Stress, Anxiety and Type A Personality and Analgesics

NCT ID: NCT02756598

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative; Dysfunction Following Cardiac Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sufentanil I

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

Group Type ACTIVE_COMPARATOR

Sufentanil I

Intervention Type DRUG

bolus dose of sufentanil 1 microgram/kg

Propofol I

Intervention Type DRUG

Continued dose of propofol 0.03 mg/kg/min

Sufentanil II

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

Group Type ACTIVE_COMPARATOR

Sufentanil II

Intervention Type DRUG

bolus dose of sufentanil 0.5 microgram/kg

Propofol II

Intervention Type DRUG

Continued dose of propofol 0.06 mg/kg/min

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sufentanil I

bolus dose of sufentanil 1 microgram/kg

Intervention Type DRUG

Sufentanil II

bolus dose of sufentanil 0.5 microgram/kg

Intervention Type DRUG

Propofol I

Continued dose of propofol 0.03 mg/kg/min

Intervention Type DRUG

Propofol II

Continued dose of propofol 0.06 mg/kg/min

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sufenta Sufenta Propofol Propofol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carl-Johan Jakobsen

Consultant Anesthesiologist, Ass professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SATA-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Audiovisual Aid Pilot Study
NCT02506673 COMPLETED NA