A Comparative Study Between Opioids Free Anesthesia and Opioid Anesthesia in Patients with Supratentorial Tumor Resection
Launched by KASR EL AINI HOSPITAL · Jan 19, 2025
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of two different types of anesthesia for patients undergoing surgery to remove brain tumors located above the tentorium (a part of the brain). The trial compares traditional opioid anesthesia, which uses strong pain medications like fentanyl, with opioid-free anesthesia (OFA), which uses a combination of other medications to manage pain without opioids. Researchers want to see if OFA can provide effective pain relief while also improving recovery times and reducing side effects like nausea and the need for additional pain medications after surgery.
To be eligible for this trial, participants should be between 18 and 50 years old and in good health, classified as ASA I or II (which means they have no serious health issues). They must be undergoing surgery to remove a supratentorial tumor while lying on their back. However, individuals with certain health conditions, such as uncontrolled high blood pressure, heart problems, or those who are pregnant, cannot participate. If you join the trial, you can expect to receive either type of anesthesia during your surgery and be monitored closely by medical staff. This trial aims to find safer and more effective anesthesia options for brain surgery, which could benefit many patients in the future.
Gender
ALL
Eligibility 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.
About Kasr El Aini Hospital
Kasr El Aini Hospital, a prestigious medical institution affiliated with Cairo University, is dedicated to advancing healthcare through innovative clinical research. With a commitment to excellence, the hospital serves as a leading sponsor of clinical trials, leveraging its state-of-the-art facilities and a multidisciplinary team of healthcare professionals. The institution focuses on a diverse range of therapeutic areas, aiming to improve patient outcomes and contribute to the global medical community. By fostering collaboration and adhering to the highest ethical standards, Kasr El Aini Hospital plays a pivotal role in the development of new treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cairo, Giza, Egypt
Patients applied
Trial Officials
Rania Samir, professor
Study Director
Department of anaesthesia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported