Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01572454
Other study ID # 2012-02-012-001
Secondary ID
Status Completed
Phase N/A
First received April 4, 2012
Last updated December 24, 2013
Start date March 2012
Est. completion date December 2012

Study information

Verified date December 2013
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients undergoing off-pump coronary artery bypass graft, and trying compare these effects with those of remifentanil infusion.


Description:

Alpha2-adrenergic agonist, dexmedetomidine, is recently used for sedation, analgesia or adjuvant to general anesthesia. Postsynaptic activation of alpha2 adrenoceptors in the central nervous system (CNS) inhibits sympathetic activity and thus can decrease blood pressure and heart rate. The blockade of sympathetic activity decrease the neuroendocrine stress response and may decrease the incidence of hypokalemia. The hypokalemia can increase the incidence of arrythmia, especially in cardiac patients. We postulated that dexmedetomidine could decrease the neuroendocrine stress response, thus decrease arrhythmia during cardiac surgery. Furthermore, dexmedetomidine have been reported to have cardioprotective effect with previous animal studies.

Therefore, the aim of the present study is to investigate whether the intraoperative dexmedetomidine infusion can reduce the incidence of hypokalemia and arrythmia, and myocardial injury in subjects undergoing off-pump coronary artery bypass graft. We are also trying to compare these effects with those of remifentanil infusion.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- Those undergoing off-pump coronary artery bypass graft during March, 2012 ~ February, 2013 in Samsung Medical Center

- Age between 20 and 70 yrs old

Exclusion Criteria:

- Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome

- Patients with recent exogenous steroid administration or previous diuretics therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)


Intervention

Drug:
Dexmedetomidine infusion
Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery
Remifentanil infusion
Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum potassium concentration serum potassium concentration at the day before anesthetic induction at 24 hour before anesthetic induction Yes
Primary serum potassium concentration 1 minutes before anesthetic induction (etomidate injection) 1 minutes before anesthetic induction Yes
Primary serum potassium concentration serum potassium concentration 20 minutes after start of anesthetic induction (at the end of anesthetic induction) 20 minutes after start of anesthetic induction Yes
Primary serum potassium concentration serum potassium concentration at 2 hour after anesthetic induction (after mammary artery dissection and graft formation) 2 hour after the start of anesthetic induction Yes
Primary serum potassium concentration serum potassium concentration at 3 hour after end of anesthetic induction (after the anastomosis of coronary graft) 3 hour after start of anesthetic induction Yes
Secondary arterial blood gas analysis results arterial blood gas analysis results 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction Yes
Secondary incidence of hypokalemia incidence of hypokalemia (serum K < 3.5) incidence of hypokalemia (serum K < 4.5) 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction Yes
Secondary hemodynamic parameters hemodynamic parameters (blood pressure, heart rate, central venous pressure, cardiac output, SvO2) 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction Yes
Secondary inotropics, vasopressor requirement inotropics, vasopressor requirement 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction No
Secondary Myocardial injury marker serum concentration of CK-MB, Troponin (i)as a marker for myocaridial injury 2, 24, 48 hour after the end of surgery No
Secondary Left ventricular function left ventricular function determined by Tei index, ejection fraction of preoperative, intraoperative, postoperative echocardiography 72 hour before, during (immediate after grafting), 72 hour after surgery No
See also
  Status Clinical Trial Phase
Completed NCT04577430 - Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period N/A
Completed NCT03220880 - Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
Completed NCT05291364 - Dexmedetomidine in Splanchnic Nerve Neurolysis N/A
Recruiting NCT05249153 - Dexmedetomidine and Sufentanil Effect in PCA on Pediatric Patients Undergoing Scoliosis Surgery N/A
Completed NCT01688648 - Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft N/A
Completed NCT05103735 - Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
Recruiting NCT06030804 - Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery N/A
Terminated NCT03253224 - Magnesium and Postoperative Pain Phase 4
Recruiting NCT06210061 - Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring N/A
Recruiting NCT05525819 - Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection N/A
Completed NCT04665453 - Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children N/A
Completed NCT06018948 - Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients Phase 4
Completed NCT03775655 - Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section Phase 2/Phase 3
Completed NCT03658421 - Dexmedetomidine as Adjuvant for FNB in TKA N/A
Completed NCT03234660 - Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia N/A
Completed NCT06020781 - Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block N/A
Recruiting NCT06207331 - Effects of Atomized Dexmedetomidine on Lung Function in Patients With Chronic Obstructive Pulmonary Disease N/A
Active, not recruiting NCT03629262 - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery Phase 4
Completed NCT06098209 - Dexmedetomidine and Propofol in Mechanically Ventilated Patients by Using Salivary Alpha-amylase as a Stress Marker N/A
Not yet recruiting NCT06062550 - Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery Phase 4