Cognitive DysfunctionPhase 1/2NCT03892512
Dexmedetomidine and Esmolol Early Post Operative Cognitive Dysfunction
A Phase 1/2 study testing Esmolol Hydrochloride and Dexmedetomidine in people with Cognitive Dysfunction, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Dexmedetomidine is a highly selective α2adrenoceptor agonist recently introduced to anesthesia that produces dose dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites) without respiratory depression. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Esmolol Hydrochloride and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2019to Dec 2019
- Phase
- Phase 1/2
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aging 20-50 years ASA physical status I-II . Males , females
Who cannot join
- hypertensive patient
- Patients receiving sedatives as midazolam.
- Patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases.
- Patients with cerebrovascular diseases.
- Patients with impaired kidney function.
- Patients with history of chronic liver diseases.
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- Patients with asthma, chronic obstructive lung diseases.
- Patients with diabetes mellitus, coagulation disorders, pregnancy.
- Patients with history of allergy to the drugs used in the study or patients with substance abuse .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University Hospital
Banī Suwayf
Samaa Rashwan, MD, 0201270159125
About this study
Official title: The Effect of Dexmedetomidine and Esmolol on Early Post Operative Cognitive Dysfunction After Middle Ear Surgery Under Hypotensive Technique :Comparative , Randomized Double Blinded Study
Dexmedetomidine is a highly selective α2adrenoceptor agonist recently introduced to anesthesia that produces dose dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites) without respiratory depression.
From a pharmacokinetic perspective,dexmedetomidine has a half life of nearly 2 hours, duration of action of nearly 4 hour, and thus, a side effect profile that is shorter in duration than clonidine.
Esmolol is a cardioselective beta₁ receptor blocker with rapid onset, a very short duration of action (elimination half-life is approximately 9 minutes) , and no significant intrinsic sympathomimetic or membrane stabilising activity at therapeutic dosages
Read the detailed description
The study will be a randomized double blinded study and will be carried by the Department of Anaesthesia at Beni-Suef University Hospital after obtaining approval from local research and ethical committee. Written informed consent will be obtained from each patient before operation. Aiming to assess of the early cognitive dysfunction after controlled hypotensive anesthesia with either dexmedetomidine or esmolol during middle ear surgeries
- Conditions
- Cognitive Dysfunction
- Being tested
- Esmolol Hydrochloride, Dexmedetomidine
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmolol HydrochlorideDrug
Also called esmolol
Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride )
DexmedetomidineDrug
Also called precedex
The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex )
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomedine | Active comparator | The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex .Pfizer CO ) . Receives: Drug: Dexmedetomidine |
| esmolol | Active comparator | Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride . Baxter CO ). Receives: Drug: Esmolol Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the early cognitive dysfunction after controlled hypotensive anesthesia
mini mental state examination (MMSE) will be used for evaluation of cognitive function Data will be expressed in mean ± SD and were compared using analysis of variance (ANOVA). The significance of non-parametric data was determined using chi-square test. For all comparisons P < 0.05 was considered significant.,
Measured: MMS will performed at 1 hour, 6 and 24 hours postoperatively .The mximum score will be 30 points, a decrease of 2 or more will be considered as cognitive function decline. score less than 23 will be considered as cognitive impairmen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaa Rashwan, Beni-Suef University
- Investigators
- Samaa ak Rashwan, MD, Principal investigator, Assisstant proffesor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892512
- Sponsor's protocol ID
- Beni-Suef
- Status last verified
- Mar 2019
- First submitted
- 23 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine and Esmolol on Early Post Operative Cognitive Dysfunction After Middle Ear Surgery Under Hypotensive Technique :Comparative , Randomized Double Blinded Study
- ClinicalTrials.gov ID
- NCT03892512
- Acronym / sponsor ID
- Beni-Suef
- Conditions
- Cognitive Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Mar 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.
Dexmedetomidine is a highly selective α2adrenoceptor agonist recently introduced to anesthesia that produces dose dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites) without respiratory depression.
From a pharmacokinetic perspective,dexmedetomidine has a half life of nearly 2 hours, duration of action of nearly 4 hour, and thus, a side effect profile that is shorter in duration than clonidine.
Esmolol is a cardioselective beta₁ receptor blocker with rapid onset, a very short duration of action (elimination half-life is approximately 9 minutes) , and no significant intrinsic sympathomimetic or membrane stabilising activity at therapeutic dosages
Detailed description
The study will be a randomized double blinded study and will be carried by the Department of Anaesthesia at Beni-Suef University Hospital after obtaining approval from local research and ethical committee. Written informed consent will be obtained from each patient before operation. Aiming to assess of the early cognitive dysfunction after controlled hypotensive anesthesia with either dexmedetomidine or esmolol during middle ear surgeries
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomedine | Active comparator | Drug: DexmedetomidineThe Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex .Pfizer CO ) . |
| esmolol | Active comparator | Drug: Esmolol HydrochloridePatients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride . Baxter CO ). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aging 20-50 years ASA physical status I-II . Males , females
Key exclusion criteria (9 listed)
- hypertensive patient
- Patients receiving sedatives as midazolam.
- Patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases.
- Patients with cerebrovascular diseases.
- Patients with impaired kidney function.
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 |
|---|---|---|
| Esmolol HydrochlorideAlso: esmololPatients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride ) | Drug | esmolol |
| DexmedetomidineAlso: precedexThe Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex ) | Drug | dexmedetomedine |
Primary outcome
assess the early cognitive dysfunction after controlled hypotensive anesthesia
Time frame: MMS will performed at 1 hour, 6 and 24 hours postoperatively .The mximum score will be 30 points, a decrease of 2 or more will be considered as cognitive function decline. score less than 23 will be considered as cognitive impairmen
mini mental state examination (MMSE) will be used for evaluation of cognitive function Data will be expressed in mean ± SD and were compared using analysis of variance (ANOVA). The significance of non-parametric data was determined using chi-square test. For all comparisons P < 0.05 was considered significant.,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Samaa ak Rashwan, MD principal investigator
Assisstant proffesor of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Esmolol Hydrochloride and Dexmedetomidine in people with Cognitive Dysfunction, run by Beni-Suef 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 9 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: status not confirmed, as of the sponsor's last update on 27 Mar 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samaa ak Rashwan, MD (020120159125, samakassemrashwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the early cognitive dysfunction after controlled hypotensive anesthesia (time frame: MMS will performed at 1 hour, 6 and 24 hours postoperatively .The mximum score will be 30 points, a decrease of 2 or more will be considered as cognitive function decline. score less than 23 will be considered as cognitive impairmen). 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 27 Mar 2019.