Stress, Anxiety and Type A Personality and Analgesics

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative; Dysfunction Following Cardiac Surgery

Intervention / Treatment
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* Drug: Sufentanil I
* Drug: Sufentanil II
* Drug: Propofol I
* Drug: Propofol II


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 90 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sufentanil I<br>Randomized arm moderate sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min | Drug: Sufentanil I<br>* bolus dose of sufentanil 1 microgram/kg<br>* Other names: Sufenta;Drug: Propofol I<br>* Continued dose of propofol 0.03 mg/kg/min<br>* Other names: Propofol;|
| Active Comparator: Sufentanil II<br>Randomized arm low sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min | Drug: Sufentanil II<br>* bolus dose of sufentanil 0.5 microgram/kg<br>* Other names: Sufenta;Drug: Propofol II<br>* Continued dose of propofol 0.06 mg/kg/min<br>* Other names: Propofol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between preoperative personality/stress/anxiety and time (minutes) to reach anaesthetic depth goal by bi-spectral index (BIS) | Minutes to reach BIS 50 | Up to 30 minutes | 
| Potential of sufentanil regime on fast-track measured by ventilation time and association with eligible discharge from intensive care unit. | Postoperative ventilation time (hours/minutes) and the association to eligible discharge from ICU. | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sufentanil regime and association to haemodynamic parameters (blood pressures, heart rate, cardiac output, oxygenation) | Perioperative changes in haemodynamic parameters (analysis of varians) of haemodynamic parameters according to sufentanil regime | up to 24 hours | 
| Association between preoperative personality/stress/anxiety tests and postoperative care using postoperative quality score | Association of preoperative tests and the postoperative ICU quality scoring | up to 24 hours | 
| Association between preoperative personality/stress/anxiety and total amounts of sufentanil and propofol | Amounts of drugs as pr kg pr time unit of involved drugs | Up to 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sufentanil, propofol, personality/stress test, fast-track