Stress, Anxiety and Type A Personality and Analgesics

Phase 4

Completed

• Conditions: Postoperative; Dysfunction Following Cardiac Surgery
• Interventions: Drug: Sufentanil I; Drug: Sufentanil II; Drug: Propofol II; Drug: Propofol I

• Registration Number: NCT02756598
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-29
• Primary Completion: 2018-01-01
• Study Completion: 2018-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanil II	Propofol II	Randomized arm "low" sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min
Sufentanil I	Sufentanil I	Randomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min
Sufentanil I	Propofol I	Randomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min
Sufentanil II	Sufentanil II	Randomized arm "low" sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min

Primary Outcome Measures

Name	Time	Method
Association between preoperative personality/stress/anxiety and time (minutes) to reach anaesthetic depth goal by bi-spectral index (BIS)	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.	Up to 24 hours	Postoperative ventilation time (hours/minutes) and the association to eligible discharge from ICU.

Secondary Outcome Measures

Name	Time	Method
Association between preoperative personality/stress/anxiety tests and postoperative care using postoperative quality score	up to 24 hours	Association of preoperative tests and the postoperative ICU quality scoring
Sufentanil regime and association to haemodynamic parameters (blood pressures, heart rate, cardiac output, oxygenation)	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 and total amounts of sufentanil and propofol	Up to 12 hours	Amounts of drugs as pr kg pr time unit of involved drugs