Actively Recruiting
Comparison of Intravenous Versus Intrathecal Pethidine to Prevent Shivering After Spinal Anesthesia in Caesarean Section
Led by Alexandria University · Updated on 2025-01-15
86
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of intravenous (IV) pethidine and intrathecal pethidine on shivering in females undergoing cesarean section under spinal anesthesia. The study focuses on how these two drug administration routes influence the occurrence, start time, duration, and severity of shivering. It also evaluates their impact on hemodynamic stability, nausea, vomiting, and sedation in this patient group. The study is a single-blinded, randomized, phase 3 trial involving 86 women aged 20 to 40 years old with physical status ASA II, scheduled for elective cesarean section. Participants will be randomly assigned to one of two groups: one receiving IV pethidine 0.5 mg/kg mixed in saline before surgery, and the other receiving intrathecal pethidine 0.2 mg/kg combined with bupivacaine 0.5% during spinal anesthesia. Spinal anesthesia will be performed at the L3-L4 or L4-L5 level, and patients will not be actively warmed during surgery. Standard protocols will manage hypotension, bradycardia, and vomiting if they occur. Throughout the surgery and for two hours after, vital signs and body temperature will be regularly monitored, and shivering will be assessed every 15 minutes during surgery and every 30 minutes postoperatively using the Tsai and Chu Scale. Researchers will record the frequency, timing, length, and intensity of shivering, along with any side effects like nausea, vomiting, and sedation. The operating room and recovery area temperatures will be maintained between 21 and 24 degrees Celsius to control environmental factors.
CONDITIONS
Official Title
Comparing Prophylactic Intravenous Pethidine and Intrathecal Pethidine in Preventing Post Spinal Shivering in Caesarean Section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 20 to 40 years
- American Society of Anesthesiologists physical status II
- Undergoing elective cesarean section with spinal anesthesia
You will not qualify if you...
- Contraindications to spinal anesthesia
- Uncontrolled hypertension, diabetes mellitus, liver, lung, or thyroid diseases
- Obesity with BMI greater than 35
- Known drug allergy
- Body temperature below 36 or above 37.5 degrees Celsius
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Trial Site Locations
Total: 1 location
1
El-Shatby University Hospital
Alexandria, Alexandria Governorate, Egypt
Actively Recruiting
Research Team
M
Mai A El-Sayed, Lecturer of Anesthesia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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