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

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05690087
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
5.9
Anticipated Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Systemic Lidocaine Infusion on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Hysterectomy in Trendelenburg Position
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lidocaine group

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
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
Placebo Comparator: Control group

Intravenous sodium chloride 0.9% solution volume matched in bolus and infusion.

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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).

  2. 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).

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts 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

  1. Patients with a history of allergy to lidocaine.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University Hospitals Tanta ElGharbiaa Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Osama Rehab, Lecturer of Anesthesiology, Intensive Care and Pain Medicine, Tanta University
ClinicalTrials.gov Identifier:
NCT05690087
Other Study ID Numbers:
  • 36204/12/22
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lidocaine

Study Results

No Results Posted as of Jan 25, 2023