Actively Recruiting
Comparison of Prophylactic Intravenous Pethidine Versus Intrathecal Pethidine in Preventing Post Spinal Shivering in Caesarean Section
Led by Alexandria University · Updated on 2025-01-15
86
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial focuses on females aged 20 to 40 years undergoing elective cesarean section under spinal anesthesia. It aims to compare two ways of giving pethidine—intravenous (IV) and intrathecal—to see which is better at preventing shivering after spinal anesthesia. Researchers also want to learn how these methods affect heart and blood pressure stability, nausea, vomiting, and sedation. Participants are randomly assigned to one of two groups. One group receives IV pethidine at 0.5 mg/kg mixed in saline before surgery, while the other receives 0.2 mg/kg pethidine injected into the spinal area along with bupivacaine. Spinal anesthesia will be administered using a needle between the lower back vertebrae. Patients will not be actively warmed during surgery, and medications like ephedrine and atropine will be given if blood pressure or heart rate drop. Room temperature will be controlled during the operation and recovery. Throughout the surgery and recovery, participants will be closely monitored for shivering using a standardized scale every 15 to 30 minutes. Vital signs like heart rate and blood pressure will be checked regularly, along with body temperature. Researchers will also record any nausea, vomiting, or sedation. The main outcomes measured are the frequency, start time, length, and severity of shivering. Secondary outcomes include heart and blood pressure stability and side effects. Monitoring continues for the first two hours after surgery.
CONDITIONS
Brief 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
- Undergoing elective cesarean section with spinal anesthesia
- American Society of Anesthesiologists physical status II
- Able to provide written informed consent
You will not qualify if you...
- Contraindications to spinal anesthesia
- Uncontrolled hypertension, diabetes mellitus, liver, lung, or thyroid diseases
- Obesity with body mass index greater than 35
- Known allergy to study drugs
- Body temperature below 36 or above 37.5 degrees Celsius
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the cesarean section procedure and immediate postoperative period
Participants receive either intravenous or intrathecal pethidine during spinal anesthesia for elective cesarean section to prevent post-spinal shivering.
1 surgical visit and continuous monitoring during surgery and 2 hours postoperatively
Duration - 2 hours postoperatively
Participants are monitored for shivering, vital signs, body temperature, and possible drug-related complications for 2 hours after surgery.
Monitoring visits every 15 to 30 minutes during and after surgery for up to 2 hours
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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