Stress, Anxiety and Type A Personality and Analgesics

Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial

— SATA-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756598
• Other study ID #: SATA-1
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2019
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative; Dysfunction Following Cardiac Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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