Use of perioperative analgetics in cardiac surgerycorrelated to preoperative level of anxiety and stress.

SATA 1 – Stress, Anxiety and Type A personality and analgetics (qualityinsurance project). Level of analgetics in anaesthesia for cardiac surgery evaluated by BIS and EEG monitoring, haemodynamic effect and quality of recovery and correlated to preoperative anxiety and stress tests - SATA1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000017-21-DK

Enrollment

120

Registered

2013-08-26

Start date

2013-10-11

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia and recovery in cardiac surgery patients. MedDRA version: 14.1 Level: LLT Classification code 10021722 Term: Induction and maintenance anaesthesia System Organ Class: 100000004865

Interventions

Trade Name: Sufenta Product Name: Sufentanil Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: SUFENTANIL CAS Number: 56030-54-7 Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients for cardiac surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Patients requiring special anaesthesia or critical preoperative state Patients expected to have long ventilation time and long time in ICU

Design outcomes

Primary

Measure	Time frame
Main Objective: Stress, anxiety and type A personality and analgesic requirements. Level of anaesthesia using BIS and EEG monitoring, haemodynamic effexts and quality of recovery ;Secondary Objective: not applicable;Primary end point(s): Equivalent doses of analgesics to obtain anaesthetic level Effect on ICU score End points correlated to preoperative stress and anxiety tests;Timepoint(s) of evaluation of this end point: End of recovery	—

Measure

Time frame

Main Objective: Stress, anxiety and type A personality and analgesic requirements. Level of anaesthesia using BIS and EEG monitoring, haemodynamic effexts and quality of recovery ;Secondary Objective: not applicable;Primary end point(s): Equivalent doses of analgesics to obtain anaesthetic level Effect on ICU score End points correlated to preoperative stress and anxiety tests;Timepoint(s) of evaluation of this end point: End of recovery

—

Secondary

Measure	Time frame
Secondary end point(s): Difference in ventilation time Difference in quality of recovery Haemodynamic effect of drugs;Timepoint(s) of evaluation of this end point: End of recovery	—

Countries

Denmark

Contacts

Public ContactI-Research

Aarhus University Hospital

lindarsm@rm.dk4578451197

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026