Balanced Anesthesia for Minimally Invasive Cardiac Valve SurgeryPhase 1/2NCT07798089
Propofol-Dexmedetomine Adjunction in Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery :Effect on Anesthetic Consumption ,Perioperative Outcomes,and Early Recovery
A Phase 1/2 study testing Propofol (Astra-Zeneca) and propofol and dexmetomidine in people with Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery, run by Kafrelsheikh University.
Trial summary
Propofol-Dexmedetomidine Adjunction in Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery: Effects on Anesthetic Consumption, perioperative outcomes, and Early Recovery Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery
- What is being tested?
- Propofol (Astra-Zeneca) and propofol and dexmetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 15 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients belonging to American Society of Anesthesiologists (ASA) class I or II
- patients scheduled for minimally invasive cardiac valve surgery.
Who cannot join
- patient more than 60 years
- patients having neurological/psychological disorders,
- patient having severe systemic disorders (renal/hepatic dysfunction and severe respiratory disorder),
- patient with history of allergy to the study drugs,
- patient with left ventricular ejection fraction < 40%,
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Propofol-Dexmedetomine Adjunction in Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery :Effect on Anesthetic Consumption ,Perioperative Outcomes,and Early Recovery : Randomized Controlled Trial
Propofol-Dexmedetomidine Adjunction in Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery: Effects on Anesthetic Consumption, perioperative outcomes, and Early Recovery
Read the detailed description
This prospective, randomized, double-blind study was conducted to evaluate the effect of dexmedetomidine as an adjunct to propofol-based anesthesia in patients undergoing minimally invasive cardiac valve surgery. Patients were randomly allocated to receive either dexmedetomidine or placebo in addition to standard propofol-based anesthesia. The primary outcome was total propofol consumption during surgery. Secondary outcomes included intraoperative hemodynamic parameters, anesthetic and recovery characteristics, and postoperative outcomes.
- Being tested
- Propofol (Astra-Zeneca), propofol and dexmetomidine
- Keywords
- propofol , Dexmedetomidine ,Minimally Invasive Cardiac Valve Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol (Astra-Zeneca)Drug
Thirty patients will receive a continuous infusion of propofol at a rate of 2 mg/kg/h and 50 cc 0.9% sodium chloride solution infused at a rate of 0.4 µg/kg/h (used as a placebo).
propofol and dexmetomidineDrug
patients will receive a continuous infusion of propofol at a rate of 2 mg/kg/h in addition to dexmedetomidine at a rate of 0.4 µg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group (Group P) (control group) | Active comparator | Not described Receives: Drug: Propofol (Astra-Zeneca) |
| Propofol dexmedetomidine group (Group PD) | Active comparator | Not described Receives: Drug: propofol and dexmetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
total intraoperative isoflurane consumption between propofol dexmedetomidine anesthesia and propofol anesthesia alone under entropy-guided anesthesia
Total intraoperative isoflurane consumption
Description: The total amount of isoflurane consumed during anesthesia will be compared between patients receiving propofol-dexmedetomidine anesthesia and those receiving propofol anesthesia alone under entropy-guided anesthesia. Isoflurane consumption will be assessed from induction of anesthesia until discontinuation of anesthesia and measured as the total volume consumed. (ML\MIN)
Measured: Time Frame: From induction of anesthesia until discontinuation of anesthesia; total isoflurane consumption will be recorded at the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balanced Anesthesia for Minimally Invasive Cardiac Valve SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donia Hany Saad, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798089
- Sponsor's protocol ID
- Anesthesia for valve surgery
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol-Dexmedetomine Adjunction in Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery :Effect on Anesthetic Consumption ,Perioperative Outcomes,and Early Recovery : Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07798089
- Acronym / sponsor ID
- Anesthesia for valve surgery
- Keywords
- propofol , Dexmedetomidine ,Minimally Invasive Cardiac Valve Surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 1 Sep 2026 (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.
Propofol-Dexmedetomidine Adjunction in Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery: Effects on Anesthetic Consumption, perioperative outcomes, and Early Recovery
Detailed description
This prospective, randomized, double-blind study was conducted to evaluate the effect of dexmedetomidine as an adjunct to propofol-based anesthesia in patients undergoing minimally invasive cardiac valve surgery. Patients were randomly allocated to receive either dexmedetomidine or placebo in addition to standard propofol-based anesthesia. The primary outcome was total propofol consumption during surgery. Secondary outcomes included intraoperative hemodynamic parameters, anesthetic and recovery characteristics, and postoperative outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group (Group P) (control group) | Active comparator | Drug: Propofol (Astra-Zeneca) |
| Propofol dexmedetomidine group (Group PD) | Active comparator | Drug: propofol and dexmetomidine |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients belonging to American Society of Anesthesiologists (ASA) class I or II
- patients scheduled for minimally invasive cardiac valve surgery.
Key exclusion criteria (5 listed)
- patient more than 60 years
- patients having neurological/psychological disorders,
- patient having severe systemic disorders (renal/hepatic dysfunction and severe respiratory disorder),
- patient with history of allergy to the study drugs,
- patient with left ventricular ejection fraction < 40%,
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 |
|---|---|---|
| Propofol (Astra-Zeneca)Thirty patients will receive a continuous infusion of propofol at a rate of 2 mg/kg/h and 50 cc 0.9% sodium chloride solution infused at a rate of 0.4 µg/kg/h (used as a placebo). | Drug | Propofol group (Group P) (control group) |
| propofol and dexmetomidinepatients will receive a continuous infusion of propofol at a rate of 2 mg/kg/h in addition to dexmedetomidine at a rate of 0.4 µg/kg/h. | Drug | Propofol dexmedetomidine group (Group PD) |
Primary outcome
total intraoperative isoflurane consumption between propofol dexmedetomidine anesthesia and propofol anesthesia alone under entropy-guided anesthesia
Time frame: Time Frame: From induction of anesthesia until discontinuation of anesthesia; total isoflurane consumption will be recorded at the end of surgery.
Total intraoperative isoflurane consumption Description: The total amount of isoflurane consumed during anesthesia will be compared between patients receiving propofol-dexmedetomidine anesthesia and those receiving propofol anesthesia alone under entropy-guided anesthesia. Isoflurane consumption will be assessed from induction of anesthesia until discontinuation of anesthesia and measured as the total volume consumed. (ML\MIN)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Propofol (Astra-Zeneca) and propofol and dexmetomidine in people with Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery, run by Kafrelsheikh University.
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 5 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donia Hany Hany, MD (01014498540, doniahany1788@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total intraoperative isoflurane consumption between propofol dexmedetomidine anesthesia and propofol anesthesia alone under entropy-guided anesthesia (time frame: Time Frame: From induction of anesthesia until discontinuation of anesthesia; total isoflurane consumption will be recorded at the end of surgery.). 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 1 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.