ObesityPhase 4NCT07759778
Oliceridine-Propofol Dose for Gastroscope Insertion in Obese Patients
A Phase 4 study testing Low-Dose Oliceridine Group and High-Dose Oliceridine Group in people with Obesity and Gastrointestinal Endoscopy, run by Lu Yi.
Trial summary
The purpose of this study is to find the right dose of two medications, oliceridine and propofol, when used together for sedation in patients with obesity undergoing a painless gastroscope procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Gastrointestinal Endoscopy
- What is being tested?
- Low-Dose Oliceridine Group and High-Dose Oliceridine Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- 18-65 years old, regardless of sex
- BMI≥28 kg/m2
- The American Society of Anesthesiologists (ASA) has a rating of II-III
- Plan to undergo elective painless digestive endoscopy
- The subjects understand the purpose and steps of this experiment, voluntarily participate in this experiment, and sign a written informed consent
Who cannot join
- Known to be allergic to drugs used in the examination process
- Diagnosed respiratory diseases (asthma, bronchitis, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, lung cancer or upper respiratory tract infection)
- Cardiovascular diseases (heart failure, unstable angina pectoris, myocardial infarction or arrhythmia) have been diagnosed
- Current hepatic insufficiency (Child-Pugh grade B or above) or renal insufficiency (estimated glomerular filtration rate < 60 ml/min/1.73 m2)
- History of difficult airway (Mallampati Grade IV or expected difficult airway)
- Long-term use of opioids (regular use of opioids for more than 7 days within 3 months before operation)
- Pregnant or lactating women
- Mental illness or cognitive dysfunction can not cooperate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploration of the Effective Dose of Oliceridine Combined With Propofol for Gastroscope Insertion in Obese Patients Undergoing Painless Gastrointestinal Endoscopy
The purpose of this study is to find the right dose of two medications, oliceridine and propofol, when used together for sedation in patients with obesity undergoing a painless gastroscope procedure.
Currently, standard sedation methods using other opioids can sometimes cause breathing problems, especially in patients with obesity. Oliceridine is a newer medication that may provide good pain relief with a lower risk of these side effects. However, the best dose of propofol when combined with oliceridine for this specific patient group is not yet clear.
This study will enroll patients with obesity (BMI ≥ 28 kg/m²) who are scheduled for a routine painless gastroscopy. Participants will receive the study medications during their procedure, and the medical team will carefully monitor their vital signs and sedation level. The study aims to find the most effective and safe dose combination to help guide future clinical practice.
- Conditions
- Obesity, Gastrointestinal Endoscopy
- Being tested
- Low-Dose Oliceridine Group, High-Dose Oliceridine Group
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose Oliceridine GroupDrug
Oliceridine at a low fixed dose is administered intravenously, followed by propofol at an initial dose of 2 mg/kg based on lean body weight.
High-Dose Oliceridine GroupDrug
Oliceridine at a high fixed dose is administered intravenously, followed by propofol at an initial dose of 1.5 mg/kg based on lean body weight.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Oliceridine Group | Experimental | Not described Receives: Drug: Low-Dose Oliceridine Group |
| High-Dose Oliceridine Group | Experimental | Not described Receives: Drug: High-Dose Oliceridine Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Dose (ED50 and ED95) of Propofol Combined with Oliceridine for Gastroscope Insertion
The ED50 and ED95 of propofol (based on lean body weight) required to achieve successful sedation during gastroscope insertion, estimated using the biased coin design up-and-down method with isotonic or central ordered regression. Positive response is defined as: cough or body movement ≥ grade 2 during gastroscope insertion, requiring additional propofol.
Measured: Within 3 minutes after gastroscope insertion
Secondary outcomes (5)
Time to Loss of Consciousness
Time from initiation of propofol administration to loss of consciousness, defined as MOAA/S score ≤ 1.
Measured: Within 5 minutes
Procedure Duration
Total time from gastroscope insertion to completion of the endoscopic examination.
Measured: Periprocedural
Recovery Time
Time from the end of the initial propofol dose administration to the first of three consecutive MOAA/S scores of 5, indicating full alertness.
Measured: Within 30 minutes post-procedure
Total Propofol Dose
Total dose of propofol administered during the entire procedure, including the initial dose and any rescue boluses.
Measured: Periprocedural
Incidence of Adverse Events
(1) Respiratory depression: SpO₂ < 90% despite oxygen supplementation after relief of upper airway obstruction, or absence of spontaneous breathing; (2) Hypotension: mean arterial pressure (MAP) decrease > 20% from pre-sedation baseline, or systolic blood pressure ≤ 90 mmHg, from drug administration until discharge from the post-anesthesia care unit; (3) Bradycardia: heart rate < 50 beats per minute.
Measured: From drug administration to PACU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lu Yi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Yi, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759778
- Sponsor's protocol ID
- SAHoWMU-CR2026-03-117
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Effective Dose of Oliceridine Combined With Propofol for Gastroscope Insertion in Obese Patients Undergoing Painless Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT07759778
- Acronym / sponsor ID
- SAHoWMU-CR2026-03-117
- Conditions
- Obesity, Gastrointestinal Endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lu YiUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Aug 2026 (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.
The purpose of this study is to find the right dose of two medications, oliceridine and propofol, when used together for sedation in patients with obesity undergoing a painless gastroscope procedure.
Currently, standard sedation methods using other opioids can sometimes cause breathing problems, especially in patients with obesity. Oliceridine is a newer medication that may provide good pain relief with a lower risk of these side effects. However, the best dose of propofol when combined with oliceridine for this specific patient group is not yet clear.
This study will enroll patients with obesity (BMI ≥ 28 kg/m²) who are scheduled for a routine painless gastroscopy. Participants will receive the study medications during their procedure, and the medical team will carefully monitor their vital signs and sedation level. The study aims to find the most effective and safe dose combination to help guide future clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Oliceridine Group | Experimental | Drug: Low-Dose Oliceridine Group |
| High-Dose Oliceridine Group | Experimental | Drug: High-Dose Oliceridine Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years old, regardless of sex
- BMI≥28 kg/m2
- The American Society of Anesthesiologists (ASA) has a rating of II-III
- Plan to undergo elective painless digestive endoscopy
- The subjects understand the purpose and steps of this experiment, voluntarily participate in this experiment, and sign a written informed consent
Key exclusion criteria (8 listed)
- Known to be allergic to drugs used in the examination process
- Diagnosed respiratory diseases (asthma, bronchitis, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, lung cancer or upper respiratory tract infection)
- Cardiovascular diseases (heart failure, unstable angina pectoris, myocardial infarction or arrhythmia) have been diagnosed
- Current hepatic insufficiency (Child-Pugh grade B or above) or renal insufficiency (estimated glomerular filtration rate < 60 ml/min/1.73 m2)
- History of difficult airway (Mallampati Grade IV or expected difficult airway)
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 |
|---|---|---|
| Low-Dose Oliceridine GroupOliceridine at a low fixed dose is administered intravenously, followed by propofol at an initial dose of 2 mg/kg based on lean body weight. | Drug | Low-Dose Oliceridine Group |
| High-Dose Oliceridine GroupOliceridine at a high fixed dose is administered intravenously, followed by propofol at an initial dose of 1.5 mg/kg based on lean body weight. | Drug | High-Dose Oliceridine Group |
Primary outcome
Effective Dose (ED50 and ED95) of Propofol Combined with Oliceridine for Gastroscope Insertion
Time frame: Within 3 minutes after gastroscope insertion
The ED50 and ED95 of propofol (based on lean body weight) required to achieve successful sedation during gastroscope insertion, estimated using the biased coin design up-and-down method with isotonic or central ordered regression. Positive response is defined as: cough or body movement ≥ grade 2 during gastroscope insertion, requiring additional propofol.
5 secondary outcomes
Time to Loss of Consciousness
Time frame: Within 5 minutes
Procedure Duration
Time frame: Periprocedural
Recovery Time
Time frame: Within 30 minutes post-procedure
Total Propofol Dose
Time frame: Periprocedural
Incidence of Adverse Events
Time frame: From drug administration to PACU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-Dose Oliceridine Group and High-Dose Oliceridine Group in people with Obesity and Gastrointestinal Endoscopy, run by Lu Yi.
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 5 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Lu (+86-15858805272, luyi1111.cool@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Dose (ED50 and ED95) of Propofol Combined with Oliceridine for Gastroscope Insertion (time frame: Within 3 minutes after gastroscope insertion). 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 Aug 2026.