Postoperative; Dysfunction Following Cardiac SurgeryPhase 4SATA-1NCT02756598
Stress, Anxiety and Type A Personality and Analgesics
A Phase 4 study testing Sufentanil I, Sufentanil II and Propofol I in people with Postoperative; Dysfunction Following Cardiac Surgery, run by Aarhus University Hospital.
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… Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Postoperative; Dysfunction Following Cardiac Surgery
- What is being tested?
- Sufentanil I, Sufentanil II and Propofol I
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to 30 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All elective cardiac surgery patients
Who cannot join
- 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
About this study
Official title: 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).
Read the 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.
- Being tested
- Sufentanil I, Sufentanil II, Propofol I, Propofol II
- Keywords
- sufentanil, propofol, personality/stress test, fast-track
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil IDrug
Also called Sufenta
bolus dose of sufentanil 1 microgram/kg
Sufentanil IIDrug
Also called Sufenta
bolus dose of sufentanil 0.5 microgram/kg
Propofol IDrug
Also called Propofol
Continued dose of propofol 0.03 mg/kg/min
Propofol IIDrug
Also called Propofol
Continued dose of propofol 0.06 mg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil I | Active comparator | Randomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min Receives: 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 Receives: Drug: Sufentanil II; Drug: Propofol II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between preoperative personality/stress/anxiety and time (minutes) to reach anaesthetic depth goal by bi-spectral index (BIS)
Minutes to reach BIS 50
Measured: 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.
Measured: Up to 24 hours
Secondary outcomes (3)
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
Measured: up to 24 hours
Association between preoperative personality/stress/anxiety tests and postoperative care using postoperative quality score
Association of preoperative tests and the postoperative ICU quality scoring
Measured: up to 24 hours
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
Measured: Up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJan 2015
- Primary completion1 Jan 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative; Dysfunction Following Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl-Johan Jakobsen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756598
- Sponsor's protocol ID
- SATA-1
- Acronym
- SATA-1
- Status last verified
- Jul 2019
- First submitted
- 30 Dec 2015
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress, Anxiety and Type A Personality and Analgesics. Impact on Induction Time and Consumption of Analgesics During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02756598
- Acronym / sponsor ID
- SATA-1 / SATA-1
- Keywords
- sufentanil, propofol, personality/stress test, fast-track
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil I | Active comparator | Drug: Sufentanil I, Drug: Propofol IRandomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min |
| Sufentanil II | Active comparator | Drug: Sufentanil II, Drug: Propofol IIRandomized arm "low" sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min |
Who may qualify
- Ages
- 16 to 90 years
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All elective cardiac surgery patients
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufentanil IAlso: Sufentabolus dose of sufentanil 1 microgram/kg | Drug | Sufentanil I |
| Sufentanil IIAlso: Sufentabolus dose of sufentanil 0.5 microgram/kg | Drug | Sufentanil II |
| Propofol IAlso: PropofolContinued dose of propofol 0.03 mg/kg/min | Drug | Sufentanil I |
| Propofol IIAlso: PropofolContinued dose of propofol 0.06 mg/kg/min | Drug | Sufentanil II |
Primary outcome
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
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.
3 secondary outcomes
Sufentanil regime and association to haemodynamic parameters (blood pressures, heart rate, cardiac output, oxygenation)
Time frame: 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 between preoperative personality/stress/anxiety and total amounts of sufentanil and propofol
Time frame: Up to 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sufentanil I, Sufentanil II and Propofol I in people with Postoperative; Dysfunction Following Cardiac Surgery, run by Aarhus University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.