Nitroglycerine Versus Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension

Sponsor

National Cancer Institute, Egypt (Other)

Overall Status

Recruiting

CT.gov ID

NCT04953156

Collaborator

(none)

Enrollment

Location

13.2

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 3, 2021

Anticipated Primary Completion Date :

Jul 15, 2022

Anticipated Study Completion Date :

Aug 10, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Intraoperative blood pressure values [Intraoperative period]
measurements of blood pressure

Secondary Outcome Measures

Intraoperative heart rate values [operative time]
measurements of intraoperative heart rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Institute	Cairo		Egypt	11796

Sponsors and Collaborators

National Cancer Institute, Egypt

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Walaa Youssef Elsabeeny, Lecturer of Anesthesia and Pain management, National Cancer Institute, Egypt

ClinicalTrials.gov Identifier:

NCT04953156

Other Study ID Numbers:

AP2105-50107

First Posted:

Jul 7, 2021

Last Update Posted:

Jun 21, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Nitroglycerin

Dexmedetomidine

Study Results

No Results Posted as of Jun 21, 2022