HypertensionNCT04953156
Nitroglycerine Versus Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension
An observational study of Hypertension, run by National Cancer Institute, Egypt at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nitroglycerin and Dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 77 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2021to 10 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia
Who may be able to join
- Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia
- ≥ Age 18 years.
Who cannot join
- patient refusal
- patients on Beta blockers
- kidney or liver function impairment
- bradycardia, any degree of heart block and severe cardiorespiratory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Nitroglycerin, Dexmedetomidine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroglycerinDrug
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
DexmedetomidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Nitroglycerin | data of patients meeting the eligibility criteria and received nitroglycerine infusion will be retrieved from medical records. Receives: 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 Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood pressure values
measurements of blood pressure
Measured: Intraoperative period
Secondary outcomes (1)
Intraoperative heart rate values
measurements of intraoperative heart rate
Measured: operative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start3 Jul 2021
- Primary completion20 Nov 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953156
- Sponsor's protocol ID
- AP2105-50107
- Status last verified
- Jan 2023
- First submitted
- 28 Jun 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be available upon reasonable request through contacting the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Nitroglycerine Infusion and Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT04953156
- Acronym / sponsor ID
- AP2105-50107
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 3 Jul 2021 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitroglycerin | – | Drug: Nitroglycerindata of patients meeting the eligibility criteria and received nitroglycerine infusion will be retrieved from medical records. |
| Dexmedetomidine | – | Drug: Dexmedetomidinepatients 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia
Key inclusion criteria (2 listed)
- Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia
- ≥ Age 18 years.
Key exclusion criteria (4 listed)
- patient refusal
- patients on Beta blockers
- kidney or liver function impairment
- bradycardia, any degree of heart block and severe cardiorespiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitroglycerindata 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 | Drug | Nitroglycerin |
| DexmedetomidineAll 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. | Drug | Dexmedetomidine |
Primary outcome
Intraoperative blood pressure values
Time frame: Intraoperative period
measurements of blood pressure
1 secondary outcome
Intraoperative heart rate values
Time frame: operative time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No. data will be available upon reasonable request through contacting the principle investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walaa Y Elsabeeny, MD principal investigator
Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood pressure values (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.