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

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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

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).


Condition or disease Intervention/treatment Phase
Postoperative; Dysfunction Following Cardiac Surgery Drug: Sufentanil I Drug: Sufentanil II Drug: Propofol I Drug: Propofol II Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Stress, Anxiety and Type A Personality and Analgesics. Impact on Induction Time and Consumption of Analgesics During Cardiac Surgery
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sufentanil I
Randomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min
Drug: Sufentanil I
bolus dose of sufentanil 1 microgram/kg
Other Name: Sufenta

Drug: Propofol I
Continued dose of propofol 0.03 mg/kg/min
Other Name: Propofol

Active Comparator: Sufentanil II
Randomized arm "low" sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min
Drug: Sufentanil II
bolus dose of sufentanil 0.5 microgram/kg
Other Name: Sufenta

Drug: Propofol II
Continued dose of propofol 0.06 mg/kg/min
Other Name: Propofol




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Carl-Johan Jakobsen, Consultant Anesthesiologist, Ass professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02756598    
Other Study ID Numbers: SATA-1
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carl-Johan Jakobsen, Aarhus University Hospital:
sufentanil
propofol
personality/stress test
fast-track
Additional relevant MeSH terms:
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Sufentanil
Dsuvia
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia