Heart Valve DiseasesNCT01524354
Depth of Anesthesia in Cardiac Surgery
A study testing maintenance of anesthesia in people with Heart Valve Diseases, run by Northern State Medical University.
Trial summary
The aim of our study was to evaluate the significance of monitoring anesthetic depth for the conduct of anesthesia and the early postoperative period in patients subjected to surgical correction of combined valvular disorders. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- maintenance of anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Dec 2011
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- requirement of surgical correction of two or more valves
Who cannot join
- no
About this study
Official title: Monitoring of Anesthetic Depth During Surgical Correction of Acquired Valvular Disorders
The aim of our study was to evaluate the significance of monitoring anesthetic depth for the conduct of anesthesia and the early postoperative period in patients subjected to surgical correction of combined valvular disorders.
Read the detailed description
Our aim was to evaluate the effect of monitoring anesthetic depth on duration of postoperative mechanical ventilation and ICU stay after surgical correction of combined valvular disorders.
- Conditions
- Heart Valve Diseases
- Being tested
- maintenance of anesthesia
- Keywords
- depth of anesthesia, valve surgery
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintenance of anesthesiaProcedure or surgery
Also called Controlled anesthesia depth
intraoperative maintenance of anesthesia with propofol under control of cerebral state index at 40-60 points
maintenance of anesthesiaProcedure or surgery
Also called Controlled anesthesia depth
intraoperative maintenance of anesthesia with propofol according to recommendations of the manufacturer
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients received maintenance of anesthesia with continuous infusion of propofol according to recommendations of the manufacturer. Receives: Procedure: maintenance of anesthesia |
| cerebral state index | Active comparator | Patients received continuous infusion of propofol with rate maintaining cerebral state index (CSI) between 40 and 60 points. Receives: Procedure: maintenance of anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of postoperative mechanical ventilation
Criteria for termination of postoperative respiratory support were the following: patient able to cooperate; adequate muscular tone; SpO2 > 95% with FiO2 0.5; PaCO2 < 45 mm Hg; postoperative bleeding rate < 50 mL hr-1; stable hemodynamics without inotropic/vasopressor support; body temperature of > 35 °C. Temporary pacing was not regarded as a contraindication for tracheal extubation.
Measured: 24 hours postoperatively
Secondary outcomes (1)
length of ICU stay
The time until 'fit for ICU discharge' criteria as well as the actual length of the ICU stay were registered. The 'fit for ICU discharge' criteria included the following: fully oriented patient, SaO2 > 90% on room air, no episodes of severe arrhythmias, bleeding < 50 mL hr-1, diuresis > 0.5 mL kg-1 hr-1, no need for inotropic/vasopressor support and no signs of ischemia on ECG.
Measured: 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikhail Y Kirov, MD, PhD, Study director, Northern State Medical Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524354
- Sponsor's protocol ID
- Depth-28
- Status last verified
- Sep 2012
- First submitted
- 30 Jan 2012
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Anesthetic Depth During Surgical Correction of Acquired Valvular Disorders
- ClinicalTrials.gov ID
- NCT01524354
- Acronym / sponsor ID
- Depth-28
- Conditions
- Heart Valve Diseases
- Keywords
- depth of anesthesia, valve surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Feb 2012 (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.
The aim of our study was to evaluate the significance of monitoring anesthetic depth for the conduct of anesthesia and the early postoperative period in patients subjected to surgical correction of combined valvular disorders.
Detailed description
Our aim was to evaluate the effect of monitoring anesthetic depth on duration of postoperative mechanical ventilation and ICU stay after surgical correction of combined valvular disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: maintenance of anesthesiaPatients received maintenance of anesthesia with continuous infusion of propofol according to recommendations of the manufacturer. |
| cerebral state index | Active comparator | Procedure: maintenance of anesthesiaPatients received continuous infusion of propofol with rate maintaining cerebral state index (CSI) between 40 and 60 points. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- requirement of surgical correction of two or more valves
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| maintenance of anesthesiaAlso: Controlled anesthesia depthintraoperative maintenance of anesthesia with propofol under control of cerebral state index at 40-60 points | Procedure or surgery | cerebral state index |
| maintenance of anesthesiaAlso: Controlled anesthesia depthintraoperative maintenance of anesthesia with propofol according to recommendations of the manufacturer | Procedure or surgery | Control |
Primary outcome
duration of postoperative mechanical ventilation
Time frame: 24 hours postoperatively
Criteria for termination of postoperative respiratory support were the following: patient able to cooperate; adequate muscular tone; SpO2 > 95% with FiO2 0.5; PaCO2 < 45 mm Hg; postoperative bleeding rate < 50 mL hr-1; stable hemodynamics without inotropic/vasopressor support; body temperature of > 35 °C. Temporary pacing was not regarded as a contraindication for tracheal extubation.
1 secondary outcome
length of ICU stay
Time frame: 7 days postoperatively
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 12 Sep 2012.
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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.
Mikhail Y Kirov, MD, PhD study director
Northern State Medical Univercity
Questions about this trial
What is this clinical trial studying?
A study testing maintenance of anesthesia in people with Heart Valve Diseases, run by Northern State Medical University.
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 1 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 12 Sep 2012. 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.
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?
duration of postoperative mechanical ventilation (time frame: 24 hours postoperatively). 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 12 Sep 2012.