Stress, Anxiety and Type A Personality and Analgesics (SATA-1)

July 9, 2019 updated by: Carl-Johan Jakobsen, Aarhus University Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sufentanil I
Randomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min
Drug: Sufentanil I
bolus dose of sufentanil 1 microgram/kg
Other Names:
  • Sufenta
Drug: Propofol I
Continued dose of propofol 0.03 mg/kg/min
Other Names:
  • Propofol
Active Comparator: Sufentanil II
Randomized arm "low" sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min
Drug: Sufentanil II
bolus dose of sufentanil 0.5 microgram/kg
Other Names:
  • Sufenta
Drug: Propofol II
Continued dose of propofol 0.06 mg/kg/min
Other Names:
  • Propofol

What is the study measuring?

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)
Time Frame: Up to 30 minutes
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.
Time Frame: Up to 24 hours
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)
Time Frame: up to 24 hours
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
Time Frame: up to 24 hours
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
Time Frame: Up to 12 hours
Amounts of drugs as pr kg pr time unit of involved drugs
Up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SATA-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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