- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05279703
Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery
The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial
Maternal hypotension after spinal block is a common complication after subarachnoid block in this population. The incidence of maternal hypotension is nearly 60% when prophylactic vasopressors are not used. Therefore, it is highly recommended to use vasopressors, preferably as continuous infusion, for prophylaxis rather than delaying their use until hypotension occurs.
Phenylephrine (PE) is the recommended drug for prophylaxis against hypotension during cesarean delivery; however, the use of PE is commonly associated with decreased heart rate and probably cardiac output because PE is a pure alpha adrenoreceptor agonist. Introduction of NE in obstetric practice had shown favorable maternal and neonatal outcomes and was associated with higher heart rate and cardiac output compared to PE. However, there is still some mothers who develop bradycardia and diminished cardiac output with the use of NE. The most desired scenario during hemodynamic management of mothers during cesarean delivery would achieve the least possible incidences of maternal hypotension, bradycardia and reactive hypertension. Therefore, it is warranted to reach a vasopressor regimen with the most stable hemodynamic profile.
In the last year, epinephrine was reported for the first time in obstetric practice with acceptable safety on the mother and the fetus. However, there is still lack of data about the most appropriate dose for infusion during cesarean delivery. This study aims to compare three prophylactic infusion rates for epinephrine during cesarean delivery.
연구 개요
상태
상세 설명
Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.
Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.
After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and the vasopressor infusion will be started.
- 0.01 mcg group
- 0.02 mcg group
- 0.03 mcg group The vasopressor infusion will be through the same line as the fluid a three-way stopcock. The vasopressor infusion will be stopped if heart rate became ≥130% of baseline or systolic blood pressure ≥120% of baseline, otherwise the infusion will be stopped 5 minutes after delivery of the baby.
Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.
Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration of 9 mg of ephedrine Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration IV ephedrine 15 mg.
Reactive hypertension (defined as systolic blood pressure ≥120% of the baseline reading) will be managed by stoppage of the infusion till the next systolic blood pressure reading. The infusion will be then re-started at the half of the initial rate, when systolic blood pressure decreases to be within 20% of the baseline reading.
Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered.
Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (0.5 IU) will be delivered over five seconds after delivery the infused at a rate of 2.5 IU/hour.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Ahmed Hasanin
- 전화번호: 01095076954
- 이메일: ahmedmohamedhasanin@gmail.com
연구 장소
-
-
-
Cairo, 이집트, 11562
- 모병
- Kasr Alaini hospital
-
연락하다:
- Anesthesia, Pain Management and Surgical ICU Department
- 전화번호: 00201222224057
- 이메일: Anesthesia.kasralainy@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- full-term singleton pregnant women
- American society of anesthesiologist-physical status I or II,
- scheduled for elective cesarean delivery
Exclusion Criteria:
- Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
- hypertensive disorders of pregnancy,
- peripartum bleeding,
- coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or
- any contraindication to regional anesthesia,
- and baseline systolic blood pressure (SBP) < 100 mmHg
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 0.03 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
|
epinephrine infusion rate of 0.03 mcg/kg/min
다른 이름들:
|
|
활성 비교기: 0.02 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
|
epinephrine infusion rate of 0.02 mcg/kg/min
다른 이름들:
|
|
활성 비교기: 0.01 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
|
epinephrine infusion rate of 0.01 mcg/kg/min
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
incidence of postspinal hypotension
기간: 1 minute after subarachnoid injection till 5 minutes after baby delivery
|
systolic blood pressure ≤80% of the baseline reading
|
1 minute after subarachnoid injection till 5 minutes after baby delivery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
incidence of tachycardia
기간: 1 minute after subarachnoid injection till 5 minutes after baby delivery
|
heart rate > 130% of baseline
|
1 minute after subarachnoid injection till 5 minutes after baby delivery
|
|
incidence of hypertension
기간: 1 minute after subarachnoid injection till 5 minutes after baby delivery
|
systolic blood pressure >120% of baseline
|
1 minute after subarachnoid injection till 5 minutes after baby delivery
|
|
incidence of severe hypotension
기간: 1 minute after subarachnoid injection till 5 minutes after baby delivery
|
systolic blood pressure ≤60% of the baseline reading
|
1 minute after subarachnoid injection till 5 minutes after baby delivery
|
|
mean heart rate
기간: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
|
beat per minute
|
1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
|
|
mean systolic blood pressure
기간: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
|
mmHg
|
1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
|
|
total ephedrine requirement
기간: 1 minute after subarachnoid injection till 5 minutes after baby delivery
|
mg
|
1 minute after subarachnoid injection till 5 minutes after baby delivery
|
|
total atropine requirement
기간: 1 minute after subarachnoid injection till 5 minutes after baby delivery
|
mg
|
1 minute after subarachnoid injection till 5 minutes after baby delivery
|
|
Apgar score
기간: 5 minutes after delivery
|
Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition
|
5 minutes after delivery
|
|
umbilical blood pH
기간: 5 minutes after delivery
|
pH
|
5 minutes after delivery
|
|
umbilical blood PCO2
기간: 5 minutes after delivery
|
mmHg
|
5 minutes after delivery
|
|
umbilical blood PO2
기간: 5 minutes after delivery
|
mmHg
|
5 minutes after delivery
|
|
umbilical blood HCO3
기간: 5 minutes after delivery
|
mmol/L
|
5 minutes after delivery
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
- MD-399-2021
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. .