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

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

Detailed Description
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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.

Official Title
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Effect of Systemic Lidocaine Infusion on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Hysterectomy in Trendelenburg Position

Conditions
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Lidocaine, Optic Nerve Sheath Diameter, Laparoscopic Hysterectomy, Trendelenburg

Intervention / Treatment
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* Drug: Lidocaine
* Drug: sodium chloride 0.9% solution


Participation Criteria
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Eligibility Criteria
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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: Patients with eye diseases, central nervous system diseases, cardiovascular diseases, cerebrovascular diseases or diabetes. 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 Patients with a history of allergy to lidocaine.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine group<br>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. | Drug: Lidocaine<br>* 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<br>|
| Placebo Comparator: Control group<br>Intravenous sodium chloride 0.9% solution volume matched in bolus and infusion. | Drug: sodium chloride 0.9% solution<br>* intravenous sodium chloride 0.9% solution volume matched bolus and infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic Nerve Sheath Diameter (ONSD) | 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). | 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | 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). | 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum | 
| Mean arterial blood pressure | 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). | 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum | 
| The incidence of postoperative adverse reactions | 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. | Within 3 hours after surgery |