Comparing two methods of administering pethidine to prevent shivering after cesarean section
Comparison of Prophylactic Intravenous Pethidine Versus Intrathecal Pethidine in Preventing Post Spinal Shivering in Caesarean Section
This study is testing whether giving pethidine through an IV or directly into the spine can help prevent shivering in women having a cesarean section.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria, Alexandria Governorate) |
| Trial ID | NCT06775431 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intravenous (IV) pethidine versus intrathecal pethidine in preventing post-spinal shivering in women undergoing elective cesarean sections. The study will involve 86 patients who will be randomly assigned to receive either IV pethidine or intrathecal pethidine, with their shivering incidence, onset, duration, and intensity being monitored. The trial will also assess the impact of these interventions on hemodynamic stability, nausea, vomiting, and sedation levels. The study will be conducted at El-Shatby University Hospital, ensuring a controlled environment for accurate results.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 20-40 years old, classified as American Society of Anesthesiologists physical status II, who are undergoing elective cesarean sections.
Not a fit: Patients with contraindications to spinal anesthesia, uncontrolled medical conditions, obesity, drug allergies, or abnormal body temperatures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective method for preventing post-spinal shivering in cesarean section patients, enhancing their comfort and recovery.
How similar studies have performed: While there have been studies on pethidine administration, this specific comparison of IV versus intrathecal routes for preventing post-spinal shivering is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Exclusion Criteria: 1. contraindications to spinal 2. uncontrolled hypertension, diabetes mellitus, hepatic, pulmonary diseases, and thyroid disease 3. obesity (BMI \>35) 4. drug allergy 5. temperature below 36 degrees celcius or above 37.5 degrees celcius
Where this trial is running
Alexandria, Alexandria Governorate
- El-Shatby University Hospital — Alexandria, Alexandria Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Mai A El-Sayed, Lecturer of Anesthesia
- Email: m_mohamed165@alexmed.edu.eg
- Phone: 00201287459922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.