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Completed

NCT Number: NCT02756598

Stress, Anxiety and Type A Personality and Analgesics

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).

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Key information

Conditions

Postoperative; Dysfunction Following Cardiac Surgery

Age range

16 year–90 year

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil I

Drug

bolus dose of sufentanil 1 microgram/kg

Other names: Sufenta

Sufentanil II

Drug

bolus dose of sufentanil 0.5 microgram/kg

Other names: Sufenta

Propofol I

Drug

Continued dose of propofol 0.03 mg/kg/min

Other names: Propofol

Propofol II

Drug

Continued dose of propofol 0.06 mg/kg/min

Other names: Propofol

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

Stress, Anxiety and Type A Personality and Analgesics. Impact on Induction Time and Consumption of Analgesics During Cardiac Surgery

Acronym: SATA-1

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2016
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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