NCT05829148

The Effect of Dexmedetomidine, Melatonin and Pregabalin

Comparison Between the Effect of Dexmedetomidine, Melatonin and Pregabalin on Hypotensive Anesthesia in Patients Undergoing Functional Endoscopic Sinus Surgery

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Egymedicalpedia · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Comparison the effect of Dexmedetomidine, Melatonin and Pregabalin on hemodynamics, recovery profile and postoperative pain in patients undergoing Functional endoscopic sinus
DRUG	Melatonin	Melatonin
DRUG	Pregabalin	Pregabalin
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-11-01
• Completion: 2024-11-20
• First posted: 2023-04-25
• Last updated: 2023-04-25

Locations

1 site across 1 country: Egypt