A Phase 4 interventional study of Dexmedetomidine and Lidocaine in Endotracheal Intubation, sponsored by Benha University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Benha University · Phase 4, Interventional, and Prevention
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.
Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dexmedetomidine
Participants will receive lidocaine 1.5 milligrams per kilogram intravenously as a slow bolus 2-3 minutes before induction of anesthesia.
Drug: Lidocaine
Participants will receive normal saline placebo intravenously before induction of anesthesia, administered in a manner intended to maintain study blinding.
Drug: Normal Saline
Dexmedetomidine will be administered intravenously at a dose of 1 microgram per kilogram over 10 minutes before induction of general anesthesia.
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 will be administered intravenously as placebo before induction of general anesthesia in a manner intended to maintain study blinding.
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.
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.
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.
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.
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.
Incidence of Intraoperative Hemodynamic Adverse Events
The number and percentage of participants experiencing any adverse event will be recorded.
Time frame: Intraoperatively
Start is estimated for Sep 2026; primary completion for Jun 2027, 8 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine