Clinical trial NCT06935292: Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Tracheal Intubation Morbidity
Laryngoscopy
Hemodynamic Response
Keywords: Direct laryngoscope
Dexmedetomidine
Melatonin
Tracheal Intubation
Hypertension
Hemodynamic response
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: Change in Heart Rate (HR)
timeFrame: Till the end of surgery (up to 2 hours)
Secondary outcomes:
measure: Change in Systolic and Diastolic blood pressure
timeFrame: Till the end of surgery (up to 2 hours)
measure: Sedation levels using Ramsay Sedation Scale
timeFrame: Till 2 hours after the surgery
measure: Intraoperative requirement of fentanyl
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: El-Gharbia Govenorate
Study officials:
affiliation: Faculty of Medicine, Tanta University, Egypt
name: Aya GAE Ismaeil, MBBCH
role: PRINCIPAL_INVESTIGATOR
References: