Comparison of Norepinehrine Versus Phenylepherine Infusion for Prevention of Post-spinal Hypotension
Comparison of Norepinephrine Versus Phenylephrine Infusion for Prevention of Hypotension Due to Subarachnoid Block in Elderly Patients Undergoing Orthopedic Hip Surgery:A Prospective Randomized Trial
연구 개요
상태
정황
상세 설명
Spinal anesthesia-induced hypotension is a common and clinically significant complication in elderly patients undergoing orthopedic hip surgery. Age-related physiological changes, impaired autonomic responses, and reduced cardiovascular reserve increase susceptibility to hypotension after subarachnoid block, which may result in organ hypoperfusion, myocardial ischemia, nausea, vomiting, and increased perioperative morbidity.
Phenylephrine is traditionally used for prevention and treatment of spinal anesthesia-induced hypotension because of its potent alpha-adrenergic vasoconstrictive effect. However, its use may be associated with reflex bradycardia and reduction in cardiac output. Norepinephrine, which possesses both alpha-adrenergic and mild beta-adrenergic activity, may provide better maintenance of heart rate and cardiac output while effectively preserving blood pressure.
This prospective randomized double-blinded clinical trial will be conducted at the Department of Anesthesia, Intensive Care and Pain Management, Sohag University Hospitals, after approval from the Institutional Ethics Committee. Elderly patients aged 60 years or older, classified as ASA physical status I-III and scheduled for elective orthopedic hip surgery under spinal anesthesia, will be enrolled after obtaining written informed consent.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Ahmed Abdelhamed Faress, Resident
- 전화번호: 01065080913
- 이메일: drahmedfaress23896@gmail.com
연구 연락처 백업
- 이름: Fawzy Abbas Badawy, Professor
연구 장소
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Sohag, 이집트
- 모병
- Sohag University Hospital
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연락하다:
- Mohamed N Hamdoun, Professor
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 60 years or older.
- ASA physical status I-III.
- Scheduled for elective hip surgery under subarachnoid block.
- Willing to provide written informed consent.
Exclusion Criteria:
- Patient refusal.
- Contraindications to subarachnoid block.
- Severe cardiac disease.
- Uncontrolled hypertension.
- Allergy to study drugs.
- Emergency surgery.
- Monoamine oxidase inhibitor use.
- Cognitive impairment preventing informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Norepinehrine group
• NE group: norepinephrine infusion at 8 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
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norepinephrine infusion at 8 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
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실험적: Phenylepherine group
PhE group: phenylephrine infusion at 100 µg/min Infusion will continue for 45 minutes after spinal anesthesia.
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phenylephrine infusion at 100 µg/min.
Infusion will continue for 45 minutes after spinal anesthesia.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean intaroperative heart rate (beats /minute) during vasopressor infusion measured by continous electrocardiogrammonitoring
기간: From the start of subarachnoid block until the end of surgery .
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Heart rate will be continously monitored using standar electrocardiogram monitoring.
to compare the effect of norepinephrine versus phenylephrine infusion on hemodynamics.
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From the start of subarachnoid block until the end of surgery .
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of spinal anesthesia-induced hypotension
기간: From the administration of spinal anesthesia until the end of the procedure.
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Defined as a decrease in mean arterial pressure (MAP) to <80% of baseline measurd by non-invasive blood pressure monitoring .
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From the administration of spinal anesthesia until the end of the procedure.
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Incidence of bradycardia
기간: Throughout the intraoperative period
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Defined as heart rate ≤ 50 beats/min.
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Throughout the intraoperative period
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Mean arterial pressure (MAP) trends measured using non-invasive blood pressure monitoring
기간: Every 5 minutes from the start of spinal anesthesia until the end of surgery.
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Monitoring the stability of blood pressure during vasopressor infusion
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Every 5 minutes from the start of spinal anesthesia until the end of surgery.
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Incidence of reactive hypertension measured by non-invasive blood pressure monitoring
기간: From the start of vasopressor infusion until the end of surgery.
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Defined as mean arterial pressure (MAP) > 125% of baseline.
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From the start of vasopressor infusion until the end of surgery.
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Total intraoperative intavenous fluid
기간: At the end of the surgical procedure.
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Total volume of intravenous fluids administered in milliliters
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At the end of the surgical procedure.
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
- Soh-Med-26-5-9MS
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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Norepinephrine에 대한 임상 시험
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