Stress Response of Endotracheal Intubation and Surgical Field Clarity in FESSNCT07568873
Melatonin vs Metoprolol or Dexmedetomidine to Improve Surgical Field in FESS
A study testing Melatonin, Metoprolol (MET) and Dexmedetomidine in people with Stress Response of Endotracheal Intubation and Surgical Field Clarity in FESS, run by Zagazig University at 1 site in Egypt.
Trial summary
This randomized controlled study at Zagazig University Hospitals will include 112 patients undergoing elective functional endoscopic sinus surgery, allocated into four groups (Melatonin, Metoprolol, Dexmedetomidine, Control). Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Stress Response of Endotracheal Intubation and Surgical Field Clarity in FESS
- What is being tested?
- Melatonin, Metoprolol (MET) and Dexmedetomidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient acceptance.
- Age: 21-60 years old.
- Body mass index (BMI): 18-30 kg/m2. 8
- Sex: both sexes (male and female).
- Physical status: American Society of Anesthesiologists (ASA) physical status I and II.
- Type of operation: elective functioning endoscopic sinus surgery.
- Duration of surgery: average 2 hours.
Who cannot join
- Hypertension and those on beta blockers and calcium channel blockers.
- Diabetes mellitus and bronchial asthma.
- Cardiac arrhythmias, atrio-ventricular conduction block, pulse less than 60 beats/min systolic blood pressure less than 100 mm hg.
- Patients with anticipated difficult intubation (Mallampati score III and IV).
- Psychiatric illness, intake of antipsychotics, sedatives, anxiolytics and antiepileptic drug.
- The pregnant and lactating females.
- Allergy to one of the used drugs.
- Patient with coagulation disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Zagazig Univeristy
Zagazig, Sharqia Province, 44519
About this study
Official title: Oral Melatonin Versus Intravenous Metoprolol or Dexmedetomidine for Attenuation of Stress Response to Endotracheal Intubation and Optimizing Surgical Field in Functional Endoscopic Sinus Surgery
This randomized controlled study at Zagazig University Hospitals will include 112 patients undergoing elective functional endoscopic sinus surgery, allocated into four groups (Melatonin, Metoprolol, Dexmedetomidine, Control). Preoperatively, patients will provide consent, undergo history, clinical and airway assessment, baseline vitals, laboratory tests, and serum cortisol and glucose measurement. Intraoperatively, standard monitoring will be applied, and study drugs administered according to group. Anesthesia will be induced with propofol, fentanyl, and atracurium, and maintained with isoflurane and controlled ventilation. Hemodynamics will be continuously monitored, and surgical field graded using ACS score, with interventions for hypotension, bradycardia, or tachycardia as needed. Postoperatively, emergence agitation, hemodynamics, and drug-related side effects will be recorded, and surgeon satisfaction assessed with a 5-point Likert scale.
- Being tested
- Melatonin, Metoprolol (MET), Dexmedetomidine, Placebo capsules (vitamin d)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called group ML
wo melatonin capsules (3 mg each) 60 minutes before surgery, intravenous normal saline in a 10 ml 11 syringe 5 minutes before induction and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction
Metoprolol (MET)Drug
4 mg of intravenous metoprolol diluted to a volume of 10 ml normal saline 5 minutes before induction, and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a
DexmedetomidineDrug
intravenous normal saline in a 10 ml syringe 5 minutes before induction and 1 microgram/Kg of dexmedetomidine diluted to a volume of 50 ml normal saline in a 50 ml syringe over 10 minutes before induction.
Placebo capsules (vitamin d)Drug
Also called Placebo comparator (Control group)
two placebo capsules (vitamin D) 60 minutes before surgery, intravenous normal saline in a 10 ml syringe 5 minutes before induction and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | receive two placebo capsules (vitamin D) 60 minutes before surgery, intravenous normal saline in a 10 ml syringe 5 minutes before induction and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction. Receives: Drug: Placebo capsules (vitamin d) |
| group ML | Other | will receive two melatonin capsules (3 mg each) 60 minutes before surgery, intravenous normal saline in a 10 ml 11 syringe 5 minutes before induction and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction. Receives: Drug: Melatonin |
| group MP | Other | will receive two placebo capsules (vitamin D) 60 minutes before surgery, 4 mg of intravenous metoprolol diluted to a volume of 10 ml normal saline 5 minutes before induction, and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction. Receives: Drug: Metoprolol (MET) |
| dexmedetomidine group | Other | will receive two placebo capsules (vitamin D) 60 minutes before surgery, intravenous normal saline in a 10 ml syringe 5 minutes before induction and 1 microgram/Kg of dexmedetomidine diluted to a volume of 50 ml normal saline in a 50 ml syringe over 10 minutes before induction. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in the mean arterial pressure measured in mmHg.
surgical field clarity depends on hemodynamic changes as it becomes more clear when heart rate and mean arterial pressure become lower within the safe range
Measured: 2 hours
Assessment of heart rate measured in beats/minute
Assessment of heart rate measured in beats/minute to assess surgical field by ACS score in FES
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start25 Jan 2024
- Primary completion1 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Response of Endotracheal Intubation and Surgical Field Clarity in FESSStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568873
- Sponsor's protocol ID
- Zagazig-IRB-------------------
- Status last verified
- Jan 2024
- First submitted
- 30 Mar 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Melatonin Versus Intravenous Metoprolol or Dexmedetomidine for Attenuation of Stress Response to Endotracheal Intubation and Optimizing Surgical Field in Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT07568873
- Acronym / sponsor ID
- Zagazig-IRB-------------------
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 6 May 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.
This randomized controlled study at Zagazig University Hospitals will include 112 patients undergoing elective functional endoscopic sinus surgery, allocated into four groups (Melatonin, Metoprolol, Dexmedetomidine, Control). Preoperatively, patients will provide consent, undergo history, clinical and airway assessment, baseline vitals, laboratory tests, and serum cortisol and glucose measurement. Intraoperatively, standard monitoring will be applied, and study drugs administered according to group. Anesthesia will be induced with propofol, fentanyl, and atracurium, and maintained with isoflurane and controlled ventilation. Hemodynamics will be continuously monitored, and surgical field graded using ACS score, with interventions for hypotension, bradycardia, or tachycardia as needed. Postoperatively, emergence agitation, hemodynamics, and drug-related side effects will be recorded, and surgeon satisfaction assessed with a 5-point Likert scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Placebo capsules (vitamin d)receive two placebo capsules (vitamin D) 60 minutes before surgery, intravenous normal saline in a 10 ml syringe 5 minutes before induction and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction. |
| group ML | Other | Drug: Melatoninwill receive two melatonin capsules (3 mg each) 60 minutes before surgery, intravenous normal saline in a 10 ml 11 syringe 5 minutes before induction and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction. |
| group MP | Other | Drug: Metoprolol (MET)will receive two placebo capsules (vitamin D) 60 minutes before surgery, 4 mg of intravenous metoprolol diluted to a volume of 10 ml normal saline 5 minutes before induction, and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction. |
| dexmedetomidine group | Other | Drug: Dexmedetomidinewill receive two placebo capsules (vitamin D) 60 minutes before surgery, intravenous normal saline in a 10 ml syringe 5 minutes before induction and 1 microgram/Kg of dexmedetomidine diluted to a volume of 50 ml normal saline in a 50 ml syringe over 10 minutes before induction. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient acceptance.
- Age: 21-60 years old.
- Body mass index (BMI): 18-30 kg/m2. 8
- Sex: both sexes (male and female).
- Physical status: American Society of Anesthesiologists (ASA) physical status I and II.
Key exclusion criteria (8 listed)
- Hypertension and those on beta blockers and calcium channel blockers.
- Diabetes mellitus and bronchial asthma.
- Cardiac arrhythmias, atrio-ventricular conduction block, pulse less than 60 beats/min systolic blood pressure less than 100 mm hg.
- Patients with anticipated difficult intubation (Mallampati score III and IV).
- Psychiatric illness, intake of antipsychotics, sedatives, anxiolytics and antiepileptic drug.
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 |
|---|---|---|
| MelatoninAlso: group MLwo melatonin capsules (3 mg each) 60 minutes before surgery, intravenous normal saline in a 10 ml 11 syringe 5 minutes before induction and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction | Drug | group ML |
| Metoprolol (MET)4 mg of intravenous metoprolol diluted to a volume of 10 ml normal saline 5 minutes before induction, and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a | Drug | group MP |
| Dexmedetomidineintravenous normal saline in a 10 ml syringe 5 minutes before induction and 1 microgram/Kg of dexmedetomidine diluted to a volume of 50 ml normal saline in a 50 ml syringe over 10 minutes before induction. | Drug | dexmedetomidine group |
| Placebo capsules (vitamin d)Also: Placebo comparator (Control group)two placebo capsules (vitamin D) 60 minutes before surgery, intravenous normal saline in a 10 ml syringe 5 minutes before induction and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction. | Drug | Control group |
Primary outcome
Assessment of change in the mean arterial pressure measured in mmHg.
Time frame: 2 hours
surgical field clarity depends on hemodynamic changes as it becomes more clear when heart rate and mean arterial pressure become lower within the safe range
Assessment of heart rate measured in beats/minute
Time frame: 2 hours
Assessment of heart rate measured in beats/minute to assess surgical field by ACS score in FES
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin, Metoprolol (MET) and Dexmedetomidine in people with Stress Response of Endotracheal Intubation and Surgical Field Clarity in FESS, run by Zagazig 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 7 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: finished, as of the sponsor's last update on 6 May 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change in the mean arterial pressure measured in mmHg. (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 6 May 2026.