NCT06775431 Comparing Prophylactic Intravenous Pethidine and Intrathecal Pethidine in Preventing Post Spinal Shivering in Caesarean Section
| NCT ID | NCT06775431 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alexandria University |
| Condition | Pregnant Women |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 86 participants in total. It began in 2024-12-10 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to assess the effect of IV pethidine and intrathecal pethidine on the incidence, onset, duration, and intensity of shivering in females undergoing caesarean section. The main question it aims to answer is: which route is more efficacious in preventing shivering. Researchers will compare IV pethidine and intrathecal pethidine to see their effects on post spinal shivering, their effects on hemodynamic stability, nausea, vomiting, and sedation.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06775431 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 40 Years, studying Pregnant Women. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06775431 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 86 participants.
Is NCT06775431 currently recruiting?
Yes, NCT06775431 is actively recruiting participants. Contact the research team at m_mohamed165@alexmed.edu.eg for enrollment information.
Where is the NCT06775431 trial being conducted?
This trial is being conducted at Alexandria, Egypt.
Who is sponsoring the NCT06775431 clinical trial?
NCT06775431 is sponsored by Alexandria University. The trial plans to enroll 86 participants.