Nitroglycerine Versus Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension

NCT04953156 | Completed

• 1 other identifier: AP2105-50107
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood pressure values

  measurements of blood pressure

  Intraoperative period

Secondary Outcomes (1)

• Intraoperative heart rate values

  operative time

Study Arms (2)

Nitroglycerin

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

Drug: Nitroglycerin

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

Interventions

Nitroglycerin 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

Nitroglycerin

Dexmedetomidine 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.

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia
• ≥ Age 18 years.

You may not qualify if:

• patient refusal
• patients on Beta blockers
• kidney or liver function impairment
• bradycardia, any degree of heart block and severe cardiorespiratory disease

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nitroglycerin; Dexmedetomidine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Walaa Y Elsabeeny, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Pain management

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 7, 2021
• Study Start: July 3, 2021
• Primary Completion: November 20, 2022
• Study Completion: December 10, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)