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

NCT ID: NCT07062367

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-02-01

Brief Summary

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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

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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).

Conditions

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Sevoflurane Lidocaine Propofol Intracranial Pressure Cerebral Oxygenation Laparoscopic Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propofol group

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.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type 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 group

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.

Group Type EXPERIMENTAL

Sevoflurane plus lidocaine infusion

Intervention Type 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 group

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

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Sevoflurane

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Eman Ali Abd-Elsamea Elrefaey

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eman A Elrefaey, Master

Role: CONTACT

00201008031402

Facility Contacts

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Eman A Elrefaey, Master

Role: primary

00201008031402

Other Identifiers

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36265MD329/12/24

Identifier Type: -

Identifier Source: org_study_id

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