Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02756598
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Carl-Johan Jakobsen, Aarhus University Hospital

Tracking Information
First Submitted Date  ICMJE December 30, 2015
First Posted Date  ICMJE April 29, 2016
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2016)
  • Association between preoperative personality/stress/anxiety and time (minutes) to reach anaesthetic depth goal by bi-spectral index (BIS) [ Time Frame: Up to 30 minutes ]
    Minutes to reach BIS 50
  • Potential of sufentanil regime on fast-track measured by ventilation time and association with eligible discharge from intensive care unit. [ Time Frame: Up to 24 hours ]
    Postoperative ventilation time (hours/minutes) and the association to eligible discharge from ICU.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2016)
  • Sufentanil regime and association to haemodynamic parameters (blood pressures, heart rate, cardiac output, oxygenation) [ Time Frame: up to 24 hours ]
    Perioperative 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 score [ Time Frame: up to 24 hours ]
    Association of preoperative tests and the postoperative ICU quality scoring
  • Association between preoperative personality/stress/anxiety and total amounts of sufentanil and propofol [ Time Frame: Up to 12 hours ]
    Amounts of drugs as pr kg pr time unit of involved drugs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stress, Anxiety and Type A Personality and Analgesics
Official Title  ICMJE Stress, Anxiety and Type A Personality and Analgesics. Impact on Induction Time and Consumption of Analgesics During Cardiac Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Postoperative; Dysfunction Following Cardiac Surgery
Intervention  ICMJE
  • Drug: Sufentanil I
    bolus dose of sufentanil 1 microgram/kg
    Other Name: Sufenta
  • Drug: Sufentanil II
    bolus dose of sufentanil 0.5 microgram/kg
    Other Name: Sufenta
  • Drug: Propofol I
    Continued dose of propofol 0.03 mg/kg/min
    Other Name: Propofol
  • Drug: Propofol II
    Continued dose of propofol 0.06 mg/kg/min
    Other Name: Propofol
Study Arms  ICMJE
  • Active Comparator: Sufentanil I
    Randomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min
    Interventions:
    • Drug: Sufentanil I
    • Drug: Propofol I
  • Active Comparator: Sufentanil II
    Randomized arm "low" sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min
    Interventions:
    • Drug: Sufentanil II
    • Drug: Propofol II
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2016)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 16 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02756598
Other Study ID Numbers  ICMJE SATA-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carl-Johan Jakobsen, Aarhus University Hospital
Study Sponsor  ICMJE Aarhus University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aarhus University Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP