Dexmedetomidine Versus Lidocaine for Optic Nerve Sheath Diameter During Craniotomy Intubation

NCT07820540 — Phase 4, Not yet recruiting, 90 participants, Benha University

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

Registry	NCT07820540
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	90 (Estimated)
Sponsor	Benha University (Other)
Conditions	Endotracheal Intubation
Interventions	Dexmedetomidine, Lidocaine, Normal Saline (Drug)
Dates	start 2026-09-20 (estimated), primary completion 2027-06-15 (estimated), completion 2027-06-15 (estimated), first posted 2026-09-15, last updated 2026-09-15
Locations	1 site in Egypt

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Dexmedetomidine Group	Experimental	Drug: Dexmedetomidine	Participants will receive dexmedetomidine 1 microgram per kilogram intravenously, diluted in 100 milliliters of normal saline and administered over 10 minutes before induction of anesthesia.
Lidocaine Group	Active comparator	Drug: Lidocaine	Participants will receive lidocaine 1.5 milligrams per kilogram intravenously as a slow bolus 2-3 minutes before induction of anesthesia.
Control Group	Placebo comparator	Drug: Normal Saline	Participants will receive normal saline placebo intravenously before induction of anesthesia, administered in a manner intended to maintain study blinding.

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.

+Outcome measures

Primary outcomes

Optic Nerve Sheath Diameter [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

Heart Rate [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.
Mean Arterial Pressure [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.
Systolic Blood Pressure [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.
Diastolic Blood Pressure [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.
Incidence of Intraoperative Hemodynamic Adverse Events [Intraoperatively]: The number and percentage of participants experiencing any adverse event will be recorded.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Benha University Hospitals	Banhā, Qalyubia Governorate	Egypt