Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients

NCT ID: NCT06935292

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-04-30

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.

Conditions

Tracheal Intubation Morbidity; Laryngoscopy; Hemodynamic Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine group

Participants in this group will receive nebulized dexmedetomidine (1μg/kg) one hour before induction of anesthesia

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Nebulized Dexmedetomidine (1μg/kg)

Melatonin group

Participants in this group will receive melatonin oral tablet (5mg) one hour before induction of anesthesia

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DRUG

Oral Melatonin tablet (5mg)

Interventions

Dexmedetomidine

Nebulized Dexmedetomidine (1μg/kg)

Intervention Type: DRUG

Melatonin

Oral Melatonin tablet (5mg)

Intervention Type: DRUG

Other Intervention Names

Precedex; Circadin

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Aya Gamal Abo Elfotoh Ismaeil

Resident of Anesthesia, Surgical Intensive Care and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aya GAE Ismaeil, MBBCH

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Tanta University, Egypt

Locations

Tanta University Hospital

Tanta, El-Gharbia Govenorate, Egypt

Countries

Egypt

Central Contacts

Aya GAE Ismaeil, MBBCH

Role: CONTACT

ayagamal9009@gmail.com

+201159716507

Alaa MF Abo Hagar, PHD

Role: CONTACT

alaa.abohagar@med.tanta.edu.eg

+201099220281

Other Identifiers

36264MS867/3/25

Identifier Type: -

Identifier Source: org_study_id