Nitroglycerine Versus Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension

NCT ID: NCT04953156

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-03
• Study Completion Date: 2022-12-10

Brief 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.

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.

Conditions

Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Nitroglycerin

data of patients meeting the eligibility criteria and received nitroglycerine infusion will be retrieved from medical records.

Nitroglycerin

Intervention Type: DRUG

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

Dexmedetomidine

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Walaa Youssef Elsabeeny

Lecturer of Anesthesia and Pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Walaa Y Elsabeeny, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University

Locations

National Cancer Institute

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AP2105-50107

Identifier Type: -

Identifier Source: org_study_id