Hypoxemia During SurgeryNCT07187765
Respiratory Safety of Oliceridine During Sedated Gastrointestinal Endoscopy
A study testing Oliceridine and Sufentanil in people with Hypoxemia During Surgery and Gastrointestinal Endoscopy, run by Shiyou Wei at 1 site in China.
Trial summary
This study is a prospective, single-center, double-blind, randomized controlled trial designed to evaluate the effect of oliceridine versus sufentanil on the incidence of hypoxemia in adult patients undergoing gastrointestinal endoscopy under deep sedation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypoxemia During Surgery, Gastrointestinal Endoscopy
- What is being tested?
- Oliceridine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2025to 1 Dec 2025
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥ 18 years.
- Scheduled to undergo elective gastrointestinal endoscopy (gastroscopy or colonoscopy).
- American Society of Anesthesiologists (ASA) physical status I-III.
- No history of severe cardiopulmonary dysfunction or other major systemic disease.
Who cannot join
- Dementia or any cognitive impairment precluding provision of informed consent.
- Known contraindication to oliceridine.
- Chronic (long-term) opioid use.
- Any other medical or logistic condition that, in the investigator's judgment, makes the participant unsuitable for the study (specify reason).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Safety of Oliceridine in Propofol-Sedated Gastrointestinal Endoscopy: A Double-Blind, Randomized Controlled Trial
This study is a prospective, single-center, double-blind, randomized controlled trial designed to evaluate the effect of oliceridine versus sufentanil on the incidence of hypoxemia in adult patients undergoing gastrointestinal endoscopy under deep sedation. The trial will compare the rates of hypoxemia (defined as SpO₂ ≤92%) between the two analgesic regimens when combined with propofol. The primary aim is to determine whether oliceridine can reduce the incidence of hypoxemia compared to sufentanil during endoscopic procedures.
Read the detailed description
Gastrointestinal endoscopy is frequently performed under deep sedation to minimize patient discomfort caused by mechanical stimulation. Currently, the combination of propofol and short-acting opioids, such as sufentanil, is widely used for its reliable sedation and analgesia. However, opioid-induced respiratory depression (OIRD) remains a notable concern. Unlike traditional opioids, oliceridine is a synthetic μ-opioid receptor agonist that preferentially activates G protein pathways while substantially reducing β-arrestin pathway activation, which may lower the risk of opioid-related adverse events, including respiratory depression.
Previous studies suggest that oliceridine is as effective as morphine for pain control and may be associated with a lower incidence of adverse effects, particularly in elderly or obese surgical patients. Clinical data also suggest a lower risk of respiratory depression with oliceridine compared to traditional opioids, but the incidence of hypoxemia with oliceridine during real-world deep sedation remains unclear.
This study aims to enroll adult patients (aged ≥18 years, ASA I-III) scheduled for elective gastrointestinal endoscopy. Participants will be randomly assigned (1:1) to receive either oliceridine (1 mg for gastroscopy or 1.5 mg for colonoscopy) or sufentanil (5 μg for gastroscopy or 7.5 μg for colonoscopy), both in combination with propofol (1-2 mg/kg). The primary outcome is the incidence of SpO₂ ≤92% from the start of sedation to the end of the procedure.
- Being tested
- Oliceridine, Sufentanil
- Keywords
- Hypoxemia, Gastrointestinal Endoscopy, Oliceridine, Sufentanil, Deep Sedation
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
Also called TRV130
Oliceridine will be administered intravenously at a dose of 1 mg for gastroscopy or 1.5 mg for colonoscopy, in combination with propofol (1-2 mg/kg), to provide sedation and analgesia during gastrointestinal endoscopy.
SufentanilDrug
Also called Sufentanil Citrate
Sufentanil will be administered intravenously at a dose of 5 μg for gastroscopy or 7.5 μg for colonoscopy, in combination with propofol (1-2 mg/kg), to provide sedation and analgesia during gastrointestinal endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine Group | Experimental | Patients in this group will receive intravenous oliceridine (1 mg for gastroscopy or 1.5 mg for colonoscopy) combined with propofol (1-2 mg/kg) for sedation during gastrointestinal endoscopy. Receives: Drug: Oliceridine |
| Sufentanil Group | Active comparator | Patients in this group will receive intravenous sufentanil (5 μg for gastroscopy or 7.5 μg for colonoscopy) combined with propofol (1-2 mg/kg) for sedation during gastrointestinal endoscopy. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypoxemia (SpO₂ ≤92%) During Sedation for Gastrointestinal Endoscopy
The proportion of participants who experience hypoxemia, defined as a peripheral oxygen saturation (SpO₂) ≤92%, at any time from the start of sedation until the end of the endoscopic procedure.
Measured: From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes)
Secondary outcomes (1)
Incidence of secondary hypoxemic events during sedation for gastrointestinal endoscopy
The proportion of participants who experience any of the following between the start of sedation and the end of the endoscopic procedure :
- Severe hypoxemia, defined as lowest SpO₂ ≤ 85%
- A drop in SpO₂ of ≥ 5% relative to the participant's highest measured value during the sedation period
Measured: From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start22 Sep 2025
- Primary completion30 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemia During SurgeryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiyou Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Shiyou Wei, PhD, Study chair, 上海市肺科医院
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187765
- Sponsor's protocol ID
- 20250254
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Safety of Oliceridine in Propofol-Sedated Gastrointestinal Endoscopy: A Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07187765
- Acronym / sponsor ID
- 20250254
- Keywords
- Hypoxemia, Gastrointestinal Endoscopy, Oliceridine, Sufentanil, Deep Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Shiyou WeiUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 23 Sep 2025 (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 is a prospective, single-center, double-blind, randomized controlled trial designed to evaluate the effect of oliceridine versus sufentanil on the incidence of hypoxemia in adult patients undergoing gastrointestinal endoscopy under deep sedation. The trial will compare the rates of hypoxemia (defined as SpO₂ ≤92%) between the two analgesic regimens when combined with propofol. The primary aim is to determine whether oliceridine can reduce the incidence of hypoxemia compared to sufentanil during endoscopic procedures.
Detailed description
Gastrointestinal endoscopy is frequently performed under deep sedation to minimize patient discomfort caused by mechanical stimulation. Currently, the combination of propofol and short-acting opioids, such as sufentanil, is widely used for its reliable sedation and analgesia. However, opioid-induced respiratory depression (OIRD) remains a notable concern. Unlike traditional opioids, oliceridine is a synthetic μ-opioid receptor agonist that preferentially activates G protein pathways while substantially reducing β-arrestin pathway activation, which may lower the risk of opioid-related adverse events, including respiratory depression.
Previous studies suggest that oliceridine is as effective as morphine for pain control and may be associated with a lower incidence of adverse effects, particularly in elderly or obese surgical patients. Clinical data also suggest a lower risk of respiratory depression with oliceridine compared to traditional opioids, but the incidence of hypoxemia with oliceridine during real-world deep sedation remains unclear.
This study aims to enroll adult patients (aged ≥18 years, ASA I-III) scheduled for elective gastrointestinal endoscopy. Participants will be randomly assigned (1:1) to receive either oliceridine (1 mg for gastroscopy or 1.5 mg for colonoscopy) or sufentanil (5 μg for gastroscopy or 7.5 μg for colonoscopy), both in combination with propofol (1-2 mg/kg). The primary outcome is the incidence of SpO₂ ≤92% from the start of sedation to the end of the procedure.
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 |
|---|---|---|
| Oliceridine Group | Experimental | Drug: OliceridinePatients in this group will receive intravenous oliceridine (1 mg for gastroscopy or 1.5 mg for colonoscopy) combined with propofol (1-2 mg/kg) for sedation during gastrointestinal endoscopy. |
| Sufentanil Group | Active comparator | Drug: SufentanilPatients in this group will receive intravenous sufentanil (5 μg for gastroscopy or 7.5 μg for colonoscopy) combined with propofol (1-2 mg/kg) for sedation during gastrointestinal endoscopy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients aged ≥ 18 years.
- Scheduled to undergo elective gastrointestinal endoscopy (gastroscopy or colonoscopy).
- American Society of Anesthesiologists (ASA) physical status I-III.
- No history of severe cardiopulmonary dysfunction or other major systemic disease.
Key exclusion criteria (4 listed)
- Dementia or any cognitive impairment precluding provision of informed consent.
- Known contraindication to oliceridine.
- Chronic (long-term) opioid use.
- Any other medical or logistic condition that, in the investigator's judgment, makes the participant unsuitable for the study (specify reason).
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 |
|---|---|---|
| OliceridineAlso: TRV130Oliceridine will be administered intravenously at a dose of 1 mg for gastroscopy or 1.5 mg for colonoscopy, in combination with propofol (1-2 mg/kg), to provide sedation and analgesia during gastrointestinal endoscopy. | Drug | Oliceridine Group |
| SufentanilAlso: Sufentanil CitrateSufentanil will be administered intravenously at a dose of 5 μg for gastroscopy or 7.5 μg for colonoscopy, in combination with propofol (1-2 mg/kg), to provide sedation and analgesia during gastrointestinal endoscopy. | Drug | Sufentanil Group |
Primary outcome
Incidence of Hypoxemia (SpO₂ ≤92%) During Sedation for Gastrointestinal Endoscopy
Time frame: From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes)
The proportion of participants who experience hypoxemia, defined as a peripheral oxygen saturation (SpO₂) ≤92%, at any time from the start of sedation until the end of the endoscopic procedure.
1 secondary outcome
Incidence of secondary hypoxemic events during sedation for gastrointestinal endoscopy
Time frame: From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes)
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 4 Sep 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. This study is not recruiting at the moment.
Shiyou Wei, PhD study chair
上海市肺科医院
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oliceridine and Sufentanil in people with Hypoxemia During Surgery and Gastrointestinal Endoscopy, run by Shiyou Wei at 1 site in China.
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 4 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 4 Sep 2026. 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 China. 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?
Incidence of Hypoxemia (SpO₂ ≤92%) During Sedation for Gastrointestinal Endoscopy (time frame: From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes)). 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 4 Sep 2026.