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Disorder; Mental, SedativePhase 4NCT02393066

Comparison of Hemodynamics Between Dexmedetomidine and Propofol for Sedation in Patients With Abdominal Surgery

A Phase 4 study testing Propofol and Dexmedetomidine in people with Disorder; Mental, Sedative and Pain, Postoperative, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor surgery were recruited to participate in the study. Apart from routine treatment in the surgical intensive care unit, the subjects were randomly divided into two groups: Propofol group (Group P) and Dexmedetomidine group (Group D)… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Propofol and Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
Oct 2014to Aug 2015
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • non-emergent major abdominal tumor surgery with ICU admission
  • the need of sedation during ICU stay

Who cannot join

  • age older than 99 years
  • age younger than 20 years
  • refractory arrhythmias
  • refractory shock status after resuscitation
  • new onset of myocardial infarction
  • severe heart failure or NYHA 4
Show all 11Show fewer
  • APACHE score > 30 when recruiting
  • severe liver cirrhosis or CHILD B or C
  • organ transplantation within one year
  • pregnancy
  • allergic to propofol or dexmedetomidine

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, Taipei, 100

Other trials in Taiwan

About this study

Official title: A Comparison of Hemodynamic Effects Between Dexmedetomidine and Propofol for Sedation in Patients With Major Abdominal Tumor Surgery

This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor surgery were recruited to participate in the study. Apart from routine treatment in the surgical intensive care unit, the subjects were randomly divided into two groups: Propofol group (Group P) and Dexmedetomidine group (Group D) and received continuous intravenous infusion of Propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h) or Dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h) according to their assigned group. Patients' hemodynamic status was monitored using a chest Bioreactance technique, Continuous Non-Invasive Cardiac Output and Hemodynamic Monitor at preset time points (time of recruitment [0h], 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results, fluid volume and drugs used were also recorded.

Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02393066
Study groupRoleWhat they receive
propofolActive comparatorthese patients are sedated with propofol infusion during ICU admission
Receives: Drug: Propofol
dexmedetomidineActive comparatorthese patients are sedated with dexmedetomidine infusion during ICU admission
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cardiac index

    the cardiac index measured by the Bioreactance-based noninvasive CO measurement (NICOM system) six hours after recruitment

    Measured: six hours after recruitment

Secondary outcomes (4)

  1. mean arterial pressure

    Measured: six hours after recruitment

  2. heart rate

    Measured: six hours after recruitment

  3. stroke volume

    Measured: six hours after recruitment

  4. urine output

    Measured: six hours after recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionJul 2015
  4. Study completionAug 2015

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02393066
Sponsor's protocol ID
201407023MINA
Status last verified
Aug 2015
First submitted
27 Oct 2014
Last updated
5 Aug 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Propofol and Dexmedetomidine in people with Disorder; Mental, Sedative and Pain, Postoperative, run by National Taiwan University Hospital at 1 site in Taiwan.

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 2 inclusion and 11 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 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

cardiac index (time frame: six hours after recruitment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02393066.

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 5 Aug 2015.

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