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

Tanta University

Status: Completed

Conditions: Optic Nerve Sheath Diameter; Trendelenburg; Laparoscopic Hysterectomy; Lidocaine

Treatments: Drug: Lidocaine; Drug: sodium chloride 0.9% solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05690087

36204/12/22

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

Lidocaine group

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: sodium chloride 0.9% solution