Laparoscopic Hysterectomy, Lidocaine, Optic Nerve Sheath Diameter, Trendelenburg
Conditions
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.
Interventions
DRUGLidocaine
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
intravenous sodium chloride 0.9% solution volume matched bolus and infusion.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
Egypt
Outcome results
None listed