Propofol-Dexmedetomine Adjunction in Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery :Effect on Anesthetic Consumption ,Perioperative Outcomes,and Early Recovery
August 29, 2026 updated by: Donia Hany Saad, Kafrelsheikh University
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
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Donia Hany Hany, MD
- Phone Number: 01014498540
- Email: doniahany1788@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients belonging to American Society of Anesthesiologists (ASA) class I or II
- patients scheduled for minimally invasive cardiac valve surgery.
Exclusion Criteria:
- 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%,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Propofol group (Group P) (control group)
|
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).
|
|
Active Comparator: Propofol dexmedetomidine group (Group PD)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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) |
Time Frame: From induction of anesthesia until discontinuation of anesthesia; total isoflurane consumption will be recorded at the end of surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 15, 2027
Study Registration Dates
First Submitted
August 15, 2026
First Submitted That Met QC Criteria
August 29, 2026
First Posted (Actual)
September 1, 2026
Study Record Updates
Last Update Posted (Actual)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 29, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Anesthesia for valve surgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.