Using tramadol and ketamine to prevent shivering after spinal anesthesia in cesarean sections
Randomised Double Blind Comparison of Prophylactic Tramadol and Tramadol Plus Ketamine for Prevention of Shivering After Spinal Anesthesia in Lower Segment Caeserian Section
PHASE4 · Ziauddin University · NCT06134895
This study is testing whether using tramadol alone or tramadol with ketamine can help prevent shivering in pregnant women having a cesarean section with spinal anesthesia.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Ziauddin University (other) |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT06134895 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of intravenous tramadol alone versus a combination of tramadol and ketamine in preventing shivering in patients undergoing lower segment cesarean sections with spinal anesthesia. It involves administering these medications prophylactically to assess their impact on shivering incidence. The study will include pregnant women aged 18 to 40 who are classified as American Society of Anesthesiologists physical status I and II. The outcomes will help determine the best approach to manage shivering in this specific surgical context.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 to 40 undergoing lower segment cesarean sections with spinal anesthesia.
Not a fit: Patients with hypertension, thyroid disorders, cardiopulmonary diseases, or elevated body temperatures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective method to reduce shivering in patients undergoing cesarean sections, enhancing patient comfort and recovery.
How similar studies have performed: While there is limited information on similar studies, the combination of tramadol and ketamine has shown promise in other contexts, suggesting potential for success in this application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 to 40 years * American Society of Anesthesiologist physical status I and II * Pregnant female for lower segment caeserian section Exclusion Criteria: * Patients with Hypertension * Patients with hypo- or hyperthyroidism * Known case of Cardiopulmonary disease, pre-eclampsia and eclampsia * An initial body temperature 38.00C or, 36.0oC assessed by thermometer
Where this trial is running
Karachi, Sindh
- Muhammad Arif — Karachi, Sindh, Pakistan (RECRUITING)
Study contacts
- Principal investigator: Muhammad Arif — Ziauddin University
- Study coordinator: Muhammad Arif
- Email: muhammad.aarif@zu.edu.pk
- Phone: +92 331 3455112
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.
Conditions: Shivering, Anesthesia, Spinal, Caesarean