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

NCT07062367 | Recruiting

• 1 other identifier: 36265MD329/12/24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Sevoflurane; Lidocaine; Propofol; Intracranial Pressure; Cerebral Oxygenation; Laparoscopic Hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  After extubating the endotracheal tube (up to one hour)

Secondary Outcomes (3)

• Cerebral oxygenation

  After extubating the endotracheal tube (up to one hour)

• Cognitive function

  4 hours postoperatively

• Incidence of postoperative complications

  24 hours postoperatively

Study Arms (3)

Propofol group

ACTIVE COMPARATOR

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 plus lidocaine infusion group

EXPERIMENTAL

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

Sevoflurane group

EXPERIMENTAL

Patients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60.

Drug: Sevoflurane

Interventions

Propofol DRUG

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.

Propofol group

Sevoflurane plus lidocaine infusion DRUG

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 plus lidocaine infusion group

Sevoflurane DRUG

Patients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60.

Sevoflurane group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Females scheduled for laparoscopic hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Central Study Contacts

Eman A Elrefaey, Master

CONTACT

00201008031402; eman.elrefaey@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)