IV hydrocortisone versus IV dexmedetomidine to prevent shivering after abdominal surgery
Comparative Study Between the Efficacy of Intravenous Hydrocortisone and Intravenous Dexmedetomidine for Prevention of Postoperative Shivering After General Anaesthesia for Abdominal Surgeries
This trial will test whether an IV dose of hydrocortisone or IV dexmedetomidine better prevents shivering after general anesthesia in adults having open abdominal surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07154849 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled Phase 4 trial at Ain Shams University in Cairo comparing two intravenous drugs given around the time of surgery to prevent postoperative shivering. Adult patients (18–65 years) with ASA I–II scheduled for open abdominal surgery lasting up to 120 minutes are randomized by simple randomization to receive hydrocortisone 2 mg/kg or dexmedetomidine 1 µg/kg. Standard intraoperative monitoring and perioperative care are provided and shivering incidence is recorded in the immediate postoperative period. Patients with significant endocrine, neurologic, psychiatric disease, pregnancy, lactation, long-term steroid use, or allergy to study drugs are excluded.
Who should consider this trial
Good fit: Adults aged 18–65 with ASA physical status I or II scheduled for open abdominal surgery under general anesthesia lasting ≤120 minutes and without exclusion conditions are ideal candidates.
Not a fit: Patients who are pregnant or lactating, on long-term steroids, have uncontrolled diabetes, thyroid disorders, neurologic or psychiatric illness, or who require procedures longer than 120 minutes are unlikely to qualify or benefit from this comparison.
Why it matters
Potential benefit: If successful, the best drug could reduce postoperative shivering and improve patient comfort and immediate recovery after abdominal anesthesia.
How similar studies have performed: Previous trials have shown dexmedetomidine reduces postoperative shivering, while use of systemic hydrocortisone for this purpose is less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: any patient undergoing abdominal surgery ASAI or II. \- Exclusion Criteria: * Patients with known neurologic and psychiatric illness. * Uncontrolled diabetic patients. * Patients on long term steroid therapy. * Allergy to any of the drugs used in the study. * Pregnancy and lactation. * Hypo or hyperthyroidism.
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: maha SMD elDerh, M.D.
- Email: mahasadek81@yahoo.com
- Phone: +20224190092
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.