AnesthesiaPhase 4NCT03417518
Effects of Anesthesia With Propofol Versus Desflurane in Obese Patients
A Phase 4 study testing Desflurane Inhalant Product and Propofol in people with Anesthesia and Obesity, run by Centre Hospitalier Universitaire Saint Pierre.
Trial summary
Evaluate the effects of propofol compared with desflurane on oxidative stress and inflammation markers in obese patients undergoing scheduled bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Obesity
- What is being tested?
- Desflurane Inhalant Product and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) >35
- scheduled gastric by pass surgery
- American Society of Anesthesiologists (ASA) <III
Who cannot join
- Allergic to anesthesia agent
- patient refusal
About this study
Official title: Effects of General Anesthesia With Propofol Versus Desflurane on Oxidative Stress and Inflammation in Obese Patients Scheduled for Bariatric Surgery
Evaluate the effects of propofol compared with desflurane on oxidative stress and inflammation markers in obese patients undergoing scheduled bariatric surgery.
Read the detailed description
Obese patients have a high level of oxidative stress and inflammation activity. Desflurane is an anesthetic gas often used for obese patients. Propofol, another anesthetic agent, has shown an antioxidant property. The aim of the study is to compare the effects of propofol with desflurane on oxidative stress and inflammation markers in obese patients.
- Conditions
- Anesthesia, Obesity
- Being tested
- Desflurane Inhalant Product, Propofol
- Keywords
- Oxidative stress, Bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desflurane Inhalant ProductDrug
Also called Suprane
General anesthesia will be induced with sufentanyl (0.2µg/kg) and thiopental (5mg/kg) and maintained by desflurane
PropofolDrug
Also called Diprivan
General anesthesia will be induced with propofol (2mg/kg) and sufentanyl (0.2µg/kg) and maintained by propofol in a target-controlled infusion mode
| Study group | Role | What they receive |
|---|---|---|
| Desflurane Inhalant Product Group | Active comparator | general anesthesia with desflurane Receives: Drug: Desflurane Inhalant Product |
| Propofol Group | Experimental | general anesthesia with propofol Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malondialdehyde (MDA) level in blood sample
Plasma MDA level is measured as an oxidative stress marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.
Measured: up to 24 hours post bariatric surgery
Secondary outcomes (4)
C-Reactive Protein (CRP) in blood sample
Plasma CRP level is measured as an inflammation marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.
Measured: up to 24 hours post bariatric surgery
Monocyte level in blood sample
Monocyte level is measured as an inflammation marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.
Measured: up to 24 hours post bariatric surgery
Pain assessed by Visual Analog Scale (VAS)
Pain level is determined at 2 hours, 24 hours and 48 hours post-surgical incision. Visual analog pain score (scale = 0 no pain; 10= worst pain imaginable)
Measured: up to 48 hours after surgery
Side-effects (nausea, vomiting, somnolence, respiratory depression)
Evaluation at 2 hours, 24 hours and 48 hours post-surgical incision
Measured: up to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study startJan 2015
- Primary completionOct 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panayota Kapessidou, Study director, University Hospital Saint-Pierre (CHU Saint-Pierre), Universite libre de Bruxelles (ULB)Livia Di Marco, doctor, Principal investigator, University Hospital Saint-Pierre (CHU Saint-Pierre)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417518
- Sponsor's protocol ID
- B076201420067
- Status last verified
- Feb 2018
- First submitted
- 25 Jan 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skalicky J, Muzakova V, Kandar R, Meloun M, Rousar T, Palicka V. Evaluation of oxidative stress and inflammation in obese adults with metabolic syndrome. Clin Chem Lab Med. 2008;46(4):499-505. doi: 10.1515/CCLM.2008.096.
PubMed 18298345Del Rio D, Stewart AJ, Pellegrini N. A review of recent studies on malondialdehyde as toxic molecule and biological marker of oxidative stress. Nutr Metab Cardiovasc Dis. 2005 Aug;15(4):316-28. doi: 10.1016/j.numecd.2005.05.003.
PubMed 16054557Murphy PG, Myers DS, Davies MJ, Webster NR, Jones JG. The antioxidant potential of propofol (2,6-diisopropylphenol). Br J Anaesth. 1992 Jun;68(6):613-8. doi: 10.1093/bja/68.6.613.
PubMed 1319189
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of General Anesthesia With Propofol Versus Desflurane on Oxidative Stress and Inflammation in Obese Patients Scheduled for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03417518
- Acronym / sponsor ID
- B076201420067
- Conditions
- Anesthesia, Obesity
- Keywords
- Oxidative stress, Bariatric surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Jan 2018 (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.
Evaluate the effects of propofol compared with desflurane on oxidative stress and inflammation markers in obese patients undergoing scheduled bariatric surgery.
Detailed description
Obese patients have a high level of oxidative stress and inflammation activity. Desflurane is an anesthetic gas often used for obese patients. Propofol, another anesthetic agent, has shown an antioxidant property. The aim of the study is to compare the effects of propofol with desflurane on oxidative stress and inflammation markers in obese patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane Inhalant Product Group | Active comparator | Drug: Desflurane Inhalant Productgeneral anesthesia with desflurane |
| Propofol Group | Experimental | Drug: Propofolgeneral anesthesia with propofol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) >35
- scheduled gastric by pass surgery
- American Society of Anesthesiologists (ASA) <III
Key exclusion criteria (2 listed)
- Allergic to anesthesia agent
- patient refusal
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 |
|---|---|---|
| Desflurane Inhalant ProductAlso: SupraneGeneral anesthesia will be induced with sufentanyl (0.2µg/kg) and thiopental (5mg/kg) and maintained by desflurane | Drug | Desflurane Inhalant Product Group |
| PropofolAlso: DiprivanGeneral anesthesia will be induced with propofol (2mg/kg) and sufentanyl (0.2µg/kg) and maintained by propofol in a target-controlled infusion mode | Drug | Propofol Group |
Primary outcome
Malondialdehyde (MDA) level in blood sample
Time frame: up to 24 hours post bariatric surgery
Plasma MDA level is measured as an oxidative stress marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.
4 secondary outcomes
C-Reactive Protein (CRP) in blood sample
Time frame: up to 24 hours post bariatric surgery
Monocyte level in blood sample
Time frame: up to 24 hours post bariatric surgery
Pain assessed by Visual Analog Scale (VAS)
Time frame: up to 48 hours after surgery
Side-effects (nausea, vomiting, somnolence, respiratory depression)
Time frame: up to 48 hours after surgery
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 9 Feb 2018.
- Background: PubMed 18298345Skalicky J, Muzakova V, Kandar R, Meloun M, Rousar T, Palicka V. Evaluation of oxidative stress and inflammation in obese adults with metabolic syndrome. Clin Chem Lab Med. 2008;46(4):499-505. doi: 10.1515/CCLM.2008.096.
- Background: PubMed 16054557Del Rio D, Stewart AJ, Pellegrini N. A review of recent studies on malondialdehyde as toxic molecule and biological marker of oxidative stress. Nutr Metab Cardiovasc Dis. 2005 Aug;15(4):316-28. doi: 10.1016/j.numecd.2005.05.003.
- Background: PubMed 1319189Murphy PG, Myers DS, Davies MJ, Webster NR, Jones JG. The antioxidant potential of propofol (2,6-diisopropylphenol). Br J Anaesth. 1992 Jun;68(6):613-8. doi: 10.1093/bja/68.6.613.
- Individual participant dataSharing planned: No
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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.
Panayota Kapessidou study director
University Hospital Saint-Pierre (CHU Saint-Pierre), Universite libre de Bruxelles (ULB)
Livia Di Marco, doctor principal investigator
University Hospital Saint-Pierre (CHU Saint-Pierre)
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desflurane Inhalant Product and Propofol in people with Anesthesia and Obesity, run by Centre Hospitalier Universitaire Saint Pierre.
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 3 inclusion and 2 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 9 Feb 2018. 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.
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?
Malondialdehyde (MDA) level in blood sample (time frame: up to 24 hours post bariatric surgery). 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 NCT03417518, which also lists 3 linked publications.
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 9 Feb 2018.