Propofol-Dexmedetomine Adjunction in Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery :Effect on Anesthetic Consumption ,Perioperative Outcomes,and Early Recovery

NCT07798089 — Phase 1 / Phase 2, Not yet recruiting, 60 participants, Kafrelsheikh University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Propofol-Dexmedetomine Adjunction in Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery :Effect on Anesthetic Consumption ,Perioperative Outcomes,and Early Recovery : Randomized Controlled Trial

Registry	NCT07798089
Status	Not yet recruiting
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: triple, other
Enrollment	60 (Estimated)
Sponsor	Kafrelsheikh University (Other)
Conditions	Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery
Interventions	Propofol (Astra-Zeneca), propofol and dexmetomidine (Drug)
Dates	start 2026-09-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-01-15 (estimated), first posted 2026-09-01, last updated 2026-09-01

-Summary

Propofol-Dexmedetomidine Adjunction in Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery: Effects on Anesthetic Consumption, perioperative outcomes, and Early Recovery

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Propofol group (Group P) (control group)	Active comparator	Drug: Propofol (Astra-Zeneca)
Propofol dexmedetomidine group (Group PD)	Active comparator	Drug: propofol and dexmetomidine

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 dexmetomidine (Drug): 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.

+Outcome measures

Primary outcomes

total intraoperative isoflurane consumption between propofol dexmedetomidine anesthesia and propofol anesthesia alone under entropy-guided anesthesia [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)

+Eligibility

Sex: All, ages: 25 Years to 60 Years

Inclusion Criteria:

1. patients belonging to American Society of Anesthesiologists (ASA) class I or II
2. patients scheduled for minimally invasive cardiac valve surgery.

Exclusion Criteria:

1. patient more than 60 years
2. patients having neurological/psychological disorders,
3. patient having severe systemic disorders (renal/hepatic dysfunction and severe respiratory disorder),
4. patient with history of allergy to the study drugs,
5. patient with left ventricular ejection fraction < 40%,