Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.

Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients

Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.

Study Overview

• Status: Completed
• Conditions: Stress Response During Laryngoscopy Intubation
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: sterile saline

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• - Age group 20-60 years
• ASA grade 1 and 2
• control hypertensive patients.

Exclusion Criteria:

• - Consent not given
• ASA Grade 3 and 4
• history of myocardial ischemia or infarction, or had an abnormal ECG on admission to the hospital
• Patients with cardiovascular, pulmonary, hepatic, and renal disease.
• Patients on B blockers.
• patients with difficult airway; laryngoscopy and intubation time more than 20 s, or requiring more than two attempts will be exclude from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine group; 35 patients will receive dexmedetomidine 0.5 µg/kg was administered intravenously using a syringe pump over 10 min sterile saline pre-induction of anesthesia.	Drug: Dexmedetomidine; Dexmedetomidine preinduction
Placebo Comparator: Control group; 35 patients will receive sterile saline 0.5 µg/kg was administered intravenously using a syringe pump over 10 min pre-induction of anesthesia.	Drug: sterile saline; normal saline preinduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
heart rate	through first 15 min post-induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Time Frame
systolic blood pressure	through first 15 min post-induction of anesthesia
diastolic blood pressure	through first 15 min post-induction of anesthesia

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): March 8, 2020
• Study Completion (Actual): March 12, 2020

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): June 29, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 01003060483

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No