Dexamethasone to Prevent Side Effects of Spinal Anesthesia in Cesarean Delivery
Evaluation of the Effectiveness of Intravenous Dexamethasone in Preventing Adverse Effects of Spinal Anesthesia in Parturients Undergoing Cesarean Delivery
The goal of this clinical trial is to evaluate the effectiveness of intravenous dexamethasone in preventing adverse effects of spinal anesthesia and prolonging postoperative analgesia in parturients undergoing elective cesarean delivery.
The main questions it aims to answer are:
Does intravenous dexamethasone reduce the incidence of post-spinal hypotension?
Does intravenous dexamethasone reduce the incidence of postoperative nausea and vomiting (PONV)?
Does intravenous dexamethasone prolong the duration of postoperative analgesia?
Researchers will compare intravenous dexamethasone (8 mg) to a placebo (0.9% saline) to see if dexamethasone effectively prevents post-spinal hypotension and PONV, and improves postoperative pain relief.
Participants will:
Receive an intravenous injection of either 8 mg dexamethasone or a placebo (2 mL 0.9% saline) prior to receiving spinal anesthesia.
Have their blood pressure recorded frequently (every minute for the first 20 minutes, then every 5 minutes until the completion of surgery).
Undergo sensory block assessment (via cold testing) and motor block evaluation (using the Bromage scale).
Have maternal glycemia and neonatal safety monitored for potential steroid-related adverse effects.
연구 개요
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 장소
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Ho Chi Minh
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Ho Chi Minh City, Ho Chi Minh, 베트남, 700000
- University Medical Center Ho Chi Minh City (UMC) - Campus 2
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age ≥ 18 years
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- American Society of Anesthesiologists (ASA) physical status classification of II-III
- Planned for elective cesarean delivery under spinal anesthesia
Exclusion Criteria:
- Gestational diabetes mellitus or pre-existing (chronic) diabetes mellitus
- Gestational hypertension or chronic hypertension
- Body mass index (BMI) ≥ 35 kg/m²
- Known allergy to dexamethasone
- Current long-term corticosteroid therapy
- Diagnosis of postpartum hemorrhage
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 위약
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Intravenous administration of 2 mL of 0.9% normal saline as a placebo immediately before the induction of spinal anesthesia.
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실험적: 덱사메타손
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Intravenous administration of 8 mg dexamethasone immediately before the induction of spinal anesthesia.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Post-Spinal Hypotension
기간: From the induction of spinal anesthesia until the completion of surgery
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The number of participants experiencing at least one episode of post-spinal hypotension.
Hypotension is defined as a decrease in systolic blood pressure of 20% or more from the baseline value.
Baseline blood pressure is defined as the mean value of three consecutive measurements taken 2 minutes apart, with a variation of less than 10%.
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate are recorded every minute for the first 20 minutes after spinal anesthesia, and then every 5 minutes until the completion of surgery and transfer to the post-anesthesia care unit
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From the induction of spinal anesthesia until the completion of surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Postoperative Nausea and Vomiting (PONV)
기간: From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours)
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The number of participants experiencing nausea, vomiting, or retching, or requiring rescue antiemetic treatment.
Rescue treatment is administered as intravenous ondansetron 4 mg or intravenous metoclopramide 10 mg.
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From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours)
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Duration of Postoperative Analgesia
기간: From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)
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The time elapsed from the administration of spinal anesthesia to the patient's first request for systemic rescue analgesic medication.
Rescue analgesia is administered when the patient complains of pain and records a Visual Analog Scale (VAS) score greater than 4 (on a scale of 0 to 10).
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From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)
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공동 작업자 및 조사자
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
- 4667/UMP-BOARD
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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-
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