Actively Recruiting

Phase 3
Age: 20Years - 40Years
FEMALE
ID06775431

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

Age: 20Years - 40Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

El-Shatby University Hospital

Alexandria, Alexandria Governorate, Egypt

Actively Recruiting

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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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Comparison of Intravenous Versus Intrathecal Pethidine to Prevent Shivering After Spinal Anesthesia in Caesarean Section | DecenTrialz