Sevoflurane With or Without Intravenous Lidocaine Infusion Versus Propofol Anesthesia on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Hysterectomy

Not Applicable

Recruiting

• Conditions: Sevoflurane; Propofol; Intracranial Pressure; Lidocaine; Cerebral Oxygenation; Laparoscopic Hysterectomy
• Interventions: Drug: Propofol; Drug: Sevoflurane plus lidocaine infusion; Drug: Sevoflurane

• Registration Number: NCT07062367
• Lead Sponsor: Tanta University

Brief Summary

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).

Detailed Description

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).

Study Timeline

• Study Start: 2025-02-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol group	Propofol	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 plus lidocaine infusion group	Sevoflurane plus lidocaine infusion	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.
Sevoflurane group	Sevoflurane	Patients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60.

Primary Outcome Measures

Name	Time	Method
Optic nerve sheath diameter	After extubating the endotracheal tube (up to one hour)	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.

Secondary Outcome Measures

Name	Time	Method
Cerebral oxygenation	After extubating the endotracheal tube (up to one hour)	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.
Cognitive function	4 hours postoperatively	Cognitive function by standardized mini mental state examination (SMMSE) preoperative, and 4hours postoperatively.
Incidence of postoperative complications	24 hours postoperatively	Incidence of postoperative complications such as hypotension, bradycardia, postoperative nausea and vomiting (PONV), and headache will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt