Anesthesia, IntravenousNCT04266535
TCI vs Manually Controlled Infusion of Propofol
An observational study of Anesthesia, Intravenous and Laparotomy, run by Regional Hospital West Jutland.
Trial summary
Anesthesia records for patients anesthetized with target controlled infusion of propofol and remifentanil will be matched with patients anesthezied with manyally controlled infusion. The aim of the study is to verify differences in time to extubation and amount of drugs used. anesthetize Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Intravenous, Laparotomy, Airway Extubation
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 Oct 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Anestectic records
Who may be able to join
- Patients to laparoscopic surgery
Who cannot join
- -
About this study
Official title: TCI vs Manually Controlled Infusion of Propofol in Patients Sceduled for Laparoscopic Surgery; a Case-control Study
Anesthesia records for patients anesthetized with target controlled infusion of propofol and remifentanil will be matched with patients anesthezied with manyally controlled infusion.
The aim of the study is to verify differences in time to extubation and amount of drugs used.
anesthetize
- Conditions
- Anesthesia, Intravenous, Laparotomy, Airway Extubation
- Being tested
- Target controlled infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target controlled infusionDevice
Target controlled infusion vs manually controlled infusion
| Study group | Role | What they receive |
|---|---|---|
| TCI | Patients receiving Target Controlled Infusion (TCI) Anesthesia Receives: Device: Target controlled infusion | |
| MCI | Patients receiving Manually Controlled Infusion (MCI) Anesthesia Receives: Device: Target controlled infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post procedural awakening
Time from the surgical procedure has ended until arrival at the post anesthesia unit (PACU)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 May 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, IntravenousStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Regional Hospital West Jutland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niels Peter Ekeløf, Regional Hospital West Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266535
- Sponsor's protocol ID
- TCI/RHWJ
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCI vs Manually Controlled Infusion of Propofol in Patients Sceduled for Laparoscopic Surgery; a Case-control Study
- ClinicalTrials.gov ID
- NCT04266535
- Acronym / sponsor ID
- TCI/RHWJ
- Conditions
- Anesthesia, Intravenous, Laparotomy, Airway Extubation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Regional Hospital West JutlandUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 12 Feb 2020 (actual)
- 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.
Anesthesia records for patients anesthetized with target controlled infusion of propofol and remifentanil will be matched with patients anesthezied with manyally controlled infusion.
The aim of the study is to verify differences in time to extubation and amount of drugs used.
anesthetize
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCI | – | Device: Target controlled infusionPatients receiving Target Controlled Infusion (TCI) Anesthesia |
| MCI | – | Device: Target controlled infusionPatients receiving Manually Controlled Infusion (MCI) Anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Anestectic records
Key inclusion criteria (1 listed)
- Patients to laparoscopic surgery
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Target controlled infusionTarget controlled infusion vs manually controlled infusion | Device | MCI, TCI |
Primary outcome
Post procedural awakening
Time frame: 10 minutes
Time from the surgical procedure has ended until arrival at the post anesthesia unit (PACU)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Anesthesia, Intravenous and Laparotomy, run by Regional Hospital West Jutland.
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: status not confirmed, as of the sponsor's last update on 17 Feb 2020. 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?
Results are not available in the source record.
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?
Post procedural awakening (time frame: 10 minutes). 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 17 Feb 2020.