Health TrialsbyHealthPanel

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

ConditionsTracheal Intubation MorbidityLaryngoscopyHemodynamic Response
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age40-60
SponsorTanta University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    Nebulized Dexmedetomidine (1μg/kg)

  • Melatonin

    Drug

    Oral Melatonin tablet (5mg)

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine groupExperimental treatment 1 intervention
Group B: Melatonin groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Till the end of surgery (up to 2 hours)

Secondary outcomes

1

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.

Time frame
Till the end of surgery (up to 2 hours)
2

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.

Time frame
Till 2 hours after the surgery
3

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).

Time frame
Intraoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: