Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Melatonin.
- Who it may be relevant to
- Registry conditions: Tracheal Intubation Morbidity, Laryngoscopy, Hemodynamic Response. Basic parameters: 40 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Study Between Oral Melatonin and Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients: A Prospective Randomized Trial
Overview
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
Detailed description
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.
Interventions
- Drug Dexmedetomidine
Nebulized Dexmedetomidine (1μg/kg) - Drug Melatonin
Oral Melatonin tablet (5mg)
Primary outcome measures
- Change in Heart Rate (HR) [Time frame: Till the end of surgery (up to 2 hours)]
Secondary outcome measures (3)
- Change in Systolic and Diastolic blood pressure [Time frame: Till the end of surgery (up to 2 hours)]
- Sedation levels using Ramsay Sedation Scale [Time frame: Till 2 hours after the surgery]
- Intraoperative requirement of fentanyl [Time frame: Intraoperatively]
Eligibility criteria
Inclusion criteria
- Age (40-60) years of both genders.
- Controlled hypertensive patients.
- Categorized as ASA physical status II.
- Planning to do an elective surgery under General Anesthesia.
Exclusion criteria
- Patient refusal to participate in the study.
- Patient with expected difficult intubation.
- Body Mass Index (BMI) > 30 kg/m2.
- History of allergy to the drugs of the study.
- Patients with Heart rate<50 or Heart block.
- End stage renal and hepatic disease.
- Patients on beta blocker, oral hypoglycemics, anti-depressants, anti-convulsants, anti- psychotics and thyroid medications.
- Pregnant or lactating females.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Tanta University Hospital — Tanta
Identifiers
NCT: NCT06935292 · 36264MS867/3/25