Endoscopic Sinus SurgeryEarly Phase 1NCT05829148
The Effect of Dexmedetomidine, Melatonin and Pregabalin
A Early Phase 1 study testing Dexmedetomidine, Melatonin and Pregabalin in people with Endoscopic Sinus Surgery, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Various drugs have been used for the purpose: nitroglycerine, sodium nitroprusside, propofol, beta blockers, calcium channel blockers, higher concentrations of inhalational anesthetics etc. Since all these drugs have certain limitations there was a search for more safe and effective drug Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Endoscopic Sinus Surgery
- What is being tested?
- Dexmedetomidine, Melatonin and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 20 Nov 2024
- Phase
- Early Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing Functional endoscopic sinus surgery (ASA I \& II)
Who cannot join
- Hepatic, renal, endocrinal, hematological disorders.
- BMI>30 kg/m2.
- Patients receiving magnesium supplementation, anticonvulsant drugs or antipsychotic drugs.
- Chronic use of opioids.
- Current treatment with β-blocker or calcium channel blocker.
- Known allergies to any of study drugs.
- Patients refusal to the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Al-Azhar University hospitals
Cairo
Alaa Abdel-Khalek, MSc, 01066080219, alaa83eg7@yahoo.com
Mohamed Abdel-Gawad, Assist.Prof., 01091945931, abosoad.mohamed2017@gmail.com
About this study
Official title: Comparison Between the Effect of Dexmedetomidine, Melatonin and Pregabalin on Hypotensive Anesthesia in Patients Undergoing Functional Endoscopic Sinus Surgery
Various drugs have been used for the purpose: nitroglycerine, sodium nitroprusside, propofol, beta blockers, calcium channel blockers, higher concentrations of inhalational anesthetics etc. Since all these drugs have certain limitations there was a search for more safe and effective drug
Read the detailed description
Functional Endoscopic Sinus Surgery (FESS) is done via endoscope and the area is highly vascular thus it becomes important to minimize bleeding, hence we require hypotensive anesthesia.
Dexmedetomidine (a highly selective α2-receptor agonist that has sedative, analgesic, anxiolytic, and opioid sparing effects without significant respiratory depression) it also reduces the need for inhaled anesthetics. dexmedetomidine also minimizes postoperative opioid consumption as well as nausea, vomiting, and anxiety.
Melatonin is a neurohormone mainly secreted from the pineal gland by the suprachiasmatic nucleus. It possesses a circadian secretion pattern and regulates the biological clock; it also offers antiemetic, analgesic, and anxiolytic effects. Due to its effect on both acute and chronic pain, melatonin (available in 5mg tablet form) fulfills a beneficial role in reducing postoperative opioid consumption while minimizing nausea and vomiting.
Pregabalin, whose structure is similar to the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), possesses analgesic and anxiolytic activities and is effective in alleviating the neuropathic component of acute nociceptive pain of surgery. It has also been used as premedication to attenuate the hemodynamic stress response to laryngoscopy and intubation and to decrease intraoperative anesthetic requirement
- Conditions
- Endoscopic Sinus Surgery
- Being tested
- Dexmedetomidine, Melatonin, Pregabalin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Comparison the effect of Dexmedetomidine, Melatonin and Pregabalin on hemodynamics, recovery profile and postoperative pain in patients undergoing Functional endoscopic sinus
MelatoninDrug
Melatonin
PregabalinDrug
Pregabalin
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Active comparator | This Group about 30 patients will receive dexmedetomidine loading dose 1 µg/kg over a period of 15 minutes and maintenance 0.2µg/kg/h throughout the surgery . Receives: Drug: Dexmedetomidine |
| Melatonin Group | Active comparator | This Group about 30 patients will receive 10 mg melatonin (2 tablets) one hour before starting of the operation. Receives: Drug: Melatonin |
| Pregabalin Group | Active comparator | This Group about 30 patients will receive oral pregabalin 150 mg one hour before starting of the operation.. Receives: Drug: Pregabalin |
| Control Group | Placebo comparator | This Group about 30 patients will receive oral starch tablet as a control. Heart rate (HR) and blood pressure values will be recorded at various intervals. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relieve
Assessment of the pain post-operatively in patients with pain score by VAS as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain,
Measured: 2 hours post operative
Secondary outcomes (2)
controlled pulse rate
Hemodynamics stability
Measured: From base line to 1 hour after the end of the operation
controlled blood pressure
Hemodynamics stability
Measured: From base line to 1 hour after the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Sinus SurgeryStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamed AbdelGawad, Assist.Prof, Study chair, Al-Azhar University, Faculty of medicine for boys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829148
- Sponsor's protocol ID
- Alaa Abdel-Khalek
- Status last verified
- Apr 2023
- First submitted
- 8 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Dexmedetomidine, Melatonin and Pregabalin on Hypotensive Anesthesia in Patients Undergoing Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT05829148
- Acronym / sponsor ID
- Alaa Abdel-Khalek
- Conditions
- Endoscopic Sinus Surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 25 Apr 2023 (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.
Various drugs have been used for the purpose: nitroglycerine, sodium nitroprusside, propofol, beta blockers, calcium channel blockers, higher concentrations of inhalational anesthetics etc. Since all these drugs have certain limitations there was a search for more safe and effective drug
Detailed description
Functional Endoscopic Sinus Surgery (FESS) is done via endoscope and the area is highly vascular thus it becomes important to minimize bleeding, hence we require hypotensive anesthesia.
Dexmedetomidine (a highly selective α2-receptor agonist that has sedative, analgesic, anxiolytic, and opioid sparing effects without significant respiratory depression) it also reduces the need for inhaled anesthetics. dexmedetomidine also minimizes postoperative opioid consumption as well as nausea, vomiting, and anxiety.
Melatonin is a neurohormone mainly secreted from the pineal gland by the suprachiasmatic nucleus. It possesses a circadian secretion pattern and regulates the biological clock; it also offers antiemetic, analgesic, and anxiolytic effects. Due to its effect on both acute and chronic pain, melatonin (available in 5mg tablet form) fulfills a beneficial role in reducing postoperative opioid consumption while minimizing nausea and vomiting.
Pregabalin, whose structure is similar to the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), possesses analgesic and anxiolytic activities and is effective in alleviating the neuropathic component of acute nociceptive pain of surgery. It has also been used as premedication to attenuate the hemodynamic stress response to laryngoscopy and intubation and to decrease intraoperative anesthetic requirement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Drug: DexmedetomidineThis Group about 30 patients will receive dexmedetomidine loading dose 1 µg/kg over a period of 15 minutes and maintenance 0.2µg/kg/h throughout the surgery . |
| Melatonin Group | Active comparator | Drug: MelatoninThis Group about 30 patients will receive 10 mg melatonin (2 tablets) one hour before starting of the operation. |
| Pregabalin Group | Active comparator | Drug: PregabalinThis Group about 30 patients will receive oral pregabalin 150 mg one hour before starting of the operation.. |
| Control Group | Placebo comparator | Drug: PlaceboThis Group about 30 patients will receive oral starch tablet as a control. Heart rate (HR) and blood pressure values will be recorded at various intervals. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing Functional endoscopic sinus surgery (ASA I \& II)
Key exclusion criteria (7 listed)
- Hepatic, renal, endocrinal, hematological disorders.
- BMI>30 kg/m2.
- Patients receiving magnesium supplementation, anticonvulsant drugs or antipsychotic drugs.
- Chronic use of opioids.
- Current treatment with β-blocker or calcium channel blocker.
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 |
|---|---|---|
| DexmedetomidineComparison the effect of Dexmedetomidine, Melatonin and Pregabalin on hemodynamics, recovery profile and postoperative pain in patients undergoing Functional endoscopic sinus | Drug | Dexmedetomidine Group |
| MelatoninMelatonin | Drug | Melatonin Group |
| PregabalinPregabalin | Drug | Pregabalin Group |
| PlaceboPlacebo | Drug | Control Group |
Primary outcome
Pain Relieve
Time frame: 2 hours post operative
Assessment of the pain post-operatively in patients with pain score by VAS as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain,
2 secondary outcomes
controlled pulse rate
Time frame: From base line to 1 hour after the end of the operation
controlled blood pressure
Time frame: From base line to 1 hour after the end of the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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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. This study is not recruiting at the moment.
Mohamed AbdelGawad, Assist.Prof study chair
Al-Azhar University, Faculty of medicine for boys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexmedetomidine, Melatonin and Pregabalin in people with Endoscopic Sinus Surgery, run by Egymedicalpedia 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tarek Mounir, Professor (+201012140880, tarekmunir99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relieve (time frame: 2 hours post operative). 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 25 Apr 2023.