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Stress, Anxiety and Type A Personality and Analgesics

Stress, Anxiety and Type A Personality and Analgesics. Impact on Induction Time and Consumption of Analgesics During Cardiac Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02756598
Acronym
SATA-1
Enrollment
60
Registered
2016-04-29
Start date
2015-01-31
Completion date
2018-06-30
Last updated
2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative; Dysfunction Following Cardiac Surgery

Keywords

sufentanil, propofol, personality/stress test, fast-track

Brief summary

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).

Detailed description

Patients randomized and the type of induction informed to the anaesthetist 30 minutes before surgery. Patients are monitored before induction of anesthesia. Propofol is started on the randomized infusion rate. Sufentanil bolus are given according to randomization. BIS level is followed. Time to reach BIS \< 50 is monitored. BIS after 30, 60 and 90 minutes are registered. Lowest BIS during surgery are registered. Total amounts of sufentanil and propofol recorded.

Interventions

DRUGSufentanil I

bolus dose of sufentanil 1 microgram/kg

DRUGSufentanil II

bolus dose of sufentanil 0.5 microgram/kg

DRUGPropofol I

Continued dose of propofol 0.03 mg/kg/min

DRUGPropofol II

Continued dose of propofol 0.06 mg/kg/min

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Age
16 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Association between preoperative personality/stress/anxiety and time (minutes) to reach anaesthetic depth goal by bi-spectral index (BIS)Up to 30 minutesMinutes to reach BIS 50
Potential of sufentanil regime on fast-track measured by ventilation time and association with eligible discharge from intensive care unit.Up to 24 hoursPostoperative ventilation time (hours/minutes) and the association to eligible discharge from ICU.

Secondary

MeasureTime frameDescription
Sufentanil regime and association to haemodynamic parameters (blood pressures, heart rate, cardiac output, oxygenation)up to 24 hoursPerioperative changes in haemodynamic parameters (analysis of varians) of haemodynamic parameters according to sufentanil regime
Association between preoperative personality/stress/anxiety tests and postoperative care using postoperative quality scoreup to 24 hoursAssociation of preoperative tests and the postoperative ICU quality scoring
Association between preoperative personality/stress/anxiety and total amounts of sufentanil and propofolUp to 12 hoursAmounts of drugs as pr kg pr time unit of involved drugs

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026