An Early Phase 1 interventional study of Dexmedetomidine and Melatonin in Endoscopic Sinus Surgery, sponsored by Egymedicalpedia. Status unknown at 1 site in Egypt. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Egymedicalpedia · Early Phase 1, Interventional, and Treatment
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
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
Egymedicalpedia is the lead sponsor of 53 studies on the registry; 13 are open to participants now.
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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 .
Drug: Dexmedetomidine
This Group about 30 patients will receive 10 mg melatonin (2 tablets) one hour before starting of the operation.
Drug: Melatonin
This Group about 30 patients will receive oral pregabalin 150 mg one hour before starting of the operation..
Drug: Pregabalin
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.
Drug: Placebo
Comparison the effect of Dexmedetomidine, Melatonin and Pregabalin on hemodynamics, recovery profile and postoperative pain in patients undergoing Functional endoscopic sinus
Melatonin
Pregabalin
Placebo
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,
Time frame: 2 hours post operative
controlled pulse rate
Hemodynamics stability
Time frame: From base line to 1 hour after the end of the operation
controlled blood pressure
Hemodynamics stability
Time frame: From base line to 1 hour after the end of the operation
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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