Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial
— SATA-1Official title:
Stress, Anxiety and Type A Personality and Analgesics. Impact on Induction Time and Consumption of Analgesics During Cardiac Surgery
NCT number | NCT02756598 |
Other study ID # | SATA-1 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | June 30, 2018 |
Verified date | July 2019 |
Source | Aarhus University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients scheduled for elective cardiac surgery are preoperative evaluated using different
personality type, stress and anxiety tests.
Patient are randomized to receive the investigators' standard moderate dose sufentanil (bolus
1microgram/kg and propofol 0.03 mg/kg/min) or low dose sufentanil (bolus 0.5 microgram/kg and
propofol 0.06 mg/kg/min).
Status | Completed |
Enrollment | 60 |
Est. completion date | June 30, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 90 Years |
Eligibility |
Inclusion Criteria: - All elective cardiac surgery patients Exclusion Criteria: - Patients requiring special attention or monitoring during induction - Patients with expected longer postoperative ventilation time - Patients allergic to sufentanil and or propofol - Participation in other projects - Pregnancy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Association between preoperative personality/stress/anxiety and time (minutes) to reach anaesthetic depth goal by bi-spectral index (BIS) | Minutes to reach BIS 50 | Up to 30 minutes | |
Primary | Potential of sufentanil regime on fast-track measured by ventilation time and association with eligible discharge from intensive care unit. | Postoperative ventilation time (hours/minutes) and the association to eligible discharge from ICU. | Up to 24 hours | |
Secondary | Sufentanil regime and association to haemodynamic parameters (blood pressures, heart rate, cardiac output, oxygenation) | Perioperative changes in haemodynamic parameters (analysis of varians) of haemodynamic parameters according to sufentanil regime | up to 24 hours | |
Secondary | Association between preoperative personality/stress/anxiety tests and postoperative care using postoperative quality score | Association of preoperative tests and the postoperative ICU quality scoring | up to 24 hours | |
Secondary | Association between preoperative personality/stress/anxiety and total amounts of sufentanil and propofol | Amounts of drugs as pr kg pr time unit of involved drugs | Up to 12 hours |
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