Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04203368 |
| Other study ID # |
FMASU R 62/ 2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2020 |
| Est. completion date |
November 22, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This prospective study was conducted in 268 patients aged from 65-70 years posted for
coronary artery bypass grafting. Patients were randomly allocated to either adenosine or
verapamil(control) groups. In the adenosine group, patients received IV adenosine 6 mg bolus
then wait 2 minutes, if it failed to return to sinus rhythm then another 12 mg IV bolus of
adenosine was administered, if supraventricular tachycardia persisted then the patient was
shifted to verapamil. In verapamil group, patients received IV verapamil 5mg bolus slowly
over 2 minutes followed by a second IV bolus dose of 5 mg ,10 minutes after the initial dose
in case of persistence of supraventricular tachycardia (SVT). If SVT persisted, the patient
was shifted to adenosine. The efficacy of the study drug, ICU stay length, systolic blood
pressure, hospital- stay length, duration of extubation, the total dose of the study drug
used, the total cost of the study drugs and the incidence of adverse events were recorded.
Description:
Written informed consent was obtained from every patient. This prospective, double-blind,
parallel-group clinical trial was conducted in 268 patients. The following inclusion criteria
were used: (1) RCT; (2) adult (age: 65-70 years) patients with ASA physical status II and
III, scheduled for elective isolated CABG; (3) use of adenosine versus verapamil for
treatment of postoperative supraventricular tachycardia; (4) the efficacy was a mandatory
outcome measurement ; (5) Ejection fraction 50-60%; (6) Absence of any associated
comorbidities or history of myocardial infarction. Patient with impaired cerebral Perfusion,
hemodynamic instability arrhythmias other than PSVT were excluded.
Anesthesia management was standardized to minimize any effect of anesthetic type on
hemodynamics. Premedication with midazolam was limited to a maximum of 0.05 mg/kg. Anesthesia
was induced with 12 μg/kg fentanyl, 5-7 mg/kg thiopental sodium, and 0.15 mg/kg pancuronium
and was maintained with 1-2.0% isoflurane. Heart rate and blood pressure were maintained
within 20% of the baseline values. Anticoagulation was achieved with heparin 300 U/kg
administered into the right atrium to maintain an activated clotting time above 480 s.
Cardiopulmonary bypass (CPB) was conducted with non-occlusive roller pumps, membrane
oxygenators, arterial line filtration, and cold blood-enriched hyperkalemic arrest. The CPB
circuit was primed with 1.8 l lactated Ringer's solution and 50 ml of 20% mannitol.
Management of CPB included systemic hypothermia (to an esophageal temperature of 32°C) during
aortic cross-clamping, targeted mean perfusion pressure between 60 and 80 mmHg, and pump flow
rates of 2.2 l/min/m2. Myocardial protection was achieved with antegrade cold blood
cardioplegia. A 32-μm filter (Avecor Affinity, Minneapolis, MN, USA) was used in the arterial
perfusion line. Before separation from CPB, patients were warmed to 36-37°C. After separation
from CPB, heparin was neutralized with protamine sulfate and 1 mg/100 U heparin to reach an
activated clotting time within 10% of baseline. All patients were transferred to the ICU
after surgery.
Patients were randomly allocated to either adenosine or verapamil(control) groups according
to a computer-generated randomization code, with allocation ratio 1:1. Opaque sealed
envelopes were prepared according to the randomization schedule, and were opened by a
clinician not involved in any part of the study. Upon arrival at the ICU, a standardized
protocol for postoperative care was implemented for all patients by well-trained nurses
supervised 1:1and by the ICU consultants. The study medications were calculated and prepared
by ICU nurses who were not a part of the research team. Both end-point assessors of the
outcomes and patients were blinded to the study drugs. All staff were blinded to treatment
allocation excluding the ICU consultant and resident who were not part of the research team.
To ensure blinding of study drug administration, the medication vials were kept in opaque
bags. Trial bags were blinded and marked with a unique number. The allocation of trial drugs
was determined by the web-based randomization system by the allocation of the bag number.
In the adenosine group, patients received IV adenosine 6 mg bolus then wait 2 minutes, if it
failed to return to sinus rhythm then another 12 mg IV bolus of adenosine was administered,
if supraventricular tachycardia persisted then the patient was shifted to verapamil. In
verapamil group, patients received IV verapamil 5mg bolus slowly over 2 minutes followed by a
second IV bolus dose of 5 mg ,10 minutes after the initial dose in case of persistence of
supraventricular tachycardia (SVT). If SVT persisted, the patient was shifted to adenosine.
All patients were routinely extubated when deemed clinically appropriate according to the
local ICU protocol, by ICU staff, when the patient was able to maintain spontaneous breathing
for 48 h, according to normal weaning parameters, after which they were encouraged to sit on
a chair and mobilize with the assistance of health care providers in the ICU then the
physiotherapist became responsible for improving mobility and rehabilitation of the patients
till discharge from the hospital. Systolic blood pressure and heart rate were continuously
monitored during drug administration and 30 minutes after conversion to sinus rhythm.
