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

Not Applicable

Completed

• Conditions: Optic Nerve Sheath Diameter; Laparoscopic Hysterectomy; Lidocaine; Trendelenburg
• Interventions: Drug: sodium chloride 0.9% solution; Drug: Lidocaine

• Registration Number: NCT05690087
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-19
• Study Start: 2023-02-01
• Status Verified: 2023-03
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Last Update Submitted: 2024-01-01
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	sodium chloride 0.9% solution	Intravenous sodium chloride 0.9% solution volume matched in bolus and infusion.
Lidocaine group	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.

Primary Outcome Measures

Name	Time	Method
Optic Nerve Sheath Diameter (ONSD)	5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum	ONSD at 5 min before induction of anesthesia in supine position (T1), 5 min after CO2 pneumoperitoneum in Trendelenburg position (T2), 30 min after CO2 pneumoperitoneum in Trendelenburg position (T3), 60 min after CO2 pneumoperitoneum in Trendelenburg position (T4) and 5 min after the closure of pneumoperitoneum in supine position (T5).

Secondary Outcome Measures

Name	Time	Method
Heart rate	5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum	Heart rate at 5 min before induction of anesthesia in supine position (T1), 5 min after CO2 pneumoperitoneum in Trendelenburg position (T2), 30 min after CO2 pneumoperitoneum in Trendelenburg position (T3), 60 min after CO2 pneumoperitoneum in Trendelenburg position (T4) and 5 min after the closure of pneumoperitoneum in supine position (T5).
Mean arterial blood pressure	5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum	Mean arterial blood pressure at 5 min before induction of anesthesia in supine position (T1), 5 min after CO2 pneumoperitoneum in Trendelenburg position (T2), 30 min after CO2 pneumoperitoneum in Trendelenburg position (T3), 60 min after CO2 pneumoperitoneum in Trendelenburg position (T4) and 5 min after the closure of pneumoperitoneum in supine position (T5).
The incidence of postoperative adverse reactions	Within 3 hours after surgery	The incidence of adverse reactions, such as dizziness, postoperative nausea and vomiting (PONV) and postoperative headache (POHA) within 3 hours after surgery will be recorded in both groups.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, ElGharbiaa, Egypt