Stress, Anxiety and Type A Personality and Analgesics (SATA-1)

Aarhus University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative; Dysfunction Following Cardiac Surgery

Treatments: Drug: Propofol II; Drug: Sufentanil II; Drug: Sufentanil I; Drug: Propofol I

Study type: Interventional

Funder types: Other

Identifiers

NCT02756598

SATA-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex

Ages: 16 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Sufentanil I

Active Comparator group

Description:

Randomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min

Treatment:

Drug: Propofol I

Drug: Sufentanil I

Sufentanil II

Active Comparator group

Description:

Randomized arm "low" sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min

Treatment:

Drug: Sufentanil II

Drug: Propofol II