Stress, Anxiety and Type A Personality and Analgesics

NCT02756598 | Completed Phase 4

• 1 other identifier: SATA-1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Postoperative; Dysfunction Following Cardiac Surgery

Keywords

sufentanil; propofol; personality/stress test; fast-track

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Sufentanil regime and association to haemodynamic parameters (blood pressures, heart rate, cardiac output, oxygenation)

  up to 24 hours

• Association between preoperative personality/stress/anxiety tests and postoperative care using postoperative quality score

  up to 24 hours

• Association between preoperative personality/stress/anxiety and total amounts of sufentanil and propofol

  Up to 12 hours

Study Arms (2)

Sufentanil I

ACTIVE COMPARATOR

Randomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min

Drug: Sufentanil I; Drug: Propofol I

Sufentanil II

ACTIVE COMPARATOR

Randomized arm "low" sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min

Drug: Sufentanil II; Drug: Propofol II

Interventions

Sufentanil I DRUG

bolus dose of sufentanil 1 microgram/kg

Also known as: Sufenta

Sufentanil I

Sufentanil II DRUG

bolus dose of sufentanil 0.5 microgram/kg

Also known as: Sufenta

Sufentanil II

Propofol I DRUG

Continued dose of propofol 0.03 mg/kg/min

Also known as: Propofol

Sufentanil I

Propofol II DRUG

Continued dose of propofol 0.06 mg/kg/min

Also known as: Propofol

Sufentanil II

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All elective cardiac surgery patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

MeSH Terms

Interventions

Sufentanil; Propofol

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologist, Ass professor

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: April 29, 2016
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: June 30, 2018
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share