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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine Group | Active Comparator | 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 . |
|
| Melatonin Group | Active Comparator | This Group about 30 patients will receive 10 mg melatonin (2 tablets) one hour before starting of the operation. |
|
| Pregabalin Group | Active Comparator | This Group about 30 patients will receive oral pregabalin 150 mg one hour before starting of the operation.. |
|
| Control Group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Comparison the effect of Dexmedetomidine, Melatonin and Pregabalin on hemodynamics, recovery profile and postoperative pain in patients undergoing Functional endoscopic sinus |
| 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 |
| 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 |
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Inclusion Criteria:
- Patients undergoing Functional endoscopic sinus surgery (ASA I & II)
Exclusion Criteria:
- Hepatic, renal, endocrinal, hematological disorders.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tarek Mounir, Professor | Contact | +201012140880 | tarekmunir99@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed AbdelGawad, Assist.Prof | Al-Azhar University, Faculty of medicine for boys | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Azhar University hospitals | Cairo | Egypt |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008550 | Melatonin |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Melatonin | Drug | Melatonin |
|
| Pregabalin | Drug | Pregabalin |
|
| Placebo | Drug | Placebo |
|
| From base line to 1 hour after the end of the operation |
| D014363 |
| Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |