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

NCT06935292 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 36264MS867/3/25
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Tracheal Intubation Morbidity; Laryngoscopy; Hemodynamic Response

Keywords

Direct laryngoscope; Dexmedetomidine; Melatonin; Tracheal Intubation; Hypertension; Hemodynamic response

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Change in Systolic and Diastolic blood pressure

  Till the end of surgery (up to 2 hours)

• Sedation levels using Ramsay Sedation Scale

  Till 2 hours after the surgery

• Intraoperative requirement of fentanyl

  Intraoperatively

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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

Drug: Dexmedetomidine

Melatonin group

EXPERIMENTAL

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

Drug: Melatonin

Interventions

Dexmedetomidine DRUG

Nebulized Dexmedetomidine (1μg/kg)

Also known as: Precedex

Dexmedetomidine group

Melatonin DRUG

Oral Melatonin tablet (5mg)

Also known as: Circadin

Melatonin group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, El-Gharbia Govenorate, 31527, Egypt

Location

MeSH Terms

Conditions

Hypertension

Interventions

Dexmedetomidine; Melatonin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Aya GAE Ismaeil, MBBCH

  Faculty of Medicine, Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aya GAE Ismaeil, MBBCH

CONTACT

+201159716507; ayagamal9009@gmail.com

Alaa MF Abo Hagar, PHD

CONTACT

+201099220281; alaa.abohagar@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Management

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 20, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)