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

A

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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