Regional Cerebral Tissue Oxygen SaturationNCT03817112
Effect of Dexmedetomidine and Propofol on Regional Cerebral Tissue Oxygen Saturation
A study testing Dexmedetomidine Hydrochloride 0.1 MG/ML and Propofol 10 MG/ML in people with Regional Cerebral Tissue Oxygen Saturation, run by Ain Shams University at 1 site in Egypt.
Trial summary
50 patients divided into 2 groups .Group I Dexmedetomidine infusion. Group II with Propofol infusion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Cerebral Tissue Oxygen Saturation
- What is being tested?
- Dexmedetomidine Hydrochloride 0.1 MG/ML and Propofol 10 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2017to 21 Jan 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing valve surgeries
- Patients undergoing on pump coronary artery bypass grafting surgeries
Who cannot join
- emergency cases, patients with cervical spine pathology (cervical stenosis, cervical disc herniation, carotid stenosis), patients with cerebral pathology (cerebral strokes, ischemic attacks), patients with Mini Mental State Examination Score (MMSE) of 23 or less, complicated cases with prolongation of the cardiopulmonary bypass period, patients needing moderate hypothermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Continuous Propofol Versus Dexmedetomidine Infusion on Regional Cerebral Tissue Oxygen Saturation During Cardiopulmonary Bypass
50 patients divided into 2 groups
.Group I Dexmedetomidine infusion. Group II with Propofol infusion
Read the detailed description
: 50 patients anticipated for open heart surgeries were encompassed in the study. Patients were divided into 2 groups, group P (receiving propofol) and group D (receiving dexmedetomidine) during CPB. Both groups were studied for variations in right and left rScO2 as well as postoperative cognitive dysfunction using the Mini Mental State Examination Score (MMSE) test.
- Being tested
- Dexmedetomidine Hydrochloride 0.1 MG/ML, Propofol 10 MG/ML
- Keywords
- cerebral oxygen saturation, cardiopulmonary bypass, dexmedetomidine, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Hydrochloride 0.1 MG/MLDrug
Dexmedetomidine Hydrochloride 0.1 MG/ML infusion at 0.2-0.7 mcg/kg/min
Propofol 10 MG/MLDrug
Propofol 10 MG/ML infusion at 0.3 -4 mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Infusion of dexmedetomidine Receives: Drug: Dexmedetomidine Hydrochloride 0.1 MG/ML |
| Propofol | Active comparator | Propofol infusion Receives: Drug: Propofol 10 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function assessment
Mini Mental State Examination Score (MMSE) test to assess orientation to time and place with ability to speak, think and draw. with highest ability 32 and lowest o
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start15 Jun 2017
- Primary completion30 Sep 2018
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Cerebral Tissue Oxygen SaturationStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Anis Metry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817112
- Sponsor's protocol ID
- ASCSH86/17
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Propofol Versus Dexmedetomidine Infusion on Regional Cerebral Tissue Oxygen Saturation During Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT03817112
- Acronym / sponsor ID
- ASCSH86/17
- Keywords
- cerebral oxygen saturation, cardiopulmonary bypass, dexmedetomidine, propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 25 Jan 2019 (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.
50 patients divided into 2 groups
.Group I Dexmedetomidine infusion. Group II with Propofol infusion
Detailed description
: 50 patients anticipated for open heart surgeries were encompassed in the study. Patients were divided into 2 groups, group P (receiving propofol) and group D (receiving dexmedetomidine) during CPB. Both groups were studied for variations in right and left rScO2 as well as postoperative cognitive dysfunction using the Mini Mental State Examination Score (MMSE) test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine Hydrochloride 0.1 MG/MLInfusion of dexmedetomidine |
| Propofol | Active comparator | Drug: Propofol 10 MG/MLPropofol infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing valve surgeries
- Patients undergoing on pump coronary artery bypass grafting surgeries
Key exclusion criteria (1 listed)
- emergency cases, patients with cervical spine pathology (cervical stenosis, cervical disc herniation, carotid stenosis), patients with cerebral pathology (cerebral strokes, ischemic attacks), patients with Mini Mental State Examination Score (MMSE) of 23 or less, complicated cases with prolongation of the cardiopulmonary bypass period, patients needing moderate hypothermia
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 |
|---|---|---|
| Dexmedetomidine Hydrochloride 0.1 MG/MLDexmedetomidine Hydrochloride 0.1 MG/ML infusion at 0.2-0.7 mcg/kg/min | Drug | Dexmedetomidine |
| Propofol 10 MG/MLPropofol 10 MG/ML infusion at 0.3 -4 mg/kg/h | Drug | Propofol |
Primary outcome
cognitive function assessment
Time frame: 24 hours postoperative
Mini Mental State Examination Score (MMSE) test to assess orientation to time and place with ability to speak, think and draw. with highest ability 32 and lowest o
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 25 Jan 2019.
- 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 study testing Dexmedetomidine Hydrochloride 0.1 MG/ML and Propofol 10 MG/ML in people with Regional Cerebral Tissue Oxygen Saturation, 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 2 inclusion and 1 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 25 Jan 2019. 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?
cognitive function assessment (time frame: 24 hours postoperative). 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 25 Jan 2019.