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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05690087
Other study ID # 36204/12/22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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