The Effect of Dexmedetomidine, Melatonin and Pregabalin

Egymedicalpedia

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Endoscopic Sinus Surgery

Treatments: Drug: Pregabalin; Drug: Melatonin; Drug: Dexmedetomidine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05829148

Alaa Abdel-Khalek

Details and patient eligibility

About

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

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups, including a placebo group

Dexmedetomidine Group

Active Comparator group

Description:

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 .

Treatment:

Drug: Dexmedetomidine

Melatonin Group

Active Comparator group

Description:

This Group about 30 patients will receive 10 mg melatonin (2 tablets) one hour before starting of the operation.

Treatment:

Drug: Melatonin

Pregabalin Group

Active Comparator group

Description:

This Group about 30 patients will receive oral pregabalin 150 mg one hour before starting of the operation..

Treatment:

Drug: Pregabalin

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo