Lidocaine Infusion on Optic Nerve Sheath Diameter in Laparoscopic Hysterectomy in Trendelenburg Position

NCT ID: NCT05690087

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-01-01

Brief Summary

We hypothesize that intravenous lidocaine infusion may have beneficial effect to patients undergoing laparoscopic surgeries in Trendelenburg position by preventing ICP elevation.

Detailed Description

Lidocaine use, both intravenous (IV) and laryngotracheal (LT), has been reported to blunt the ICP elevations during intubation. Also, Lidocaine injected IV has been shown in models to induce cerebral vasoconstriction leading to a decrease in cerebral blood volume and thus ICP. Furthermore, IV lidocaine leads to sodium channel inhibition and thus a reduction in cerebral activity and metabolic demands, as well as excitotoxicity, leading to a potential ICP reduction effect.

Conditions

Lidocaine; Optic Nerve Sheath Diameter; Laparoscopic Hysterectomy; Trendelenburg

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine group

Intravenous lidocaine 2% bolus of 1.5 mg/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 1.5 mg/kg/h intraoperatively until desufflation.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

intravenous lidocaine 2% bolus of 1.5 mg/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 1.5 mg/kg/h intraoperatively until desufflation

Control group

Intravenous sodium chloride 0.9% solution volume matched in bolus and infusion.

Group Type: PLACEBO_COMPARATOR

sodium chloride 0.9% solution

Intervention Type: DRUG

intravenous sodium chloride 0.9% solution volume matched bolus and infusion.

Interventions

Lidocaine

intravenous lidocaine 2% bolus of 1.5 mg/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 1.5 mg/kg/h intraoperatively until desufflation

Intervention Type: DRUG

sodium chloride 0.9% solution

intravenous sodium chloride 0.9% solution volume matched bolus and infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged between 35 to 65 years
• American society of anesthesiology (ASA) physical status I - II
• Body mass index (BMI) between 18.5 to 28.0 kg/m2
• Scheduled for total laparoscopic hysterectomy taking approximately 2 h with a 30° Trendelenburg position for management of uterine fibroids or refractory dysfunctional uterine bleeding.

Exclusion Criteria

1. Patients with eye diseases, central nervous system diseases, cardiovascular diseases, cerebrovascular diseases or diabetes.

2. If these events occurred intraoperative:

• Ultrasound scans or measurements failed to clearly show the structure of Optic Nerve Sheath Diameter (ONSD).
• Surgical time less than 1 h.
• Interruption of carbon dioxide (CO2) pneumoperitoneum and Trendelenburg position.
• Peak airway pressure exceeding 35 cm H2O

3. Patients with a history of allergy to lidocaine.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Osama Rehab

Lecturer of Anesthesiology, Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospitals

Tanta, ElGharbiaa, Egypt

Countries

Egypt

Other Identifiers

36204/12/22

Identifier Type: -

Identifier Source: org_study_id