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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07062367
Enrollment
90
Registered
2025-07-14
Start date
2025-02-01
Completion date
2027-02-01
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

DRUGPropofol

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.

DRUGSevoflurane 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.

DRUGSevoflurane

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Optic nerve sheath diameterAfter 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

MeasureTime frameDescription
Cerebral oxygenationAfter 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 function4 hours postoperativelyCognitive function by standardized mini mental state examination (SMMSE) preoperative, and 4hours postoperatively.
Incidence of postoperative complications24 hours postoperativelyIncidence of postoperative complications such as hypotension, bradycardia, postoperative nausea and vomiting (PONV), and headache will be recorded.

Countries

Egypt

Contacts

Primary ContactEman A Elrefaey, Master
eman.elrefaey@med.tanta.edu.eg00201008031402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026