Comparing opioid-free anesthesia to opioid anesthesia for brain tumor surgery
A Comparative Study Between Opioids Free Anesthesia Using Dexmedetomidine and Lidocaine and Conventional Opioid Anesthesia on Stress Points Haemodynamics in Patients Undergoing Supratentorial Tumor Resection
This study is testing whether using anesthesia without opioids can help people having brain tumor surgery recover better and have fewer complications than those using traditional opioid anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06791811 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of opioid-free anesthesia (OFA) compared to traditional opioid anesthesia (OA) in patients undergoing resection of supratentorial tumors. The research aims to address concerns related to postoperative complications associated with opioid use, such as hyperalgesia and impaired healing. By utilizing alternative anesthetic techniques, the study seeks to improve patient outcomes during and after surgery. The trial will include patients aged 18-50 who meet specific health criteria and will assess the impact of anesthesia type on hemodynamic stability and recovery.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-50 with ASA I and II classifications undergoing supratentorial tumor resection.
Not a fit: Patients with significant comorbidities, such as uncontrolled hypertension or cardiac arrhythmias, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer anesthesia practices that reduce postoperative complications and improve recovery for patients undergoing brain surgery.
How similar studies have performed: Other studies have shown promising results with opioid-free anesthesia approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ASA Ι and II. 2. Patients undergoing resection of supratentorial tumors in supine position. 3. Age (18-50) years. 4. Both sexes. Exclusion Criteria: 1. Impaired renal functions. 2. Uncontrolled systemic hypertension(patients with sustained elevated blood pressure more than 140/90). 3. Cardiac arrhythmias (any rhythm other than normal sinus rhythm and sinus tachycardia). 4. Heart failure(impaired cardiac contractility ,EF less than 45%.). 5. Patients receiving more than 2 units of blood during surgery. 6. Patients with large masses and expected severe increase in ICP. 7. Patients requiring vasopressors infusion. 8. The need for postoperative ventilation at the end of study. 9. Glasgow coma scale less than 14. 10. History of allergy to the study drugs. 11. Surgeries lasting more than 4 hours. 12. Pregnancy. 13. Bronchial asthma.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Sherif A Embaby, Consultant
- Email: Sherif.embaby@kasralainy.edu.eg
- Phone: +20 1003852294
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.