Effect of Drug in CABAG PatientsEarly Phase 1CABAGNCT05778305

Effect of Dexmedetomidine on Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome

A Early Phase 1 study testing Dexmedetomidine and normal saline in people with Effect of Drug in CABAG Patients, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

50 patients of both sexes undergoing elective CABG surgery will be randomly divided into 2 groups, study group (Dex) group and control group (C) to determine the effect of dexmedetomidine on the peri-operative hemodynamic changes during CABG surgery. Read more about this study

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Effect of Drug in CABAG Patients
What is being tested?: Dexmedetomidine and normal saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteEgypt
Study dates: 29 Jan 2023to 31 Dec 2023
Phase: Early Phase 1
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 30 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

undergoing elective CABG surgery

Who cannot join

Patient refusal
Dementia patients
Poor ventricular function with ejection fraction below 40%
Asthmatic patients
Uncontrolled diabetic patients with HbA1c above 8
Combined surgeries (CABG+ valves)

Show all 12Show fewer

Emergency surgeries.
Pre-existing arrhythmia
Patients with renal impairment
Patients with hepatic impairment
Patients with heart block
Off-pump CABG

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Ain Shams University
Cairo, Abassia

Other trials in Egypt

About this study

Official title: Effect of Dexmedetomidine on Stress-induced Changes in Hemodynamics and Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome

Read the detailed description

The effect of dexmedetomidine during CABG surgery is studied regarding Ventricular function, pre bypass and post bypass using the transoeophageal echo (TEE), post-operative by transthoracic echocardiography (TTE) on day of surgery and after extubation.

Incidence of intraoperative and post operative ischemia and arrhythmias using Electrocardiogram (ECG) as well as the length of ICU and hospital stay.

Conditions: Effect of Drug in CABAG Patients
Being tested: Dexmedetomidine, normal saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Also called precedex
a central sympatholytic drug
normal salineOther
Also called saline
saline is given to control group

Study groups in NCT05778305
Study group	Role	What they receive
Dexmedetomidine group	Active comparator	patients will have loading Dexmedetomidine( 1ug/kg) over 10 minutes followed by continuous infusion of (0.5ug/kg/hr) from the initiation of anaesthesia up to extubation in the ICU. Patients will not be extubated until completely awake and have no sign of arrhythmias and bleeding Receives: Drug: Dexmedetomidine
control group	Placebo comparator	patients will receive the same volume of 0.9% saline infusion as loading and maintenance infusion. Receives: Other: normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Intra-operative ventricular function.
global systolic function Ejection Fraction by TEE intraoperative
Measured: Intraoperative
post-operative ventricular function.
global systolic function Ejection Fraction by TTE postoperative
Measured: Up to 24 hours postoperative

Secondary outcomes (2)

hemodynamics
Heart Rate (beat/minute),
Measured: Immediate postoperative and up to 24 hours postoperative
hemodynamics
Mean arterial blood pressure (mmHg)
Measured: Immediate postoperative and up to 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 202331 Dec 2023

First posted21 Mar 2023
Study start29 Jan 2023
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Effect of Drug in CABAG PatientsStudies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
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: Interventional
Phase: Early Phase 1
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05778305
Sponsor's protocol ID: FMASU MD283/2022
Acronym: CABAG
Status last verified: Oct 2024
First submitted: 29 Jan 2023
Last updated: 9 Oct 2024
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Dexmedetomidine on Stress-induced Changes in Hemodynamics and Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome
ClinicalTrials.gov ID: NCT05778305
Acronym / sponsor ID: CABAG / FMASU MD283/2022
Conditions: Effect of Drug in CABAG Patients
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: 29 Jan 2023 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 21 Mar 2023 (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.

Detailed description

Incidence of intraoperative and post operative ischemia and arrhythmias using Electrocardiogram (ECG) as well as the length of ICU and hospital stay.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dexmedetomidine group	Active comparator	Drug: Dexmedetomidinepatients will have loading Dexmedetomidine( 1ug/kg) over 10 minutes followed by continuous infusion of (0.5ug/kg/hr) from the initiation of anaesthesia up to extubation in the ICU. Patients will not be extubated until completely awake and have no sign of arrhythmias and bleeding
control group	Placebo comparator	Other: normal salinepatients will receive the same volume of 0.9% saline infusion as loading and maintenance infusion.

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

undergoing elective CABG surgery

Key exclusion criteria (12 listed)

Patient refusal

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
DexmedetomidineAlso: precedexa central sympatholytic drug	Drug	Dexmedetomidine group
normal salineAlso: salinesaline is given to control group	Other	control group

Primary outcome

Intra-operative ventricular function.
Time frame: Intraoperative
global systolic function Ejection Fraction by TEE intraoperative
post-operative ventricular function.
Time frame: Up to 24 hours postoperative
global systolic function Ejection Fraction by TTE postoperative

2 secondary outcomes

hemodynamics
Time frame: Immediate postoperative and up to 24 hours postoperative
hemodynamics
Time frame: Immediate postoperative and up to 24 hours postoperative

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 9 Oct 2024.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Dexmedetomidine and normal saline in people with Effect of Drug in CABAG Patients, run by Ain Shams University 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 1 inclusion and 12 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 9 Oct 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Intra-operative ventricular function. (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05778305.

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 9 Oct 2024.