Using Dexmedetomidine and Fentanyl to Prevent Shivering After Hip Surgery
A Comparative Study Between Dexmedetomidine and Fentanyl As Adjuvants to Hyperbaric Bupivacaine for the Prevention of Post-spinal Shivering in Hip Arthroplasty Surgeries
NA · Ain Shams University · NCT06834841
This study is testing whether adding dexmedetomidine or fentanyl to a common pain medication can help prevent shivering after hip surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06834841 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of intrathecal dexmedetomidine versus intrathecal fentanyl when added to hyperbaric bupivacaine for preventing post-spinal shivering in patients undergoing hip arthroplasty. Patients will be randomly assigned to one of two groups, receiving either dexmedetomidine or fentanyl, and will be monitored for sedation levels and the intensity of the spinal block. Preoperative assessments will include routine medical evaluations and informed consent. Intraoperative monitoring will ensure patient safety and efficacy of the interventions.
Who should consider this trial
Good fit: Ideal candidates are ASA I, II, or III patients over 20 years old scheduled for hip arthroplasty under spinal anaesthesia.
Not a fit: Patients with contraindications for spinal anaesthesia, known neurologic or psychiatric illnesses, or those under 150 cm in height may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-spinal shivering, improving patient comfort and recovery after hip arthroplasty.
How similar studies have performed: Other studies have shown promising results with similar approaches in managing post-operative complications, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I, ASA II or ASA III patients scheduled for hip arthroplasty surgeries under spinal anaesthesia. Age \> 20 years. Exclusion Criteria: * Patient refusal * Patients with known neurologic and psychiatric illness. * Contraindications for spinal anaesthesia as bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia. * Height \<150 cm. * Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency. * Allergy to any of the drugs used in the study.
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Rawan G Elsawah
- Email: emp14098@med.asu.edu.eg
- Phone: +201151051144
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: Post Spinal Shivering