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NCT04953156 Clinical Trial

Nitroglycerine Versus Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension

Hypertension Clinical Trial

Official title:
A Comparative Study Between Nitroglycerine Infusion and Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04953156
Other study ID # AP2105-50107
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 3, 2021
Est. completion date December 10, 2022

Study information
Verified date January 2023
Source National Cancer Institute, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aim to compare the efficacy of intraoperative dexmedetomidine infusion versus Nitroglycerin infusion in cancer patients with accidental uncontrolled intraoperative elevation of blood pressure.

Description:

Nitroglycerine is a direct vessel wall vasodilator with more venodilator effect than arterial dilator effect. It is used as an anti-anginal and antihypertensive drug. On the other hand, dexmedetomidine is a highly selective alpha 2 adrenergic agonist with sympatholytic effect. This study aim to compare the efficacy of intraoperative dexmedetomidine infusion versus Nitroglycerin infusion in cancer patients with accidental uncontrolled intraoperative elevation of blood pressure.

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date December 10, 2022
Est. primary completion date November 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia - = Age 18 years. Exclusion Criteria: - patient refusal - patients on Beta blockers - kidney or liver function impairment - bradycardia, any degree of heart block and severe cardiorespiratory disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nitroglycerin
data will be retrieved from intraoperative medical records for the period from May 2020 to May 2021 for patients meeting the eligibility criteria who developed uncontrolled elevation of their blood pressure and received nitroglycerine infusion
• Dexmedetomidine
All patients who develop uncontrolled elevation of their blood pressure and meeting the eligibility criteria from July 2021 to July 2022 will receive dexmedetomidine bolus of 1mic/kg over 20 minutes and then continuous infusion of 0.2-0.7 mic/kg/hour adjusted according to each patient hemodynamic response.

Locations
Country Name City State
Egypt National Cancer Institute Cairo

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative blood pressure values measurements of blood pressure Intraoperative period
Secondary Intraoperative heart rate values measurements of intraoperative heart rate operative time
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