Ambulatory SurgeryPhase 4Propo-FaimNCT02272166
Effects of Propofol on Early Recovery of Hunger After Surgery
A Phase 4 study testing propofol and Sevoflurane in people with Ambulatory Surgery and Anesthesia, run by University Hospital, Rouen at 1 site in France.
Trial summary
Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover, this aspect of post-operative period is often required for discharging patients from hospital after ambulatory surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ambulatory Surgery, Anesthesia, Energy Expenditure
- What is being tested?
- propofol and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Jul 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years old women
- American Society of Anesthesiologists (ASA) score 1-2
- Affiliated to a social security system
- Undergoing an ambulatory surgery during more than 15 minutes with general anesthesia and control of upper airways (tracheal intubation or supraglottic mask or facial mask ventilation) for oocytes punction before in vitro fertilization
- General anesthesia occuring between 8 and 10 am with respect of pre-operative fasting rules
- APFEL risk score for nausea and vomiting ≤ 2/4
- Ability to understand and read french
- Signature of understood consent
Who cannot join
- Other surgery than oocytes punction
- Cognitive dysfunction
- Undernutrition or risk factor of undernutrition (evolutive neoplasia, chronic alcoholism …)
- BMI ≥ 35 kg/m²
- Eating disorders
- Diabetes mellitus
Show all 15Show fewer
- Chronic treatment with drugs modifying feeding behavior :
- Benzodiazepines
- Inhibitors of serotonin reuptake
- Others
- Non respect of pre-operative fasting rules
- Indication for rapid sequence induction (gastro-oesophageal reflux, absence of gastric emptying …)
- Contraindication to propofol (allergia to propofol, soybean or peanuts, past history of propofol infusion syndrome, unstable cardiovascular disease) or to sevoflurane (past history of malignant hyperthermia, epilepsy or liver disorders after administration of a halogenated anesthetic)
- Pregnant or breastfeeding woman
- Involvement in another clinical trial under 4 previous weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Propofol on Early Recovery of Hunger After Ambulatory Surgery Compared With Sevoflurane
Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover, this aspect of post-operative period is often required for discharging patients from hospital after ambulatory surgery. Indeed, this item is part of a multi-parameter score (Chung score) whose validation evaluates patient's ability to return home.
The impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic effect of propofol compared to halogenated gases. These studies had neither the power nor the methodology to answer the question. The aim of our study is to evaluate the impact of propofol versus sevoflurane on early recovery of hunger after ambulatory surgery.
- Conditions
- Ambulatory Surgery, Anesthesia, Energy Expenditure, Food Intake
- Being tested
- propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called diprivan, 2,6-bis(propan-2-yl)phénol
SevofluraneDrug
Also called Sevorane, 1,1,1,3,3,3-hexafluoro-2-(fluorométhoxy)propane
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | Hypnotic used in this arm is exclusively intra-venous propofol. Receives: Drug: propofol |
| sevoflurane | Active comparator | Hypnotic used in this arm is exclusively inhaled sevoflurane. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time before recovery of hunger after general anesthesia
Time before appearance of of hunger (evaluated by a score above 50/100 mm on analogic visual scale) after the end of hypnotic administration (propofol or sevoflurane).
Measured: 1-4 hours
Secondary outcomes (6)
Feeding comfort
Amount of food intake evaluated by a specific scale
Measured: 1-4 hours
Post operative nausea and vomiting
Measured: 1-4 hours
Validation of Chung score
Time needed to obtain a Chung score superior or equal to 9/10, permitting the patient to return home
Measured: 1-4 hours
Change in plasmatic leptin level
Change in plasmatic leptin level (expressed in ng/ml) at the end of anesthesia, one and two hours later, compared with pre-operative value for each patient. Dosage is realized by ELISA method.
Measured: 0-3 hours
Change in plasmatic insulin level
Change in plasmatic insulin level (expressed in microU/ml) at the end of anesthesia, one and two hours later, compared with pre-operative value for each patient. Dosage is realized by ELISA method.
Measured: 0-3 hours
Change in plasmatic ghrelin level
Change in plasmatic ghrelin level (expressed in pg/ml) at the end of anesthesia, one and two hours later, compared with pre-operative value for each patient. Dosage is realized by ELISA method.
Measured: 0-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ambulatory SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Henri Becquerel
- Responsible party
- Sponsor
- Investigators
- Bertrand Dureuil, MD-PHD, Study chair, Departement of Anesthesia, University Hospital, RouenEmmanuel BESNIER, MD, Principal investigator, Departement of Anesthesia, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272166
- Sponsor's protocol ID
- 2014/088/HP
- Acronym
- Propo-Faim
- Status last verified
- Dec 2017
- First submitted
- 15 Oct 2014
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Besnier E, Perdrix A, Gillibert A, Selim J, Froemer B, Ghemired A, Berby B, Rives N, Dureuil B, Clavier T, Compere V. Postoperative hunger after outpatient surgery in patients anesthetized with propofol vs sevoflurane: a randomized-controlled trial. Can J Anaesth. 2020 May;67(5):550-559. doi: 10.1007/s12630-020-01584-w. Epub 2020 Jan 29.
PubMed 31997087
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Propofol on Early Recovery of Hunger After Ambulatory Surgery Compared With Sevoflurane
- ClinicalTrials.gov ID
- NCT02272166
- Acronym / sponsor ID
- Propo-Faim / 2014/088/HP
- Conditions
- Ambulatory Surgery, Anesthesia, Energy Expenditure, Food Intake
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Centre Henri Becquerel
- Study start
- Nov 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Oct 2014 (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.
Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover, this aspect of post-operative period is often required for discharging patients from hospital after ambulatory surgery. Indeed, this item is part of a multi-parameter score (Chung score) whose validation evaluates patient's ability to return home.
The impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic effect of propofol compared to halogenated gases. These studies had neither the power nor the methodology to answer the question. The aim of our study is to evaluate the impact of propofol versus sevoflurane on early recovery of hunger after ambulatory surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: propofolHypnotic used in this arm is exclusively intra-venous propofol. |
| sevoflurane | Active comparator | Drug: SevofluraneHypnotic used in this arm is exclusively inhaled sevoflurane. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-45 years old women
- American Society of Anesthesiologists (ASA) score 1-2
- Affiliated to a social security system
- Undergoing an ambulatory surgery during more than 15 minutes with general anesthesia and control of upper airways (tracheal intubation or supraglottic mask or facial mask ventilation) for oocytes punction before in vitro fertilization
- General anesthesia occuring between 8 and 10 am with respect of pre-operative fasting rules
Key exclusion criteria (15 listed)
- Other surgery than oocytes punction
- Cognitive dysfunction
- Undernutrition or risk factor of undernutrition (evolutive neoplasia, chronic alcoholism …)
- BMI ≥ 35 kg/m²
- Eating disorders
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 |
|---|---|---|
| propofolAlso: diprivan, 2,6-bis(propan-2-yl)phénol | Drug | propofol |
| SevofluraneAlso: Sevorane, 1,1,1,3,3,3-hexafluoro-2-(fluorométhoxy)propane | Drug | sevoflurane |
Primary outcome
Time before recovery of hunger after general anesthesia
Time frame: 1-4 hours
Time before appearance of of hunger (evaluated by a score above 50/100 mm on analogic visual scale) after the end of hypnotic administration (propofol or sevoflurane).
6 secondary outcomes
Feeding comfort
Time frame: 1-4 hours
Post operative nausea and vomiting
Time frame: 1-4 hours
Validation of Chung score
Time frame: 1-4 hours
Change in plasmatic leptin level
Time frame: 0-3 hours
Change in plasmatic insulin level
Time frame: 0-3 hours
Change in plasmatic ghrelin level
Time frame: 0-3 hours
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 21 Dec 2017.
- Derived from this study: PubMed 31997087Besnier E, Perdrix A, Gillibert A, Selim J, Froemer B, Ghemired A, Berby B, Rives N, Dureuil B, Clavier T, Compere V. Postoperative hunger after outpatient surgery in patients anesthetized with propofol vs sevoflurane: a randomized-controlled trial. Can J Anaesth. 2020 May;67(5):550-559. doi: 10.1007/s12630-020-01584-w. Epub 2020 Jan 29.
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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.
Bertrand Dureuil, MD-PHD study chair
Departement of Anesthesia, University Hospital, Rouen
Emmanuel BESNIER, MD principal investigator
Departement of Anesthesia, University Hospital, Rouen
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 propofol and Sevoflurane in people with Ambulatory Surgery and Anesthesia, run by University Hospital, Rouen 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 8 inclusion and 15 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 21 Dec 2017. 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 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?
Time before recovery of hunger after general anesthesia (time frame: 1-4 hours). 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 NCT02272166, which also lists 1 linked publication.
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 21 Dec 2017.