Endotracheal IntubationPhase 4NCT07820540
Dexmedetomidine Versus Lidocaine for Optic Nerve Sheath Diameter During Craniotomy Intubation
A Phase 4 study testing Dexmedetomidine, Lidocaine and Normal Saline in people with Endotracheal Intubation, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Dexmedetomidine, Lidocaine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2026to 15 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Raised intraocular pressure
- Pre-existing eye disease or ocular injury
- Severe cardiac or pulmonary disease
- Hepatic or renal impairment
- Coagulopathy
- Pregnancy
Show all 9Show fewer
- Known allergy to any of the study drugs
- Difficult airway
- Emergency craniotomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Benha University Hospitals
Banhā, Qalyubia Governorate, 13511
Ahmed S Thabet, MSc, +965 553 09982, Drsalem2019@yahoo.com
About this study
Official title: Effects of Intravenous Dexmedetomidine Versus Lidocaine on Optic Nerve Sheath Diameter During Endotracheal Intubation in Patients Undergoing Craniotomy: A Randomized Controlled 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.
- Conditions
- Endotracheal Intubation
- Being tested
- Dexmedetomidine, Lidocaine, Normal Saline
- Keywords
- Optic nerve sheath diameter, Intracranial pressure, Endotracheal intubation, Craniotomy, Dexmedetomidine, Lidocaine, Hemodynamic response, Neuroanesthesia, Ultrasonography, Supratentorial craniotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine will be administered intravenously at a dose of 1 microgram per kilogram over 10 minutes before induction of general anesthesia.
LidocaineDrug
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 SalineDrug
Normal saline will be administered intravenously as placebo before induction of general anesthesia in a manner intended to maintain study blinding.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | 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. Receives: Drug: Dexmedetomidine |
| Lidocaine Group | Active comparator | Participants will receive lidocaine 1.5 milligrams per kilogram intravenously as a slow bolus 2-3 minutes before induction of anesthesia. Receives: Drug: Lidocaine |
| Control Group | Placebo comparator | Participants will receive normal saline placebo intravenously before induction of anesthesia, administered in a manner intended to maintain study blinding. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative: baseline before induction; immediately after induction before laryngoscopy; immediately after intubation; 5 and 10 minutes after intubation.
Secondary outcomes (5)
Heart Rate
Heart rate will be recorded to assess the hemodynamic response to induction of anesthesia and endotracheal intubation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salem Thabet, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820540
- Sponsor's protocol ID
- MD.3.6.2026
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Dexmedetomidine Versus Lidocaine on Optic Nerve Sheath Diameter During Endotracheal Intubation in Patients Undergoing Craniotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07820540
- Acronym / sponsor ID
- MD.3.6.2026
- Conditions
- Endotracheal Intubation
- Keywords
- Optic nerve sheath diameter, Intracranial pressure, Endotracheal intubation, Craniotomy, Dexmedetomidine, Lidocaine, Hemodynamic response, Neuroanesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: DexmedetomidineParticipants 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: LidocaineParticipants 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 SalineParticipants will receive normal saline placebo intravenously before induction of anesthesia, administered in a manner intended to maintain study blinding. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Raised intraocular pressure
- Pre-existing eye disease or ocular injury
- Severe cardiac or pulmonary disease
- Hepatic or renal impairment
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDexmedetomidine will be administered intravenously at a dose of 1 microgram per kilogram over 10 minutes before induction of general anesthesia. | Drug | Dexmedetomidine Group |
| LidocaineLidocaine 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. | Drug | Lidocaine Group |
| Normal SalineNormal saline will be administered intravenously as placebo before induction of general anesthesia in a manner intended to maintain study blinding. | Drug | Control Group |
Primary outcome
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.
5 secondary outcomes
Heart Rate
Time frame: Perioperative: baseline before induction; immediately after induction before laryngoscopy; and 1, 5, and 10 minutes after intubation.
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.
Systolic Blood Pressure
Time frame: Perioperative: baseline before induction; immediately after induction before laryngoscopy; and 1, 5, and 10 minutes after intubation.
Diastolic Blood Pressure
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
Time frame: Intraoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Lidocaine and Normal Saline in people with Endotracheal Intubation, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed S Thabet, MSc (+965 553 09982, Drsalem2019@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic Nerve Sheath Diameter (time frame: Perioperative: baseline before induction; immediately after induction before laryngoscopy; immediately after intubation; 5 and 10 minutes after intubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.