Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section
Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section: A Comparative Study
Spinal anesthesia is widely used for cesarean deliveries, but shivering is a frequent complication that occurs in 40% to 60% of patients. Post-spinal shivering can cause maternal discomfort, increase oxygen consumption and metabolic demands, and interfere with clinical monitoring. Both paracetamol and magnesium sulfate have thermoregulatory properties that may prevent or reduce shivering.
The purpose of this clinical trial is to compare the efficacy and safety of intravenous paracetamol versus intravenous magnesium sulfate in preventing and reducing shivering following spinal anesthesia in women undergoing elective cesarean section.
A total of 90 pregnant women scheduled for elective cesarean delivery will be randomly assigned to one of two groups:
- Group P (Paracetamol Group): Participants receive intravenous paracetamol (15 mg/kg) infused over 15 minutes immediately following the subarachnoid block.
- Group M (Magnesium Sulfate Group): Participants receive intravenous magnesium sulfate (30 mg/kg) administered immediately following the subarachnoid block.
The primary outcome evaluated is the severity of post-spinal shivering assessed by shivering scores. Secondary outcomes include hemodynamic parameters (heart rate, blood pressure, oxygen saturation), postoperative pain, complications such as nausea and vomiting, and maternal satisfaction.
연구 개요
연구 유형
등록 (추정된)
단계
- 4단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status class I or II
- Pregnant women aged 20 to 40 years
- Term gestation (>= 37 weeks) with an uncomplicated pregnancy
- Scheduled for elective cesarean delivery under planned spinal anesthesia
- Patient agreement and signed written informed consent
Exclusion Criteria:
- Patient refusal
- Morbid obesity (BMI > 35 kg/m²)
- Contraindications to spinal anesthesia
- Significant organ dysfunction (e.g., cardiac, respiratory, renal, or hepatic disorders)
- Known hypersensitivity or allergy to paracetamol or magnesium sulfate
- Cardiovascular or neuromuscular disorders in which magnesium administration is contraindicated
- Emergency cesarean section
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 |
|---|---|
|
활성 비교기: Group P: Paracetamol Group
Participants receive intravenous paracetamol at a dose of 15 mg/kg infused over 15 minutes immediately after the completion of the subarachnoid block. |
Administered intravenously at a dose of 15 mg/kg infused over 15 minutes immediately after the completion of the subarachnoid block. |
|
활성 비교기: Group M: Magnesium Sulfate Group
Participants receive intravenous magnesium sulfate at a dose of 30 mg/kg administered immediately after the completion of the subarachnoid block. |
Administered intravenously at a dose of 30 mg/kg immediately after the completion of the subarachnoid block. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Post-Spinal Shivering Score
기간: Up to 2 hours postoperatively
|
Post-spinal shivering severity is assessed using a 5-point shivering scale where Grade 0 indicates no shivering; Grade 1 indicates piloerection or peripheral vasoconstriction without visible shivering; Grade 2 indicates muscular activity in only one muscle group; Grade 3 indicates muscular activity in more than one muscle group, but not generalized; and Grade 4 indicates generalized, whole-body shivering. Total scores range from 0 to 4, with higher scores representing greater shivering severity |
Up to 2 hours postoperatively
|
공동 작업자 및 조사자
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
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