Morbid ObesityPhase 3NCT01724983
Ketamine in Bariatric Surgery
A Phase 3 study testing ketamine and fentanyl in people with Morbid Obesity, run by University of Padova at 1 site in Italy.
Trial summary
Ketamine may improve recovery from bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- ketamine and fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2012to Jun 2014
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18
- obesity (Body Mass Index > 30)
- ASA classificazion < 4
- candidate to bariatric surgery
Who cannot join
- known or presumed pregnancy
- previous surgery on the airway, esophagus or stomach
- uncontrolled psychiatric symptomatology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ketamine on Recovery From Bariatric Surgery
Ketamine may improve recovery from bariatric surgery.
- Conditions
- Morbid Obesity
- Keywords
- pain, mood, depression, respiration
- Medical subject headings
- Obesity, Morbid, Pain, Depression, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ketamine | Experimental | patients will receive ketamine at induction Receives: Drug: ketamine |
| fentanyl | Active comparator | patients will receive fentanyl at induction Receives: Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level
Measured: postoperatively, up to 3 months
mood level
Measured: postoperatively, up to 3 months
Secondary outcomes (7)
total dosages of analgesic and muscle relaxant drugs
Measured: postoperatively, up to 3 months
postanesthetic recovery
Measured: postoperatively, up to 24 hours
satisfaction of the patient and of the surgeon
Measured: day 1
pulse oximetry saturation
Measured: postoperatively, up to 24 hours
lung volumes
Measured: postoperatively, up to 48 hours from end of surgery
antihemetic drug dosage
Measured: postoperatively, up to 24 hours
vasoactive drugs
Measured: intraoperatively and up to 24 hours from surgery end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulderico Freo, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724983
- Sponsor's protocol ID
- KET2271
- Status last verified
- Nov 2012
- First submitted
- 14 Sep 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketamine on Recovery From Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01724983
- Acronym / sponsor ID
- KET2271
- Conditions
- Morbid Obesity
- Keywords
- pain, mood, depression, respiration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 12 Nov 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.
Ketamine may improve recovery from bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine | Experimental | Drug: ketaminepatients will receive ketamine at induction |
| fentanyl | Active comparator | Drug: fentanylpatients will receive fentanyl at induction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18
- obesity (Body Mass Index > 30)
- ASA classificazion < 4
- candidate to bariatric surgery
Key exclusion criteria (3 listed)
- known or presumed pregnancy
- previous surgery on the airway, esophagus or stomach
- uncontrolled psychiatric symptomatology
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 |
|---|---|---|
| ketamine | Drug | ketamine |
| fentanyl | Drug | fentanyl |
Primary outcome
pain level
Time frame: postoperatively, up to 3 months
mood level
Time frame: postoperatively, up to 3 months
7 secondary outcomes
total dosages of analgesic and muscle relaxant drugs
Time frame: postoperatively, up to 3 months
postanesthetic recovery
Time frame: postoperatively, up to 24 hours
satisfaction of the patient and of the surgeon
Time frame: day 1
pulse oximetry saturation
Time frame: postoperatively, up to 24 hours
lung volumes
Time frame: postoperatively, up to 48 hours from end of surgery
antihemetic drug dosage
Time frame: postoperatively, up to 24 hours
vasoactive drugs
Time frame: intraoperatively and up to 24 hours from surgery end
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 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.
Ulderico Freo, MD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ketamine and fentanyl in people with Morbid Obesity, run by University of Padova at 1 site in Italy.
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 4 inclusion and 3 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 12 Nov 2012. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
pain level (time frame: postoperatively, up to 3 months). The study lists 2 primary outcomes in all. 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 Nov 2012.