Hemodynamic Response to Laryngoscopy and Tracheal IntubationNCT07783256
Hemodynamic Responses to Laryngoscopy and Tracheal Intubation
A study testing ketodex and ketofol in people with Hemodynamic Response to Laryngoscopy and Tracheal Intubation, run by Assiut University.
Trial summary
Laryngoscopy and tracheal intubation lead to tachycardia and hypertension due to increase in the plasma catecholamines subsequent to sympathetic stimulation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemodynamic Response to Laryngoscopy and Tracheal Intubation
- What is being tested?
- ketodex and ketofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2026to 20 Dec 2028
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients scheduled for elective middle ear surgery under general anesthesia, ASA status I-II, aged from 18 to 60 years old of either sex.
Who cannot join
- Full stomach or emergency surgery
- Any known contraindications or allergy to ketamine, dexmedetomidine, or propofol
- Pregnancy or breastfeeding women
- Body mass index (BMI) > 35 Kg/m2
- History of hepatic, renal, or cardiac disease
- Patients in whom the duration of laryngoscopy will last more than 25 seconds
- Chronic opioid use, or history of neuropsychiatric disorders
- Patient refusal
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Intravenous Ketodex Versus Ketofol for Obtunding Hemodynamic Responses to Laryngoscopy and Tracheal Intubation in Adult Elective Middle Ear Surgery Patients: A Prospective Randomized Comparative Study
Laryngoscopy and tracheal intubation lead to tachycardia and hypertension due to increase in the plasma catecholamines subsequent to sympathetic stimulation.
Read the detailed description
Various prophylactic interventions have been tried to blunt the hemodynamic stress response to laryngoscopy and tracheal intubation. The ketamine-dexmedetomidine combination (ketodex) and ketamine-propofol combination (ketofol) may be of benefit in maintaining hemodynamic stability and reducing potential side effects of each drug.
- Being tested
- ketodex, ketofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketodexDrug
Patients will receive a single IV bolus dose of both ketamine and dexmedetomidine
ketofolDrug
Patients will receive a single IV bolus dose of both ketamine and propofol
| Study group | Role | What they receive |
|---|---|---|
| Ketodex | Active comparator | Patients will receive a single IV bolus dose of both ketamine and dexmedetomidine Receives: Drug: ketodex |
| Ketofol | Placebo comparator | Patients will receive a single IV bolus dose of both ketamine and propofol Receives: Drug: ketofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate accompanying laryngoscopy and tracheal intubation with cuff inflation
Assessed in beats per minute
Measured: The fifth minute after laryngoscopy and tracheal intubation with cuff inflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start20 Dec 2026 (estimated)
- Primary completion20 Dec 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic Response to Laryngoscopy and Tracheal IntubationStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
- Investigators
- Seham M Moeen, M.D., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783256
- Sponsor's protocol ID
- SM2082026
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intravenous Ketodex Versus Ketofol for Obtunding Hemodynamic Responses to Laryngoscopy and Tracheal Intubation in Adult Elective Middle Ear Surgery Patients: A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07783256
- Acronym / sponsor ID
- SM2082026
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2026 (estimated)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 24 Aug 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.
Laryngoscopy and tracheal intubation lead to tachycardia and hypertension due to increase in the plasma catecholamines subsequent to sympathetic stimulation.
Detailed description
Various prophylactic interventions have been tried to blunt the hemodynamic stress response to laryngoscopy and tracheal intubation. The ketamine-dexmedetomidine combination (ketodex) and ketamine-propofol combination (ketofol) may be of benefit in maintaining hemodynamic stability and reducing potential side effects of each drug.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketodex | Active comparator | Drug: ketodexPatients will receive a single IV bolus dose of both ketamine and dexmedetomidine |
| Ketofol | Placebo comparator | Drug: ketofolPatients will receive a single IV bolus dose of both ketamine and propofol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for elective middle ear surgery under general anesthesia, ASA status I-II, aged from 18 to 60 years old of either sex.
Key exclusion criteria (8 listed)
- Full stomach or emergency surgery
- Any known contraindications or allergy to ketamine, dexmedetomidine, or propofol
- Pregnancy or breastfeeding women
- Body mass index (BMI) > 35 Kg/m2
- History of hepatic, renal, or cardiac disease
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 |
|---|---|---|
| ketodexPatients will receive a single IV bolus dose of both ketamine and dexmedetomidine | Drug | Ketodex |
| ketofolPatients will receive a single IV bolus dose of both ketamine and propofol | Drug | Ketofol |
Primary outcome
Heart rate accompanying laryngoscopy and tracheal intubation with cuff inflation
Time frame: The fifth minute after laryngoscopy and tracheal intubation with cuff inflation
Assessed in beats per minute
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 24 Aug 2026.
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COMPARISON OF DEXMEDETOMIDINE AND NORMAL SALINE IN NEBULIZATION TO BLUNT HEMODYNAMIC RESPONSE
HEMODYNAMIC RESPONSETO LYRANGOSCOPY AND ENDOTRACHEAL INTUBATION
Recruiting
Comparative Efficacy of Intravenous Labetalol and Lignocaine in Mitigating Hemodynamic Responses to Laryngoscopy During Laparoscopic Cholecystectomy
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Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
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Gabapentin and Pressor Response to Intubation
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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.
Seham M Moeen, M.D. principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing ketodex and ketofol in people with Hemodynamic Response to Laryngoscopy and Tracheal Intubation, run by Assiut University.
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 1 inclusion and 8 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Seham M Moeen, M.D. (01006386324 ext. 02, seham.moeen@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate accompanying laryngoscopy and tracheal intubation with cuff inflation (time frame: The fifth minute after laryngoscopy and tracheal intubation with cuff inflation). 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 24 Aug 2026.