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The aim of this study is to compare the efficacy of oral melatonin versus nebulized dexmedetomidine in attenuating the hemodynamic response to direct laryngoscopy and endotracheal intubation in controlled hypertensive patients prepared for general anesthesia
Laryngoscopy and endotracheal intubation are associated with sympathetic stimulation and induce hemodynamic changes with consequent increase in heart rate (HR) and blood pressure (BP) which may lead to myocardial infarction, cardiac arrhythmias, cardiac failure and cerebrovascular accidents in patients with underlying cardiovascular or cerebrovascular diseases.
Dexmedetomidine is a centrally acting α-2 adrenergic agonist with sedative, hypnotic, analgesic, anxiolytic, anti-sialagogue, antinociceptive and sympatholytic action. Premedication with dexmedetomidine through intravenous, intramuscular and intranasal route has been shown to effectively attenuate hemodynamic response to laryngoscopy and endotracheal intubation. Nebulization provides an alternative route of dexmedetomidine premedication with high bioavailability through both nasal (65%) and oral mucosa (82%) and avoids a venipuncture as a prerequisite. Recent studies have shown nebulization as a novel route of dexmedetomidine administration for attenuation of hemodynamic response to endotracheal intubation.
Melatonin is a natural substance produced mainly in the pineal gland of all mammals and vertebrates. It is rapidly distributed and eliminated after intravenous administration. After oral administration, plasma concentration peaks after 60 min and is then eliminated. It exerts its hypnotic effects through the activation of the Melatonin receptors type I and II (MT1, MT2). It has shown potent analgesic effects in a dose dependent manner in experimental studies. It may induce relaxation of the arterial wall smooth muscle by increasing nitric oxide levels. Therefore, premedication with sublingual/oral Melatonin is associated with pre-operative anxiolysis and sedation without impairment of orientation, psychomotor skills, or impact on quality of recovery, moreover, it attenuates the hemodynamic stress response to laryngoscopy and tracheal intubation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | Participants in this group will receive nebulized dexmedetomidine (1μg/kg) one hour before induction of anesthesia |
|
| Melatonin group | Experimental | Participants in this group will receive melatonin oral tablet (5mg) one hour before induction of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Nebulized Dexmedetomidine (1μg/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate (HR) | Heart Rate will be assessed using pulse oximeter in pre-operative room (baseline), before the induction of anesthesia, immediately before laryngescopy or intubation, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, every 30 minutes till the end of operation. | Till the end of surgery (up to 2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic and Diastolic blood pressure | Systolic and diastolic blood pressure will be recorded in pre-operative room (baseline), before the induction of anesthesia, immediately before laryngescopy or intubation, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, every 30 minutes till the end of operation. | Till the end of surgery (up to 2 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aya GAE Ismaeil, MBBCH | Contact | +201159716507 | ayagamal9009@gmail.com | |
| Alaa MF Abo Hagar, PHD | Contact | +201099220281 | alaa.abohagar@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Aya GAE Ismaeil, MBBCH | Faculty of Medicine, Tanta University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospital | Tanta | El-Gharbia Govenorate | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author
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Dexmedetomidine will be given in the form of nebulized dexmedetomidine (1μg/kg) one hour before induction of anesthesia.
Melatonin will be given as melatonin oral tablet (5mg) one hour before induction of anesthesia.
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A Research nurse who will not participate in the evaluation of sedation will give the drugs to all patients 60 minute before induction of general anesthesia. Outcome assessment will be conducted by an anesthesiologist who will be blinded
| Melatonin | Drug | Oral Melatonin tablet (5mg) |
|
|
| Sedation levels using Ramsay Sedation Scale | Sedation levels will be assessed using Ramsay Sedation Scale (1, Anxious and agitated, restless, or both; 2, Cooperative, oriented, and calm; 3 Responsive to commands only; 4 Exhibiting brisk response to light glabellar tap or loud auditory stimulus; 5, Exhibiting a sluggish response to light glabellar tap or loud auditory stimulus; 6, Unresponsive) before administration of the study drugs, before induction of anesthesia (60 minutes after drug taken), every 30 minutes post operative till 2 hours after surgery. | Till 2 hours after the surgery |
| Intraoperative requirement of fentanyl | Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain). | Intraoperatively |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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