until 10 minutes after intubation
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Requirement for vasopressor administration during the study period following endotracheal intubation.
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From intubation until 10 minutes after intubation
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Öner, Ö., & Yıldız, E. (2020). Comparison of The Effects of Remifentanil, Fentanyl, Esmolol, Lidocaine, and Amiodarone in Preventing Hemodynamic Response to Intubation. Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi Dergisi, 15(3), 22-29. https://doi.org/10.17517/ksutfd.673702
- Kim KH, Kang HK, Koo HW. Prediction of Intracranial Pressure in Patients with an Aneurysmal Subarachnoid Hemorrhage Using Optic Nerve Sheath Diameter via Explainable Predictive Modeling. J Clin Med. 2024 Apr 4;13(7):2107. doi: 10.3390/jcm13072107.
- Fu H, Hu J, Zhang X, Xie K, Hu L. Effect of different anesthesia strategies on intracranial pressure during extubation after intracranial aneurysm embolization: a randomized controlled trial. Sci Rep. 2026 Apr 18. doi: 10.1038/s41598-026-49045-6. Online ahead of print.
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
- ONSD/ETD
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
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. .
Remifentanil에 대한 임상 시험
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Medical University of ViennaVienna General Hospital; WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds알려지지 않은
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University General Hospital of Patras모병뇌허혈 | 케타민 | 황산마그네슘 | 레미펜타닐 | 세보플루란 마취 | 프로포폴/레미펜타닐 | S 100beta | S100 베타 단백질, 인간 | 뉴런-특이 적 에놀 라제그리스
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Harbin Medical UniversityFirst Affiliated Hospital of Harbin Medical University모병
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Fundación Universitaria de Ciencias de la SaludHospital de San Jose완전한
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Tongji Hospital완전한