Myocardial Protection and Anesthetic Agents
The Effect of Sevoflurane-dexmedetomidine and Sevoflurane-remifentanil on Biochemical Markers During Open Heart Surgery
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of this study was to investigate the myocardial protective effects of remifentanil and dexmedetomidine in cardiac surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 18, 2015
CompletedFirst Posted
Study publicly available on registry
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedDecember 10, 2015
March 1, 2015
8 months
March 18, 2015
December 9, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
level of laktat
at 20 minutes after cross clamp, 20 minutes after removal cross clamp and 10 minutes after cardiopulmonary bypass
Level of pyruvate
at 20 minutes after cross clamp, 20 minutes after removal cross clamp and 10 minutes after cardiopulmonary bypass
level of CKMB
at 20 minutes after cross clamp, 20 minutes after removal cross clamp, 10 minutes after cardiopulmonary bypass
level of Troponin-T
at 20 minutes after cross clamp, 20 minutes after removal cross clamp, 10 minutes after cardiopulmonary bypass
Study Arms (2)
remifentanil
ACTIVE COMPARATORIn the remifentanil group, anesthesia was maintained with 0.5-1.5% sevoflurane and 0.125-0.25 μg/kg/min remifentanil infusion during surgery
dexmedetomidine
ACTIVE COMPARATORIn the dexmedetomidine group anesthesia was maintained with 0.5-1.5% sevoflurane and 0.5 μg/kg dexmedetomidine loading dose during 10 minute and then 0.3-0.9 μg/kg/min infusion.
Interventions
Eligibility Criteria
You may qualify if:
- Scheduled to open heart surgery
- American Society of Anesthesiologists (ASA) physical status of II-III
You may not qualify if:
- Emergency surgery, prior cardiac surgery, ejection fraction \< 50%, restrictive or obstructive pulmonary disease, preoperative mechanical ventilation, intra-aortic balloon pump, chronic liver and renal failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cukurova University
Adana, 01130, Turkey (Türkiye)
Related Publications (2)
Kapoor P, Mandal B, Chowdhury U, Singh S, Kiran U. Changes in myocardial lactate, pyruvate and lactate-pyruvate ratio during cardiopulmonary bypass for elective adult cardiac surgery: Early indicator of morbidity. J Anaesthesiol Clin Pharmacol. 2011 Apr;27(2):225-32. doi: 10.4103/0970-9185.81819.
PMID: 21772685BACKGROUNDTriggiani M, Simeone F, Gallorini C, Paolini G, Donatelli F, Paolillo G, Dolci A, Grossi A. Measurement of cardiac troponin T and myosin to detect perioperative myocardial damage during coronary surgery. Cardiovasc Surg. 1994 Aug;2(4):441-5.
PMID: 7953444BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant Professor
Study Record Dates
First Submitted
March 18, 2015
First Posted
April 1, 2015
Study Start
December 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
December 10, 2015
Record last verified: 2015-03