Tracheal Intubation MorbidityPhase 2/3NCT06935292
Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
A Phase 2/3 study testing Dexmedetomidine and Melatonin in people with Tracheal Intubation Morbidity and Laryngoscopy, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the efficacy of oral melatonin versus nebulized dexmedetomidine in attenuating the hemodynamic response to direct laryngoscopy and endotracheal intubation in controlled hypertensive patients prepared for general anesthesia Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Tracheal Intubation Morbidity, Laryngoscopy, Hemodynamic Response
- What is being tested?
- Dexmedetomidine and Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2025to Apr 2026
- Phase
- Phase 2/3
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age (40-60) years of both genders.
- Controlled hypertensive patients.
- Categorized as ASA physical status II.
- Planning to do an elective surgery under General Anesthesia.
Who cannot join
- Patient refusal to participate in the study.
- Patient with expected difficult intubation.
- Body Mass Index (BMI) > 30 kg/m2.
- History of allergy to the drugs of the study.
- Patients with Heart rate<50 or Heart block.
- End stage renal and hepatic disease.
- Patients on beta blocker, oral hypoglycemics, anti-depressants, anti-convulsants, anti- psychotics and thyroid medications.
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study Between Oral Melatonin and Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients: A Prospective Randomized Trial
The aim of this study is to compare the efficacy of oral melatonin versus nebulized dexmedetomidine in attenuating the hemodynamic response to direct laryngoscopy and endotracheal intubation in controlled hypertensive patients prepared for general anesthesia
Read the detailed description
Laryngoscopy and endotracheal intubation are associated with sympathetic stimulation and induce hemodynamic changes with consequent increase in heart rate (HR) and blood pressure (BP) which may lead to myocardial infarction, cardiac arrhythmias, cardiac failure and cerebrovascular accidents in patients with underlying cardiovascular or cerebrovascular diseases.
Dexmedetomidine is a centrally acting α-2 adrenergic agonist with sedative, hypnotic, analgesic, anxiolytic, anti-sialagogue, antinociceptive and sympatholytic action. Premedication with dexmedetomidine through intravenous, intramuscular and intranasal route has been shown to effectively attenuate hemodynamic response to laryngoscopy and endotracheal intubation. Nebulization provides an alternative route of dexmedetomidine premedication with high bioavailability through both nasal (65%) and oral mucosa (82%) and avoids a venipuncture as a prerequisite. Recent studies have shown nebulization as a novel route of dexmedetomidine administration for attenuation of hemodynamic response to endotracheal intubation.
Melatonin is a natural substance produced mainly in the pineal gland of all mammals and vertebrates. It is rapidly distributed and eliminated after intravenous administration. After oral administration, plasma concentration peaks after 60 min and is then eliminated. It exerts its hypnotic effects through the activation of the Melatonin receptors type I and II (MT1, MT2). It has shown potent analgesic effects in a dose dependent manner in experimental studies. It may induce relaxation of the arterial wall smooth muscle by increasing nitric oxide levels. Therefore, premedication with sublingual/oral Melatonin is associated with pre-operative anxiolysis and sedation without impairment of orientation, psychomotor skills, or impact on quality of recovery, moreover, it attenuates the hemodynamic stress response to laryngoscopy and tracheal intubation.
- Being tested
- Dexmedetomidine, Melatonin
- Keywords
- Direct laryngoscope, Dexmedetomidine, Melatonin, Tracheal Intubation, Hypertension, Hemodynamic response
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Nebulized Dexmedetomidine (1μg/kg)
MelatoninDrug
Also called Circadin
Oral Melatonin tablet (5mg)
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Participants in this group will receive nebulized dexmedetomidine (1μg/kg) one hour before induction of anesthesia Receives: Drug: Dexmedetomidine |
| Melatonin group | Experimental | Participants in this group will receive melatonin oral tablet (5mg) one hour before induction of anesthesia Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate (HR)
Heart Rate will be assessed using pulse oximeter in pre-operative room (baseline), before the induction of anesthesia, immediately before laryngescopy or intubation, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, every 30 minutes till the end of operation.
Measured: Till the end of surgery (up to 2 hours)
Secondary outcomes (3)
Change in Systolic and Diastolic blood pressure
Systolic and diastolic blood pressure will be recorded in pre-operative room (baseline), before the induction of anesthesia, immediately before laryngescopy or intubation, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, every 30 minutes till the end of operation.
Measured: Till the end of surgery (up to 2 hours)
Sedation levels using Ramsay Sedation Scale
Sedation levels will be assessed using Ramsay Sedation Scale (1, Anxious and agitated, restless, or both; 2, Cooperative, oriented, and calm; 3 Responsive to commands only; 4 Exhibiting brisk response to light glabellar tap or loud auditory stimulus; 5, Exhibiting a sluggish response to light glabellar tap or loud auditory stimulus; 6, Unresponsive) before administration of the study drugs, before induction of anesthesia (60 minutes after drug taken), every 30 minutes post operative till 2 hours after surgery.
Measured: Till 2 hours after the surgery
Intraoperative requirement of fentanyl
Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal Intubation MorbidityStudies of the same condition, open and under way.
- More trials run by Tanta 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dexmedetomidine will be given in the form of nebulized dexmedetomidine (1μg/kg) one hour before induction of anesthesia. Melatonin will be given as melatonin oral tablet (5mg) one hour before induction of anesthesia.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Abo Elfotoh Ismaeil, Tanta University
- Investigators
- Aya GAE Ismaeil, MBBCH, Principal investigator, Faculty of Medicine, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935292
- Sponsor's protocol ID
- 36264MS867/3/25
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Oral Melatonin and Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06935292
- Acronym / sponsor ID
- 36264MS867/3/25
- Keywords
- Direct laryngoscope, Dexmedetomidine, Melatonin, Tracheal Intubation, Hypertension, Hemodynamic response
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 20 Apr 2025 (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.
The aim of this study is to compare the efficacy of oral melatonin versus nebulized dexmedetomidine in attenuating the hemodynamic response to direct laryngoscopy and endotracheal intubation in controlled hypertensive patients prepared for general anesthesia
Detailed description
Laryngoscopy and endotracheal intubation are associated with sympathetic stimulation and induce hemodynamic changes with consequent increase in heart rate (HR) and blood pressure (BP) which may lead to myocardial infarction, cardiac arrhythmias, cardiac failure and cerebrovascular accidents in patients with underlying cardiovascular or cerebrovascular diseases.
Dexmedetomidine is a centrally acting α-2 adrenergic agonist with sedative, hypnotic, analgesic, anxiolytic, anti-sialagogue, antinociceptive and sympatholytic action. Premedication with dexmedetomidine through intravenous, intramuscular and intranasal route has been shown to effectively attenuate hemodynamic response to laryngoscopy and endotracheal intubation. Nebulization provides an alternative route of dexmedetomidine premedication with high bioavailability through both nasal (65%) and oral mucosa (82%) and avoids a venipuncture as a prerequisite. Recent studies have shown nebulization as a novel route of dexmedetomidine administration for attenuation of hemodynamic response to endotracheal intubation.
Melatonin is a natural substance produced mainly in the pineal gland of all mammals and vertebrates. It is rapidly distributed and eliminated after intravenous administration. After oral administration, plasma concentration peaks after 60 min and is then eliminated. It exerts its hypnotic effects through the activation of the Melatonin receptors type I and II (MT1, MT2). It has shown potent analgesic effects in a dose dependent manner in experimental studies. It may induce relaxation of the arterial wall smooth muscle by increasing nitric oxide levels. Therefore, premedication with sublingual/oral Melatonin is associated with pre-operative anxiolysis and sedation without impairment of orientation, psychomotor skills, or impact on quality of recovery, moreover, it attenuates the hemodynamic stress response to laryngoscopy and tracheal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dexmedetomidine will be given in the form of nebulized dexmedetomidine (1μg/kg) one hour before induction of anesthesia. Melatonin will be given as melatonin oral tablet (5mg) one hour before induction of anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineParticipants in this group will receive nebulized dexmedetomidine (1μg/kg) one hour before induction of anesthesia |
| Melatonin group | Experimental | Drug: MelatoninParticipants in this group will receive melatonin oral tablet (5mg) one hour before induction of anesthesia |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age (40-60) years of both genders.
- Controlled hypertensive patients.
- Categorized as ASA physical status II.
- Planning to do an elective surgery under General Anesthesia.
Key exclusion criteria (8 listed)
- Patient refusal to participate in the study.
- Patient with expected difficult intubation.
- Body Mass Index (BMI) > 30 kg/m2.
- History of allergy to the drugs of the study.
- Patients with Heart rate<50 or Heart block.
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexNebulized Dexmedetomidine (1μg/kg) | Drug | Dexmedetomidine group |
| MelatoninAlso: CircadinOral Melatonin tablet (5mg) | Drug | Melatonin group |
Primary outcome
Change in Heart Rate (HR)
Time frame: Till the end of surgery (up to 2 hours)
Heart Rate will be assessed using pulse oximeter in pre-operative room (baseline), before the induction of anesthesia, immediately before laryngescopy or intubation, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, every 30 minutes till the end of operation.
3 secondary outcomes
Change in Systolic and Diastolic blood pressure
Time frame: Till the end of surgery (up to 2 hours)
Sedation levels using Ramsay Sedation Scale
Time frame: Till 2 hours after the surgery
Intraoperative requirement of fentanyl
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 20 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Tracheal Intubation Morbidity
Recruiting
Optimisation Strategy for Emergency Tracheal Intubation
Emergencies, Out-of-hospital Setting
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.
Aya GAE Ismaeil, MBBCH principal investigator
Faculty of Medicine, Tanta University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine and Melatonin in people with Tracheal Intubation Morbidity and Laryngoscopy, run by Tanta 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 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 20 Apr 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Aya GAE Ismaeil, MBBCH (+201159716507, ayagamal9009@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate (HR) (time frame: Till the end of surgery (up to 2 hours)). 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 20 Apr 2025.