Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07820540

Dexmedetomidine Versus Lidocaine for Optic Nerve Sheath Diameter During Craniotomy Intubation

Endotracheal intubation during general anesthesia can cause temporary increases in heart rate, blood pressure, and intracranial pressure. These changes may be particularly important in patients undergoing craniotomy. Optic nerve sheath diameter, measured noninvasively using ultrasound, can be used as an indirect marker of changes in intracranial pressure.

This randomized controlled trial will compare intravenous dexmedetomidine, intravenous lidocaine, and normal saline in patients undergoing elective supratentorial craniotomy under general anesthesia. The study will evaluate whether dexmedetomidine or lidocaine can reduce changes in optic nerve sheath diameter associated with endotracheal intubation and improve hemodynamic stability compared with placebo.

The investigators hypothesize that dexmedetomidine and lidocaine will attenuate the increase in optic nerve sheath diameter and the hemodynamic response associated with endotracheal intubation.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Endotracheal Intubation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Benha University Hospitals

Banhā, Qalyubia Governorate, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 to 65 years
  • Male or female participants
  • American Society of Anesthesiologists physical status I to III
  • Scheduled for elective supratentorial craniotomy under general anesthesia

Exclusion criteria

  • Raised intraocular pressure
  • Pre-existing eye disease or ocular injury
  • Severe cardiac or pulmonary disease
  • Hepatic or renal impairment
  • Coagulopathy
  • Pregnancy
  • Known allergy to any of the study drugs
  • Difficult airway
  • Emergency craniotomy

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine will be administered intravenously at a dose of 1 microgram per kilogram over 10 minutes before induction of general anesthesia.

Lidocaine

Drug

Lidocaine will be administered intravenously at a dose of 1.5 milligrams per kilogram as a slow bolus 2-3 minutes before induction of general anesthesia.

normal saline

Drug

Normal saline will be administered intravenously as placebo before induction of general anesthesia in a manner intended to maintain study blinding.

Primary outcomes

  1. Optic Nerve Sheath Diameter

    Time frame: Perioperative: baseline before induction; immediately after induction before laryngoscopy; immediately after intubation; 5 and 10 minutes after intubation.

    Optic nerve sheath diameter will be measured in millimeters using ultrasonography with a high-frequency linear probe placed gently over the closed upper eyelid. The measurement will be obtained 3 millimeters posterior to the globe.

Secondary outcomes

  1. Heart Rate

    Time frame: Perioperative: baseline before induction; immediately after induction before laryngoscopy; and 1, 5, and 10 minutes after intubation.

    Heart rate will be recorded to assess the hemodynamic response to induction of anesthesia and endotracheal intubation.

  2. Mean Arterial Pressure

    Time frame: Perioperative: baseline before induction of general anesthesia; immediately after completion of induction and before laryngoscopy; and 1, 5, and 10 minutes after endotracheal intubation.

    Mean arterial pressure will be recorded to assess changes in hemodynamic response associated with induction of anesthesia and endotracheal intubation.

  3. Systolic Blood Pressure

    Time frame: Perioperative: baseline before induction; immediately after induction before laryngoscopy; and 1, 5, and 10 minutes after intubation.

    Systolic blood pressure will be recorded to assess changes associated with induction of anesthesia and endotracheal intubation.

  4. Diastolic Blood Pressure

    Time frame: Perioperative: baseline before induction; immediately after induction before laryngoscopy; and 1, 5, and 10 minutes after intubation.

    Diastolic blood pressure will be recorded to assess changes associated with induction of anesthesia and endotracheal intubation.

  5. Incidence of Intraoperative Hemodynamic Adverse Events

    Time frame: Intraoperatively

    The number and percentage of participants experiencing any adverse event will be recorded.

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Effects of Intravenous Dexmedetomidine Versus Lidocaine on Optic Nerve Sheath Diameter During Endotracheal Intubation in Patients Undergoing Craniotomy: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.