Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
36204/12/22
Description
We hypothesize that intravenous lidocaine infusion may have beneficial effect to patients undergoing laparoscopic surgeries in Trendelenburg position by preventing ICP elevation.
Trial arms
Trial start
2023-02-01
Estimated PCD
2024-01-01
Trial end
2024-01-01
Status
Completed
Treatment
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
Arms:
Lidocaine group
sodium chloride 0.9% solution
intravenous sodium chloride 0.9% solution volume matched bolus and infusion.
Arms:
Control group
Size
66
Primary endpoint
Optic Nerve Sheath Diameter (ONSD)
5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}
Updated at
2024-01-03

1 organization

2 products

4 indications

Organization
Tanta University
Product
Lidocaine
Indication
Lidocaine
Indication
optic nerve sheath diameter
Indication
Laparoscopic Hysterectomy
Indication
Trendelenburg
Product
Sodium Chloride