NCT05690087

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 3, 2024

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

January 10, 2023

Last Update Submit

January 1, 2024

Conditions

LidocaineOptic Nerve Sheath DiameterLaparoscopic HysterectomyTrendelenburg

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Heart rate

    5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum

  • Mean arterial blood pressure

    5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum

  • The incidence of postoperative adverse reactions

    Within 3 hours after surgery

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Drug: sodium chloride 0.9% solution

Interventions

LidocaineDRUG

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

Lidocaine group
sodium chloride 0.9% solutionDRUG

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

Control group

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients scheduled for laparoscopic hysterectomy surgery.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with eye diseases, central nervous system diseases, cardiovascular diseases, cerebrovascular diseases or diabetes.
  • 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
  • Patients with a history of allergy to lidocaine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

Location

MeSH Terms

Interventions

LidocaineSodium ChlorideSolutions

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Intensive Care and Pain Medicine

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 19, 2023

Study Start

February 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

January 3, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

The data will be available upon reasonable request from the corresponding author

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After completion of the study
Access Criteria
The data will be available upon reasonable request from the corresponding author

Locations

EG(1)