Stress, Anxiety and Type A Personality and Analgesics

Overview

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 Title of Study: “Stress, Anxiety and Type A Personality and Analgesics. Impact on Induction Time and Consumption of Analgesics During Cardiac Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 1, 2018

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

  • Drug: Sufentanil I
    • bolus dose of sufentanil 1 microgram/kg
  • Drug: Sufentanil II
    • bolus dose of sufentanil 0.5 microgram/kg
  • Drug: Propofol I
    • Continued dose of propofol 0.03 mg/kg/min
  • Drug: Propofol II
    • Continued dose of propofol 0.06 mg/kg/min

Arms, Groups and Cohorts

  • Active Comparator: Sufentanil I
    • Randomized arm “moderate” sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min
  • Active Comparator: Sufentanil II
    • Randomized arm “low” sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aarhus University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carl-Johan Jakobsen, Consultant Anesthesiologist, Ass professor – Aarhus University Hospital

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