Nitroglycerine Versus Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Nitroglycerin; Drug: Dexmedetomidine

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nitroglycerin; data of patients meeting the eligibility criteria and received nitroglycerine infusion will be retrieved from medical records.	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; patients will receive dexmedetomidine bolus dose of 1 mic/kg over 20 minutes followed by intravenous infusion of 0.2-0.7 mic/kg/hr adjusted according to each patient hemodynamic response	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood pressure values	measurements of blood pressure	Intraoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative heart rate values	measurements of intraoperative heart rate	operative time

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Walaa Y Elsabeeny, MD, Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2021
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 8, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; 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; Nitroglycerin
• Other Study ID Numbers: AP2105-50107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: data will be available upon reasonable request through contacting the principle investigator

Drug and device information, study documents

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