Endotracheal Intubation
Conditions
Keywords
Optic nerve sheath diameter, Intracranial pressure, Endotracheal intubation, Craniotomy, Dexmedetomidine, Lidocaine, Hemodynamic response, Neuroanesthesia, Ultrasonography, Supratentorial craniotomy
Brief 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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine will be administered intravenously at a dose of 1 microgram per kilogram over 10 minutes before induction of general anesthesia.
DRUGLidocaine
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.
DRUGNormal Saline
Normal saline will be administered intravenously as placebo before induction of general anesthesia in a manner intended to maintain study blinding.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and the investigator responsible for data collection and outcome assessment will be blinded to group allocation. Study medications will be prepared by an independent anesthesiologist who will not participate in patient management, data collection, or outcome assessment.
Intervention model description
Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups receiving intravenous dexmedetomidine, intravenous lidocaine, or normal saline before induction of general anesthesia.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Contacts
CONTACTAhmed S Thabet, MSc
Outcome results
None listed