Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries: A Randomized Controlled Trial
Shivering is a common and distressing complication following spinal anesthesia, affecting up to 70% of patients. It significantly increases oxygen consumption, places stress on the cardiovascular system, and interferes with postoperative monitoring. While intravenous paracetamol has been shown to reduce post-spinal shivering without the sedation or respiratory side effects associated with other medications, existing trials have only investigated a standard 1-gram dose. This study aims to evaluate whether a higher dose of intravenous paracetamol (2 grams) provides superior prevention of post-spinal shivering compared to the standard 1-gram dose and an inactive placebo.
Adult patients scheduled for elective lower-limb orthopedic surgery under spinal anesthesia will be randomly allocated to one of three study groups:
- High-dose group: intravenous paracetamol 2 g
- Standard-dose group: intravenous paracetamol 1 g
- Control group: intravenous normal saline placebo
Each infusion will be administered over 15 minutes immediately prior to spinal anesthesia. Participants will be observed intraoperatively and for at least 60 minutes in the post-anesthesia care unit (PACU) to measure the incidence and severity of shivering, core body temperature changes, the need for rescue medication, and any adverse events.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 4단계
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18 to 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective lower-limb orthopedic surgery under spinal anesthesia
- Expected surgical duration between 1 and 3 hours
- Willingness to provide written informed consent
Exclusion Criteria:
- Patient refusal or inability to provide informed consent
- ASA physical status >= III
- Contraindications to spinal anesthesia (e.g., coagulopathy, local infection at injection site, severe spinal deformity)
- Known allergy or hypersensitivity to paracetamol or the local anesthetic used
- Baseline (preoperative) core/tympanic temperature < 36.5°C or > 37.5°C
- Pre-existing hepatic, renal, or thyroid disorders
- History of seizure disorder
- Chronic alcohol use, malnutrition, or any condition predisposing to hepatotoxicity
- Body mass index (BMI) > 35 kg/m²
- Pregnancy or lactation
- Chronic use of antipyretic or anti-inflammatory medication within 24 hours of surgery
- Cardiac arrhythmia or hemodynamic instability
공부 계획
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디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Group H: High-Dose Paracetamol (2 g)
Patients receive intravenous paracetamol 2 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection. |
Intravenous paracetamol 2 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection. |
|
활성 비교기: Group S: Standard-Dose Paracetamol (1 g)
Patients receive intravenous paracetamol 1 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection. |
Intravenous paracetamol 1 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection. |
|
위약 비교기: Group C: Placebo Control
Patients receive 500 mL of intravenous normal saline (0.9% sodium chloride), infused over 15 minutes, commencing immediately prior to intrathecal injection. |
Intravenous 0.9% normal saline 500 mL, infused over 15 minutes immediately prior to intrathecal injection, matched in volume and appearance to preserve blinding. |
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주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants With Clinically Significant Post-Spinal Shivering
기간: Up to 4 hours post-spinal injection
|
Clinically significant shivering is defined as a shivering score >= 3 on the Crossley and Mahajan Shivering Grading Scale. The scale ranges from Grade 0 to Grade 4: Grade 0 = No shivering; Grade 1 = Piloerection or peripheral vasoconstriction without visible muscular activity; Grade 2 = Muscular activity confined to one muscle group; Grade 3 = Muscular activity involving more than one muscle group, but not generalized; Grade 4 = Gross muscular activity involving the whole body. Higher grades indicate greater shivering severity. |
Up to 4 hours post-spinal injection
|
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연구 주요 날짜
연구 시작 (추정된)
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기본 완료 (추정된)
기본 완료
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최초 제출
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기타 연구 ID 번호
기타 연구 ID 번호
- Paracetamol Dose for Shivering
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