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

ConditionsSevofluraneLidocainePropofolIntracranial PressureCerebral OxygenationLaparoscopic Hysterectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorTanta University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Propofol groupActive comparator 1 intervention
Group B: Sevoflurane plus lidocaine infusion groupExperimental treatment 1 intervention
Group C: Sevoflurane groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
After extubating the endotracheal tube (up to one hour)

Secondary outcomes

1

Cerebral oxygenation

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.

Time frame
After extubating the endotracheal tube (up to one hour)
2

Cognitive function

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

Time frame
4 hours postoperatively
3

Incidence of postoperative complications

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

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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