Clinical trial NCT05829148: The Effect of Dexmedetomidine, Melatonin and Pregabalin
Official title: Comparison Between the Effect of Dexmedetomidine, Melatonin and Pregabalin on Hypotensive Anesthesia in Patients Undergoing Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Endoscopic Sinus Surgery
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2023-04-25
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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 β-blocker or calcium channel blocker.
* Known allergies to any of study drugs.
* Patients refusal to the study

Primary outcomes:
measure: Pain Relieve
timeFrame: 2 hours post operative
Secondary outcomes:
measure: controlled pulse rate
timeFrame: From base line to 1 hour after the end of the operation
measure: controlled blood pressure
timeFrame: From base line to 1 hour after the end of the operation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University hospitals
Study officials:
affiliation: Al-Azhar University, Faculty of medicine for boys
name: Mohamed AbdelGawad, Assist.Prof
role: STUDY_CHAIR
References: