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NCT Number: NCT05690087

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

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

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Key information

Conditions

Lidocaine Laparoscopic Hysterectomy Optic Nerve Sheath Diameter Trendelenburg

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Lidocaine

Drug

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

Drug

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

Primary outcomes

  1. Optic Nerve Sheath Diameter (ONSD)

    Time frame: 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 outcomes

  1. Heart rate

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2023
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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