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NCT Number: NCT07062367

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

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).

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Key information

Conditions

Sevoflurane Cerebral Oxygenation Intracranial Pressure Laparoscopic Hysterectomy Lidocaine Propofol

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Ashraf E Elzeftawy, MD

SUB_INVESTIGATOR

Eman A Elrefaey, Master

CONTACT

[email protected]

00201008031402

Hesham M Marof, MD

SUB_INVESTIGATOR

Mohammed S Abdelghafar, MD

SUB_INVESTIGATOR

Osama M Rehab, MD

SUB_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Drug

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

Primary outcomes

  1. Optic nerve sheath diameter

    Time frame: 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 outcomes

  1. Cerebral oxygenation

    Time frame: 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.

  2. Cognitive function

    Time frame: 4 hours postoperatively

    Cognitive function by standardized mini mental state examination (SMMSE) preoperative, and 4hours postoperatively.

  3. Incidence of postoperative complications

    Time frame: 24 hours postoperatively

    Incidence of postoperative complications such as hypotension, bradycardia, postoperative nausea and vomiting (PONV), and headache will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Eman A Elrefaey, Master

CONTACT

[email protected]

00201008031402

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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