ObesityPhase 4OBEREMNCT05026125
Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients
A Phase 4 study testing Remifentanil Injection and Remifentanil Injection plus 30% in people with Obesity and Bariatric Surgery Candidate, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study will assess the condition of orotracheal intubation in obese patients undergoing an elective bariatric surgery without the use of neuromuscular blocking agents. During the induction of general anesthesia, Propofol - Remifentanil combination will be used. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Intubation Complication
- What is being tested?
- Remifentanil Injection and Remifentanil Injection plus 30%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2022to 11 Aug 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient over 18 and under 60 years old.
- ASA score ≤ 3
- Elective bariatric surgery for patient with BMI between 35 and 60 or elective revision of a bariatric surgery for patient with a BMI over 30.
- Patient with a written consent obtained with accurate information.
Who cannot join
- Patient with risk of aspiration
- Difficult airway known (Cormack score 3 ou 4).
- Opioids addiction.
- Alcoholism
- Chronic use of Opioids
- Confirmed Allergy to Propofol or Remifentanil
- Severe chronic hepatic, kidney or respiratory failure
- Patient already enrolled in another clinical study interfering with this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients with Two Doses of Remifentanil: a Pilot Study
This study will assess the condition of orotracheal intubation in obese patients undergoing an elective bariatric surgery without the use of neuromuscular blocking agents.
During the induction of general anesthesia, Propofol - Remifentanil combination will be used.
The patients will be randomized in 2 groups with different doses of Remifentanil.
Read the detailed description
The prevalence of obesity increases steadily. For anesthesiologists, the airway management of obese patients is known to be difficult and at risk. Tracheal intubation needs to be successful quickly. Neuromuscular blocking agents allow this option but with a risk of anaphylaxis and respiratory complications. In fact, for many surgical procedures those drugs are not necessary.
Numerous studies in non-obese patients with the combination of Remifentanil and Propofol have shown adequate conditions for tracheal intubation without neuromuscular blocking drugs. This combination has never been studied in obese patient.
After randomization, induction of general anesthesia will be performed with 2,5 mg/kg of Propofol in association with either 3 µg/kg of Ideal Body Weight of Remifentanil, or 3 µg/kg + 30% of Ideal Body Weight of Remifentanil.
Minutes after the induction, orotracheal intubation will be performed, and the Intubation Difficulty Scale recorded.
Other data on hemodynamic, respiratory and airway management will be are collected during the surgery.
In the Post Anaesthetic Care Unit (PACU),Any symptoms of traumatic airway management or aspiration are collected.
Those data will be again looked for and collected on the day of the patient's discharge.
- Being tested
- Remifentanil Injection, Remifentanil Injection plus 30%
- Keywords
- tracheal intubation, obese patient, neuromuscular blocking agent, remifentanil
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil InjectionDrug
Also called orotracheal intubation, anesthesia, bariatric surgery
Injection of 3 μg/kg (Ideal Body Weight) of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery
Remifentanil Injection plus 30%Drug
Also called orotracheal intubation, anesthesia, bariatric surgery
Injection of 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Group control | Active comparator | 3 μg/kg (Ideal Body Weight) of Remifentanil Receives: Drug: Remifentanil Injection |
| Group Active | Experimental | 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil Receives: Drug: Remifentanil Injection plus 30% |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with excellent conditions of intubation
Intubation conditions will be assessed using the intubation conditions score proposed by Viby-Mogensen and al. (Scandinavian score). The score defines intubation conditions: excellent (all variables are excellent), good (all variables are either excellent or good), or poor (presence of a poor variable).
Measured: Baseline
Secondary outcomes (10)
Hemodynamic effects : hypotension
Percentage of patients with arterial hypotension (>20% decrease in mean arterial pressure) within 40 minutes of intubation
Measured: Baseline
Hemodynamic effects: bradycardia
Percentage of patients with bradycardia (>20% decrease in heart rate) within 40 minutes after intubation
Measured: Baseline
Hemodynamic effects: use of vasopressor drugs
Number of times vasopressor drugs were used.after intubation
Measured: Baseline
Respiratory effects: patients with desaturation day 0
Percentage of patients with desaturation (pulse oximetry (SpO2) below 90%.)
Measured: Baseline
Respiratory effects: patients with aspiration
Percentage of patients with aspiration (defined by the existence of gastric fluid in the oropharynx during direct laryngoscopy or by the diagnosis of pneumopathy within 48 hours of surgery).
Measured: From Baseline to day 2
Intubation complexity
Intubation complexity Measured by Difficult intubation score (IDS): scale from 0 (easy) to >5 (very difficult)
Measured: Baseline
Intubation difficulties with Cormack-Lehane classification
Intubation difficulties Measured by Cormack-Lehane classification (from 1: easy to 4 difficult)
Measured: Baseline
Percentage of use of the study's emergency
Intubation difficulties measured by percentage of use of the study's emergency
Measured: Baseline
Traumatic complications: anatomical lesion
Percentage of patients with an anatomical lesion (dental fracture, lip or mouth wound, oropharyngeal haemorrhage, vocal cord trauma)
Measured: Baseline
Traumatic complications: postoperative functional discomfort
Percentage of patients with postoperative functional discomfort (laryngeal pain, aphonia or dysphonia).
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start13 Jan 2022
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
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 ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Model description
- Prospective, randomized, controlled, double blinded and monocentric Pilot Study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Géraldine FAURE, Md, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026125
- Sponsor's protocol ID
- RC31/20/0443
- Other IDs
- 2021-000727-12
- Acronym
- OBEREM
- Status last verified
- Oct 2023
- First submitted
- 23 Aug 2021
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goudy P, Denis-Bonnin A, Thalamas C, Rousseau V, Migueres I, Faure G, Minville V. Quality of intubation using remifentanil in obese patients (OBEREM): A randomised, double-blind pilot trial. Anaesth Crit Care Pain Med. 2026 May;45(3):101673. doi: 10.1016/j.accpm.2025.101673. Epub 2025 Nov 7.
PubMed 41207379
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients with Two Doses of Remifentanil: a Pilot Study
- ClinicalTrials.gov ID
- NCT05026125
- Acronym / sponsor ID
- OBEREM / RC31/20/0443
- Keywords
- tracheal intubation, obese patient, neuromuscular blocking agent, remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 30 Aug 2021 (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 study will assess the condition of orotracheal intubation in obese patients undergoing an elective bariatric surgery without the use of neuromuscular blocking agents.
During the induction of general anesthesia, Propofol - Remifentanil combination will be used.
The patients will be randomized in 2 groups with different doses of Remifentanil.
Detailed description
The prevalence of obesity increases steadily. For anesthesiologists, the airway management of obese patients is known to be difficult and at risk. Tracheal intubation needs to be successful quickly. Neuromuscular blocking agents allow this option but with a risk of anaphylaxis and respiratory complications. In fact, for many surgical procedures those drugs are not necessary.
Numerous studies in non-obese patients with the combination of Remifentanil and Propofol have shown adequate conditions for tracheal intubation without neuromuscular blocking drugs. This combination has never been studied in obese patient.
After randomization, induction of general anesthesia will be performed with 2,5 mg/kg of Propofol in association with either 3 µg/kg of Ideal Body Weight of Remifentanil, or 3 µg/kg + 30% of Ideal Body Weight of Remifentanil.
Minutes after the induction, orotracheal intubation will be performed, and the Intubation Difficulty Scale recorded.
Other data on hemodynamic, respiratory and airway management will be are collected during the surgery.
In the Post Anaesthetic Care Unit (PACU),Any symptoms of traumatic airway management or aspiration are collected.
Those data will be again looked for and collected on the day of the patient's discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, double blinded and monocentric Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Group control | Active comparator | Drug: Remifentanil Injection3 μg/kg (Ideal Body Weight) of Remifentanil |
| Group Active | Experimental | Drug: Remifentanil Injection plus 30%3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient over 18 and under 60 years old.
- ASA score ≤ 3
- Elective bariatric surgery for patient with BMI between 35 and 60 or elective revision of a bariatric surgery for patient with a BMI over 30.
- Patient with a written consent obtained with accurate information.
Key exclusion criteria (8 listed)
- Patient with risk of aspiration
- Difficult airway known (Cormack score 3 ou 4).
- Opioids addiction.
- Alcoholism
- Chronic use of Opioids
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 |
|---|---|---|
| Remifentanil InjectionAlso: orotracheal intubation, anesthesia, bariatric surgeryInjection of 3 μg/kg (Ideal Body Weight) of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery | Drug | Group control |
| Remifentanil Injection plus 30%Also: orotracheal intubation, anesthesia, bariatric surgeryInjection of 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery | Drug | Group Active |
Primary outcome
percentage of patients with excellent conditions of intubation
Time frame: Baseline
Intubation conditions will be assessed using the intubation conditions score proposed by Viby-Mogensen and al. (Scandinavian score). The score defines intubation conditions: excellent (all variables are excellent), good (all variables are either excellent or good), or poor (presence of a poor variable).
10 secondary outcomes
Hemodynamic effects : hypotension
Time frame: Baseline
Hemodynamic effects: bradycardia
Time frame: Baseline
Hemodynamic effects: use of vasopressor drugs
Time frame: Baseline
Respiratory effects: patients with desaturation day 0
Time frame: Baseline
Respiratory effects: patients with aspiration
Time frame: From Baseline to day 2
Intubation complexity
Time frame: Baseline
Intubation difficulties with Cormack-Lehane classification
Time frame: Baseline
Percentage of use of the study's emergency
Time frame: Baseline
Traumatic complications: anatomical lesion
Time frame: Baseline
Traumatic complications: postoperative functional discomfort
Time frame: Day 2
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 18 Feb 2025.
- Derived from this study: PubMed 41207379Goudy P, Denis-Bonnin A, Thalamas C, Rousseau V, Migueres I, Faure G, Minville V. Quality of intubation using remifentanil in obese patients (OBEREM): A randomised, double-blind pilot trial. Anaesth Crit Care Pain Med. 2026 May;45(3):101673. doi: 10.1016/j.accpm.2025.101673. Epub 2025 Nov 7.
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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.
Géraldine FAURE, Md principal investigator
University Hospital, Toulouse
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 Remifentanil Injection and Remifentanil Injection plus 30% in people with Obesity and Bariatric Surgery Candidate, run by University Hospital, Toulouse 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 4 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: finished, as of the sponsor's last update on 18 Feb 2025. 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?
percentage of patients with excellent conditions of intubation (time frame: Baseline). 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 NCT05026125, 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 18 Feb 2025.