The Effect of Dexmedetomidine, Melatonin and Pregabalin

Endoscopic Sinus Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05829148
• Other study ID #: Alaa Abdel-Khalek
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 1, 2023
• Est. completion date: November 20, 2024

Study information

• Verified date: April 2023
• Source: Egymedicalpedia
• Contact: Tarek Mounir, Professor
• Phone: +201012140880
• Email: tarekmunir99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: November 20, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patients undergoing Functional endoscopic sinus surgery (ASA I & II)

Exclusion Criteria:

• 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 ß-blocker or calcium channel blocker.

• Known allergies to any of study drugs.

• Patients refusal to the study

Related Conditions & MeSH terms

• Endoscopic Sinus Surgery

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Egypt	Al-Azhar University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,	2 hours post operative
Secondary	controlled pulse rate	Hemodynamics stability	From base line to 1 hour after the end of the operation
Secondary	controlled blood pressure	Hemodynamics stability	From base line to 1 hour after the end of the operation