General AnesthesiaCOCOPOPONONCT04492813
Plasmatic Concentrations of Propofol and Remifentanil in Obese and Non Obese Patients.
A study testing Pharmacokinetic of propofol and remifentanil in people with General Anesthesia and Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This prospective monocentric phamacokinetics study aims to compare plasmatic concentrations of Propofol and Remifentanil required to target a specific range of monitored anesthesia and analgesia during sus-mesocolic surgery in obese and non obese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia, Obesity
- What is being tested?
- Pharmacokinetic of propofol and remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2018to 25 May 2021
- Phase
- Interventional
- 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
- Obese patients group:
- Age ≥ 18 years old
- Severe and morbidly obese patients (35kg / m2≤IMC <55kg / m2).
- Patients undergoing general anesthesia for laparoscopic susmesocolic surgery (bariatric surgery or cholecystectomy).
- Patients who have given their consent in the manner described by the public health law of August 9, 2004.
- Patients benefiting from a Social Security scheme.
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- Group of non-obese patients:
- Age ≥ 18 years old
- Patients with normal weight or slightly overweight (19 <BMI <30).
- Patients receiving general anesthesia for laparoscopic susmesocolic surgery (cholecystectomy).
- Patients who have given their consent in the manner described by the public health law of August 9, 2004.
- Patients benefiting from a Social Security scheme.
Who cannot join
- Patient refusal
- Age <18 years old
- Protected adults and vulnerable persons
- Pace maker
- General anesthesia in the 24 hours preceding this surgery
- Proven or suspected dysautonomia
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- Premedication by gabapentin Neurontin °
- Locoregional peri-medullary analgesia technique used concomitantly during the pre- and intraoperative period.
- Unbalanced dysrhythmic heart disease (AC / FA; extrasystoles; non-sinus rhythm)
- Pregnant or breastfeeding woman
- Intubation impossible planned
- Hypersensitivity to the products used
- Allergy to peanut or soy
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand
Clermont-Ferrand, Puy De Dôme, 63000
About this study
Official title: Comparison of Plasmatic Concentrations of Propofol and Remifentanil During Monitored Anesthesia in Obese and Non Obese Patients.
This prospective monocentric phamacokinetics study aims to compare plasmatic concentrations of Propofol and Remifentanil required to target a specific range of monitored anesthesia and analgesia during sus-mesocolic surgery in obese and non obese patients.
Read the detailed description
Remifentanil and Propofol are administered intravenously as an opioid pain reliever and hypnotic pain reliever during anesthesia. Their advantages are numerous: short half-life allowing anesthesia and rapid awakening, little accumulation, allowing to adapt the level of anesthesia or sedation to each patient, few side effects.
Entropy° is an index derived from the electroencephalographic signal of patients, validated for the evaluation of the level of narcosis during general anesthesia.
ANI ° (nociception index analgesia) is an index using the ventilatory physiological variability of the sinus rhythm validated to monitor patient's analgesia during general anesthesia.
These non-invasive means of analgesia and sedation monitoring allows the clinician to ensure satisfactory levels of anesthesia by administering products at minimum effective doses.
The authors propose to determine whether, for a comparable target effect (analgesia and monitored sedation), plasmatic concentrations and administration rates of propofol and remifentanil necessary during general anesthesia for a comparable surgical stimulus are the same in populations of obese and non obese patients.
- Conditions
- General Anesthesia, Obesity
- Being tested
- Pharmacokinetic of propofol and remifentanil
- Keywords
- General anesthesia, Obesity, Propofol pharmacokinetic, Remifentanyl pharmacokinetic
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic of propofol and remifentanilDrug
Pharmacokinetic of propofol and remifentanil in both population: Obese and non Obese patients
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Experimental | Severe and morbidly obese patients (35²≤BMI <55) Receives: Drug: Pharmacokinetic of propofol and remifentanil |
| Non Obese patients | Active comparator | Patients with normal weight or slightly overweight (19 <BMI <30). Receives: Drug: Pharmacokinetic of propofol and remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Propofol
Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
Measured: 5 minutes after the insufflation of the pneumoperitoneum
Plasma concentration of Propofol
Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
Measured: 5 minutes after completion of the gastric slice or ligation of the bile ducts
Plasma concentration of Propofol
Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
Measured: At time of removing surgical specimen from the abdomen
Plasma concentration of Propofol
Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
Measured: At the exsufflation of the pneumoperitoneum
Plasma concentration of Remifentanil
Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
Measured: 5 minutes after the insufflation of the pneumoperitoneum
Plasma concentration of Remifentanil
Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
Measured: 5 minutes after completion of the gastric slice or ligation of the bile ducts
Plasma concentration of Remifentanil
Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
Measured: At time of removing surgical specimen from the abdomen
Plasma concentration of Remifentanil
Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
Measured: At the exsufflation of the pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start20 Dec 2018
- Primary completion25 Jan 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Each obese patient is matched with a non-obese patient by considering a pairing according to age (more or less 5 years), gender and renal function (more or less 10ml / min / 1.73m² creatinine clearance).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Etienne Bazin, Pr, Principal investigator, Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492813
- Sponsor's protocol ID
- COCOPOPONO
- Acronym
- COCOPOPONO
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plasmatic Concentrations of Propofol and Remifentanil During Monitored Anesthesia in Obese and Non Obese Patients.
- ClinicalTrials.gov ID
- NCT04492813
- Acronym / sponsor ID
- COCOPOPONO / COCOPOPONO
- Conditions
- General Anesthesia, Obesity
- Keywords
- General anesthesia, Obesity, Propofol pharmacokinetic, Remifentanyl pharmacokinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 30 Jul 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.
This prospective monocentric phamacokinetics study aims to compare plasmatic concentrations of Propofol and Remifentanil required to target a specific range of monitored anesthesia and analgesia during sus-mesocolic surgery in obese and non obese patients.
Detailed description
Remifentanil and Propofol are administered intravenously as an opioid pain reliever and hypnotic pain reliever during anesthesia. Their advantages are numerous: short half-life allowing anesthesia and rapid awakening, little accumulation, allowing to adapt the level of anesthesia or sedation to each patient, few side effects.
Entropy° is an index derived from the electroencephalographic signal of patients, validated for the evaluation of the level of narcosis during general anesthesia.
ANI ° (nociception index analgesia) is an index using the ventilatory physiological variability of the sinus rhythm validated to monitor patient's analgesia during general anesthesia.
These non-invasive means of analgesia and sedation monitoring allows the clinician to ensure satisfactory levels of anesthesia by administering products at minimum effective doses.
The authors propose to determine whether, for a comparable target effect (analgesia and monitored sedation), plasmatic concentrations and administration rates of propofol and remifentanil necessary during general anesthesia for a comparable surgical stimulus are the same in populations of obese and non obese patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each obese patient is matched with a non-obese patient by considering a pairing according to age (more or less 5 years), gender and renal function (more or less 10ml / min / 1.73m² creatinine clearance).
| Arm | Type | Receives |
|---|---|---|
| Obese patients | Experimental | Drug: Pharmacokinetic of propofol and remifentanilSevere and morbidly obese patients (35²≤BMI <55) |
| Non Obese patients | Active comparator | Drug: Pharmacokinetic of propofol and remifentanilPatients with normal weight or slightly overweight (19 <BMI <30). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years old
- Severe and morbidly obese patients (35kg / m2≤IMC <55kg / m2).
- Patients undergoing general anesthesia for laparoscopic susmesocolic surgery (bariatric surgery or cholecystectomy).
- Patients who have given their consent in the manner described by the public health law of August 9, 2004.
- Patients benefiting from a Social Security scheme.
Key exclusion criteria (13 listed)
- Patient refusal
- Age <18 years old
- Protected adults and vulnerable persons
- Pace maker
- General anesthesia in the 24 hours preceding this surgery
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 |
|---|---|---|
| Pharmacokinetic of propofol and remifentanilPharmacokinetic of propofol and remifentanil in both population: Obese and non Obese patients | Drug | Non Obese patients, Obese patients |
Primary outcome
Plasma concentration of Propofol
Time frame: 5 minutes after the insufflation of the pneumoperitoneum
Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
Plasma concentration of Propofol
Time frame: 5 minutes after completion of the gastric slice or ligation of the bile ducts
Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
Plasma concentration of Propofol
Time frame: At time of removing surgical specimen from the abdomen
Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
Plasma concentration of Propofol
Time frame: At the exsufflation of the pneumoperitoneum
Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
Plasma concentration of Remifentanil
Time frame: 5 minutes after the insufflation of the pneumoperitoneum
Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
Plasma concentration of Remifentanil
Time frame: 5 minutes after completion of the gastric slice or ligation of the bile ducts
Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
Plasma concentration of Remifentanil
Time frame: At time of removing surgical specimen from the abdomen
Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
Plasma concentration of Remifentanil
Time frame: At the exsufflation of the pneumoperitoneum
Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
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 25 Aug 2021.
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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.
Jean-Etienne Bazin, Pr principal investigator
Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacokinetic of propofol and remifentanil in people with General Anesthesia and Obesity, run by University Hospital, Clermont-Ferrand 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 12 inclusion and 13 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 25 Aug 2021. 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.
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?
Plasma concentration of Propofol (time frame: 5 minutes after the insufflation of the pneumoperitoneum). The study lists 8 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 25 Aug 2021.