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

Lidocaine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690087
• Other study ID #: 36204/12/22
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Hysterectomy
• Lidocaine
• Optic Nerve Sheath Diameter

Intervention

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

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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