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Dexmedetomidine Versus Lidocaine for Optic Nerve Sheath Diameter During Craniotomy Intubation

ConditionEndotracheal Intubation
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBenha University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Raised intraocular pressure

Pre-existing eye disease or ocular injury

Severe cardiac or pulmonary disease

Hepatic or renal impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Dexmedetomidine GroupExperimental treatment 1 intervention
Group B: Lidocaine GroupActive comparator 1 intervention
Group C: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Optic Nerve Sheath Diameter

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.

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

Secondary outcomes

1

Heart Rate

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

Time frame
Perioperative: baseline before induction; immediately after induction before laryngoscopy; and 1, 5, and 10 minutes after intubation.
2

Mean Arterial Pressure

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

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.
3

Systolic Blood Pressure

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

Time frame
Perioperative: baseline before induction; immediately after induction before laryngoscopy; and 1, 5, and 10 minutes after intubation.
4

Diastolic Blood Pressure

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: