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Recruiting NCT07062367

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

No phase Interventional Sevoflurane Lidocaine Propofol Intracranial Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Propofol, Sevoflurane plus lidocaine infusion, Sevoflurane.
Who it may be relevant to
Registry conditions: Sevoflurane, Lidocaine, Propofol, Intracranial Pressure. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Optic nerve sheath diameter [Time frame: After extubating the endotracheal tube (up to one hour)]
Secondary outcome measures (3)
  • Cerebral oxygenation [Time frame: After extubating the endotracheal tube (up to one hour)]
  • Cognitive function [Time frame: 4 hours postoperatively]
  • Incidence of postoperative complications [Time frame: 24 hours postoperatively]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta University — Tanta

Identifiers

NCT: NCT07062367 · 36265MD329/12/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗