The Effect of Dexmedetomidine, Melatonin and Pregabalin

Study Overview
=================
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

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

Conditions
-----------------
Endoscopic Sinus Surgery

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Melatonin
* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine Group<br>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<br>* Comparison the effect of Dexmedetomidine, Melatonin and Pregabalin on hemodynamics, recovery profile and postoperative pain in patients undergoing Functional endoscopic sinus<br>|
| Active Comparator: Melatonin Group<br>This Group about 30 patients will receive 10 mg melatonin (2 tablets) one hour before starting of the operation. | Drug: Melatonin<br>* Melatonin<br>|
| Active Comparator: Pregabalin Group<br>This Group about 30 patients will receive oral pregabalin 150 mg one hour before starting of the operation.. | Drug: Pregabalin<br>* Pregabalin<br>|
| Placebo Comparator: Control Group<br>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<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| controlled pulse rate | Hemodynamics stability | From base line to 1 hour after the end of the operation | 
| controlled blood pressure | Hemodynamics stability | From base line to 1 hour after the end of the operation |