AnesthesiaPhase 4NICOM-MAPNCT01594021
Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia
A Phase 4 study testing Gelatin 500 mL and Gelatin 50 mL in people with Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Gelatin 500 mL and Gelatin 50 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Jun 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing elective surgery.
Who cannot join
- Difficult peripheral venous access
- Allergy to gelatin
- Symptomatic cardiac disease, rhythm trouble, pace-maker, aortic valvular disease, aortic disease
- Morbid obesity, low BMI,
- hypovolemia,
- Raynaud syndrome or scleroderma,
- Contra-indication to propofol, remifentanil or to the use of Bispectral Index,
- Hematocrit < 20%.
Trial locations and contacts
1 site in 1 country.
About this study
Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.
Read the detailed description
This is a randomized, prospective study which will include a total of 200 patients who are scheduled to undergo elective surgery. The research participants will be randomly assigned to
- a control group that will receive a low preemptive volume loading (50 mL of gelatin),
- a protocol group that will receive a high preemptive volume loading (500 mL of gelatin).
Volume loading is preceded by the measurement of stroke volume and cardiac output before and after a passive leg elevation test and followed by a standardized anesthetic protocol.
- Conditions
- Anesthesia
- Being tested
- Gelatin 500 mL, Gelatin 50 mL
- Keywords
- propofol, anesthesia, induction, hypotension, cardiac output
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelatin 500 mLDrug
intravenous administration
Gelatin 50 mLDrug
intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| High pre-emptive volume loading | Experimental | Not described Receives: Drug: Gelatin 500 mL |
| Low pre-emptive volume loading | Active comparator | Not described Receives: Drug: Gelatin 50 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
mean arterial pressure less than 70% of the baseline measurement
Measured: 30 minutes
Secondary outcomes (6)
hemodynamic effect of leg passive elevation test
Measured: 30 minutes
hemodynamic effect of volume loading
Measured: 30 minutes
heart rate monitoring
Measured: 30 minutes
propofol dose when bispectral index is 50
Measured: 30 minutes
propofol site effect concentration when bispectral index is 50
Measured: 30 minutes
arterial pressure monitoring
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Difficulty of realization of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Le Guen, Principal investigator, Hopital FochMarc Fischler, Study director, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594021
- Sponsor's protocol ID
- 2012/13
- Other IDs
- 2012-A00368-35
- Acronym
- NICOM-MAP
- Status last verified
- Oct 2016
- First submitted
- 5 May 2012
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia
- ClinicalTrials.gov ID
- NCT01594021
- Acronym / sponsor ID
- NICOM-MAP / 2012/13
- Conditions
- Anesthesia
- Keywords
- propofol, anesthesia, induction, hypotension, cardiac output
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty of realization of the study
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 May 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.
Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.
Detailed description
This is a randomized, prospective study which will include a total of 200 patients who are scheduled to undergo elective surgery. The research participants will be randomly assigned to
- a control group that will receive a low preemptive volume loading (50 mL of gelatin),
- a protocol group that will receive a high preemptive volume loading (500 mL of gelatin).
Volume loading is preceded by the measurement of stroke volume and cardiac output before and after a passive leg elevation test and followed by a standardized anesthetic protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High pre-emptive volume loading | Experimental | Drug: Gelatin 500 mL |
| Low pre-emptive volume loading | Active comparator | Drug: Gelatin 50 mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing elective surgery.
Key exclusion criteria (8 listed)
- Difficult peripheral venous access
- Allergy to gelatin
- Symptomatic cardiac disease, rhythm trouble, pace-maker, aortic valvular disease, aortic disease
- Morbid obesity, low BMI,
- hypovolemia,
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 |
|---|---|---|
| Gelatin 500 mLintravenous administration | Drug | High pre-emptive volume loading |
| Gelatin 50 mLintravenous administration | Drug | Low pre-emptive volume loading |
Primary outcome
Hypotension
Time frame: 30 minutes
mean arterial pressure less than 70% of the baseline measurement
6 secondary outcomes
hemodynamic effect of leg passive elevation test
Time frame: 30 minutes
hemodynamic effect of volume loading
Time frame: 30 minutes
heart rate monitoring
Time frame: 30 minutes
propofol dose when bispectral index is 50
Time frame: 30 minutes
propofol site effect concentration when bispectral index is 50
Time frame: 30 minutes
arterial pressure monitoring
Time frame: 30 minutes
Results and safety
The study was stopped early (reason given: Difficulty of realization of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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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.
Morgan Le Guen principal investigator
Hopital Foch
Marc Fischler study director
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gelatin 500 mL and Gelatin 50 mL in people with Anesthesia, run by Hopital Foch at 1 site in France.
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 8 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: stopped early, as of the sponsor's last update on 31 Oct 2016. 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 France. 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 was stopped early (reason given: Difficulty of realization of the 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?
Hypotension (time frame: 30 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 31 Oct 2016.