The Effect of Dexmedetomidine, Melatonin and Pregabalin
NCT ID: NCT05829148
Last Updated: 2023-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
120 participants
INTERVENTIONAL
2023-05-01
2024-11-20
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dexmedetomidine Group
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 .
Dexmedetomidine
Comparison the effect of Dexmedetomidine, Melatonin and Pregabalin on hemodynamics, recovery profile and postoperative pain in patients undergoing Functional endoscopic sinus
Melatonin Group
This Group about 30 patients will receive 10 mg melatonin (2 tablets) one hour before starting of the operation.
Melatonin
Melatonin
Pregabalin Group
This Group about 30 patients will receive oral pregabalin 150 mg one hour before starting of the operation..
Pregabalin
Pregabalin
Control Group
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.
Placebo
Placebo
Interventions
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Dexmedetomidine
Comparison the effect of Dexmedetomidine, Melatonin and Pregabalin on hemodynamics, recovery profile and postoperative pain in patients undergoing Functional endoscopic sinus
Melatonin
Melatonin
Pregabalin
Pregabalin
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
21 Years
55 Years
ALL
No
Sponsors
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Egymedicalpedia
INDUSTRY
Responsible Party
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Principal Investigators
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Mohamed AbdelGawad, Assist.Prof
Role: STUDY_CHAIR
Al-Azhar University, Faculty of medicine for boys
Locations
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Al-Azhar University hospitals
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Alaa Abdel-Khalek
Identifier Type: -
Identifier Source: org_study_id
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