Sevoflurane (with or without IV lidocaine) versus propofol for intracranial pressure and brain oxygen during laparoscopic hysterectomy
Effect of Sevoflurane With or Without Intravenous Lidocaine Infusion Versus Propofol Anesthesia on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Hysterectomy: A Randomized Controlled Study
This study will test whether sevoflurane (with or without an IV lidocaine infusion) or propofol anesthesia better controls intracranial pressure and cerebral oxygenation in adult women having laparoscopic hysterectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT07062367 on ClinicalTrials.gov |
What this trial studies
Participants undergoing laparoscopic hysterectomy will receive either propofol total intravenous anesthesia, sevoflurane inhalational anesthesia, or sevoflurane with an intraoperative IV lidocaine infusion. Intracranial pressure will be estimated noninvasively using optic nerve sheath diameter and cerebral oxygenation will be monitored with cerebral oximetry at baseline, during pneumoperitoneum and Trendelenburg positioning, and after surgery. The trial compares perioperative changes in these measures across the three anesthetic approaches to determine which minimizes intracranial pressure increases and preserves cerebral oxygen delivery. All procedures and monitoring are performed at a single center with adult women meeting ASA I–II and BMI eligibility criteria.
Who should consider this trial
Good fit: Adult women aged 18–65, ASA physical status I–II, BMI ≤35, scheduled for laparoscopic hysterectomy and without significant neurologic, cardiovascular, hepatic, renal, or ophthalmic disease would be eligible.
Not a fit: Patients with pre-existing central nervous system or cardiovascular disease, severe hepatic or renal impairment, ophthalmic conditions preventing optic nerve sheath diameter measurement, or those who convert to open surgery or develop excessive peak inspiratory pressures are unlikely to be helped or included.
Why it matters
Potential benefit: If successful, the results could identify an anesthesia approach that reduces intracranial pressure spikes and preserves brain oxygenation during laparoscopic hysterectomy, improving perioperative safety.
How similar studies have performed: Previous studies have generally shown propofol TIVA reduces intracranial pressure more than inhaled anesthetics, while the added effect of intraoperative lidocaine on these measures is less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 65 years. * American Society of Anesthesiologists (ASA) physical status I and Ⅱ. * Body mass index (BMI) ≤35. * Females scheduled for laparoscopic hysterectomy. Exclusion Criteria: * Patients' refusal to participate in the study. * Hypersensitivity and allergy to drugs of the study. * Contraindication for optic nerve sheath diameter assessment. E.g., patient with pre-existing ophthalmic diseases, a history of ophthalmic surgery * Any central nervous system or cardiovascular disease, severe hepatic or renal impairment * Intraoperative circumstances, such as inability to perform optic nerve sheath diameter or conversion to open surgery * If peak inspiratory pressure (PIP) exceeds 35.
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Eman A Elrefaey, Master
- Email: eman.elrefaey@med.tanta.edu.eg
- Phone: 00201008031402
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.