An interventional study of Propofol and Sevoflurane plus lidocaine infusion in Sevoflurane, Lidocaine and Propofol, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
This study will be conducted to evaluate the effects of different anesthetic modalities [sevoflurane with or without intraoperative lidocaine infusion and Propofol total intravenous anesthesia (TIVA)] on intracranial pressure (ICP) and cerebral oxygenation assessed by non-invasive methods during laparoscopic hysterectomy (LH).
Laparoscopic hysterectomy (LH) requires a Trendelenburg position (TP) and the creation of an artificial pneumoperitoneum (PP) by carbon dioxide insufflation.
Various studies were done to evaluate the effects of different anesthesia techniques on intracranial pressure (ICP) during LH, and most of these studies revealed that propofol total intravenous anesthesia (TIVA) was superior to inhaled anesthesia regarding reduction of ICP (ONSD).
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Exclusion Criteria:
Patients' anesthesia will be maintained by manually adjusted propofol infusion at a rate of 100-250 mic/kg/min for bispectral index (BIS) maintained between 40-60.
Drug: Propofol
Sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60 plus intravenous lidocaine infusion given as 2mg /kg IV bolus before induction then intraoperative infusion by a rate of 2 mg/kg/h until the end of surgery.
Drug: Sevoflurane plus lidocaine infusion
Patients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60.
Drug: Sevoflurane
Patients' anesthesia will be maintained by manually adjusted propofol infusion at a rate of 100-250 mic/kg/min for bispectral index (BIS) maintained between 40-60.
Sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60 plus intravenous lidocaine infusion given as 2mg /kg IV bolus before induction then intraoperative infusion by a rate of 2 mg/kg/h until the end of surgery.
Patients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60.
Optic nerve sheath diameter
Optic nerve sheath diameter of both eyes is expressed in millimeters and will be assessed at times of: T0; baseline before induction, T1; after insertion of endotracheal tube, T2; just before pneumoperitoneum (PP), T3;30 minutes after PP and Trendelenburg position (TP),T4; 60 minutes after PP and TP,T5; Five minutes after disinflation of PP and T6;after extubating the endotracheal tube.
Time frame: After extubating the endotracheal tube (up to one hour)
Cerebral oxygenation
Cerebral oxygenation of both hemispheres by near-infrared spectroscopy (NIRS). normal values 60-70% and will be assessed at times of: T0; baseline before induction, T1; after insertion of endotracheal tube, T2; just before pneumoperitoneum (PP), T3;30 minutes after PP and Trendelenburg position (TP), T4; 60 minutes after PP and TP, T5; Five minutes after disinflation of PP and T6; after extubating the endotracheal tube.
Time frame: After extubating the endotracheal tube (up to one hour)
Cognitive function
Cognitive function by standardized mini mental state examination (SMMSE) preoperative, and 4hours postoperatively.
Time frame: 4 hours postoperatively
Incidence of postoperative complications
Incidence of postoperative complications such as hypotension, bradycardia, postoperative nausea and vomiting (PONV), and headache will be recorded.
Time frame: 24 hours postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
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Tanta University