The Effect of Dexmedetomidine, Melatonin and Pregabalin
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dexmedetomidine Group 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
Comparison the effect of Dexmedetomidine, Melatonin and Pregabalin on hemodynamics, recovery profile and postoperative pain in patients undergoing Functional endoscopic sinus
|
| Active Comparator: Melatonin Group This Group about 30 patients will receive 10 mg melatonin (2 tablets) one hour before starting of the operation. |
Drug: Melatonin
Melatonin
|
| Active Comparator: Pregabalin Group This Group about 30 patients will receive oral pregabalin 150 mg one hour before starting of the operation.. |
Drug: Pregabalin
Pregabalin
|
| Placebo Comparator: Control Group 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
Placebo
|
Outcome Measures
Primary Outcome Measures
- Pain Relieve [2 hours post operative]
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,
Secondary Outcome Measures
- controlled pulse rate [From base line to 1 hour after the end of the operation]
Hemodynamics stability
- controlled blood pressure [From base line to 1 hour after the end of the operation]
Hemodynamics stability
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients undergoing Functional endoscopic sinus surgery (ASA I & II)
Exclusion Criteria:
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Hepatic, renal, endocrinal, hematological disorders.
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BMI>30 kg/m2.
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Patients receiving magnesium supplementation, anticonvulsant drugs or antipsychotic drugs.
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Chronic use of opioids.
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Current treatment with β-blocker or calcium channel blocker.
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Known allergies to any of study drugs.
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Patients refusal to the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Al-Azhar University hospitals | Cairo | Egypt |
Sponsors and Collaborators
- Egymedicalpedia
Investigators
- Study Chair: Mohamed AbdelGawad, Assist.Prof, Al-Azhar University, Faculty of medicine for boys
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Alaa Abdel-Khalek