OliceridineNCT07154979
Oliceridine Dose for Tracheal Intubation Hemodynamic Elevation: Up-and-Down Trial
A study testing Oliceridine Injection in people with Oliceridine, run by Shiyou Wei at 1 site in China.
Trial summary
This is a clinical trial using an up-and-down sequential design, aiming to investigate the median effective dose (ED50) and 95% effective dose (ED95) of oliceridine for inhibiting hyperdynamic responses induced by tracheal intubation during general anesthesia induction. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Oliceridine
- What is being tested?
- Oliceridine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2025to 11 Sep 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
- Elective surgery requiring general anesthesia with tracheal intubation
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status I-III
- BMI<25
Who cannot join
- At rest in the operating room, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg or heart rate ≥ 110 bpm
- Preoperative long-term use of analgesic or sedative medications
- Pregnancy, breastfeeding, known or planned pregnancy
- Known allergy or hypersensitivity to oliceridine or any study medication components
- History of psychiatric illness or inability to communicate effectively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective Dose of Oliceridine for Inhibiting Hemodynamic Elevation Induced by Tracheal Intubation: An Up-and-Down Sequential Trial
This is a clinical trial using an up-and-down sequential design, aiming to investigate the median effective dose (ED50) and 95% effective dose (ED95) of oliceridine for inhibiting hyperdynamic responses induced by tracheal intubation during general anesthesia induction. The study will enroll patients undergoing elective tracheal intubation under general anesthesia, stratified into young (18-65 years) and elderly (≥65 years) groups. By dynamically adjusting oliceridine doses, the optimal induction dose in different age groups will be evaluated to provide reference for rational clinical medication.
Read the detailed description
- Study Objectives To determine the ED50 and ED95 of oliceridine in inhibiting tracheal intubation-induced hyperdynamic responses (e.g., increased blood pressure and heart rate) during general anesthesia induction, and to provide dose evidence for individualized anesthesia induction protocols.
- Study Design Type: A dynamic dose-finding clinical trial using the modified Dixon up-and-down sequential design. Sample Size: 35 cases per group anticipated, with trial termination after 7 cross-overs between positive and negative responses (i.e., transitions in whether hemodynamic responses exceed 20% of baseline). Grouping: Stratified by age into young group (18-65 years) and elderly group (≥65 years).
- Study Participants Inclusion Criteria: Patients undergoing elective tracheal intubation under general anesthesia; Aged ≥18 years; American Society of Anesthesiologists (ASA) physical status Ⅰ-Ⅲ; Body mass index (BMI) < 25. Exclusion Criteria: Systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥110 mmHg, or heart rate ≥110 beats/min at rest upon admission to the operating room; Long-term use of analgesics or sedatives before surgery; Pregnancy, lactation, or planned pregnancy; Allergy to oliceridine; Mental illness or inability to communicate normally.
- Trial Procedures Screening Period (-7 to 0 days): Informed consent signed; collection of basic information (age, ASA class, etc.); baseline blood pressure and heart rate monitored. Anesthesia Induction and Intubation: Routine vital sign monitoring and intravenous access established upon patient admission. Initial doses: 45 μg/kg for the young group and 42 μg/kg for the elderly group. Subsequent doses adjusted based on intubation response (increase by 3 μg/kg for positive response, decrease by 3 μg/kg for negative response). Administration sequence: Intravenous oliceridine → propofol 2 mg/kg 2 minutes later → rocuronium 0.6 mg/kg after loss of consciousness (MOAA/S score ≤1) → tracheal intubation after neuromuscular blockade. Anesthesia Maintenance: Propofol (4-8 mg/kg/h) and remifentanil (0.05-0.1 μg/kg/min) infused continuously; rocuronium added intermittently; protective ventilation strategy applied.
- Outcome Measures Primary Measures: ED50 and ED95 of oliceridine for inhibiting post-intubation hyperdynamic responses. Secondary Measures: Incidence of hyperdynamic responses within 3 minutes after intubation; Blood pressure (SBP, DBP) and heart rate at baseline, 2 minutes after drug administration, before intubation, and within 3 minutes after intubation; Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score; Adverse events (arrhythmia, coughing, allergic reactions, etc.).
- Statistical Methods Data analysis will be performed using R software. Quantitative data will be expressed as mean±standard deviation or median (interquartile range), and qualitative data as frequency (percentage). Probit analysis will be used to calculate ED50 and its 95% confidence interval. A P-value <0.05 will be considered statistically significant.
- Conditions
- Oliceridine
- Being tested
- Oliceridine Injection
- Keywords
- oliceridine, dose-finding, µ-opioid receptor G-protein-biased agonist, up-and-down sequential design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oliceridine InjectionDrug
Also called TRV130
Adult participants receive a single IV bolus of oliceridine (initial dose 45 µg/kg for ages 18-65 y or 40 µg/kg for ≥65 y). Two minutes later, propofol 2 mg/kg IV is administered. Upon loss of consciousness (MOAA/S ≤ 1), rocuronium 0.6 mg/kg IV is given. Direct laryngoscopic tracheal intubation is performed after full muscle relaxation. Blood pressure and heart rate are recorded at baseline, 2 min post-oliceridine, immediately pre-intubation, and for 3 min post-intubation. A "positive" hemodynamic response is defined as ≥ 20% increase in MAP or HR, HR ≥ 120 bpm, or SBP ≥ 180 mmHg. Subsequent oliceridine doses are adjusted ± 3 µg/kg based on the prior patient's response until seven response crossovers are observed, allowing estimation of ED₅₀ and ED₉₅.
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine Up-and-Down Sequential Dose-Finding Arm | Experimental | In this single-group, up-and-down sequential design, adult patients receive a single intravenous bolus of oliceridine.
* Initial dose: 45 µg/kg for ages 18-65 years; 40 µg/kg for ≥ 65 years
* Two minutes later: propofol 2 mg/kg iv
* At loss of consciousness (MOAA/S ≤ 1): rocuronium 0.6 mg/kg iv
* Direct-laryngoscope tracheal intubation performed upon full muscle relaxation
* Hemodynamic variables (BP, HR) recorded at baseline, 2 min post-oliceridine, immediately pre-intubation, and for 3 min post-intubation
* A "positive" response (hemodynamic surge) is defined as ≥ 20% increase in MAP or HR, HR ≥ 120 bpm, or SBP ≥ 180 mmHg
* Next patient's oliceridine dose is adjusted ± 3 µg/kg according to the preceding patient's response
* Sequential dosing continues until seven crossovers are observed, allowing estimation of ED₅₀ and ED₉₅. Receives: Drug: Oliceridine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED₉₅ of oliceridine for suppression of tracheal intubation-induced hemodynamic response
95% effective dose (ED₉₅) of oliceridine required to prevent a positive hemodynamic response-defined as ≥ 20% increase in mean arterial pressure or heart rate, heart rate ≥ 120 bpm, or systolic blood pressure ≥ 180 mmHg-within 3 minutes after tracheal intubation during general anesthesia induction, estimated by probit regression analysis of up-and-down sequential dosing data.
Measured: From the start of intubation to 3 minutes after the end of intubation
ED₅₀ of oliceridine for suppression of tracheal intubation-induced hemodynamic response
Median effective dose (ED₅₀) of oliceridine required to prevent a positive hemodynamic response-defined as ≥ 20% increase in mean arterial pressure or heart rate, heart rate ≥ 120 bpm, or systolic blood pressure ≥ 180 mmHg-within 3 minutes after tracheal intubation during general anesthesia induction, estimated by probit regression analysis of up-and-down sequential dosing data.
Measured: From the start of intubation to 3 minutes after the end of intubation
Secondary outcomes (1)
The number of cases with coughing
During anesthesia induction, intravenous injection of opioids may cause coughing. During the intubation process, coughing may occur due to airway stimulation.
Measured: From the start of anesthesia induction to 3 minutes after the end of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start4 Sep 2025
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OliceridineStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single-group, up-and-down sequential dose-finding design to determine the ED₅₀ and ED₉₅ of oliceridine for suppression of hemodynamic responses to tracheal intubation.
- Masking
- None (open label)
- Enrolment
- 58 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, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154979
- Sponsor's protocol ID
- 20250250
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Dose of Oliceridine for Inhibiting Hemodynamic Elevation Induced by Tracheal Intubation: An Up-and-Down Sequential Trial
- ClinicalTrials.gov ID
- NCT07154979
- Acronym / sponsor ID
- 20250250
- Conditions
- Oliceridine
- Keywords
- oliceridine, dose-finding, µ-opioid receptor G-protein-biased agonist, up-and-down sequential design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Shiyou WeiUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 4 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 is a clinical trial using an up-and-down sequential design, aiming to investigate the median effective dose (ED50) and 95% effective dose (ED95) of oliceridine for inhibiting hyperdynamic responses induced by tracheal intubation during general anesthesia induction. The study will enroll patients undergoing elective tracheal intubation under general anesthesia, stratified into young (18-65 years) and elderly (≥65 years) groups. By dynamically adjusting oliceridine doses, the optimal induction dose in different age groups will be evaluated to provide reference for rational clinical medication.
Detailed description
- Study Objectives To determine the ED50 and ED95 of oliceridine in inhibiting tracheal intubation-induced hyperdynamic responses (e.g., increased blood pressure and heart rate) during general anesthesia induction, and to provide dose evidence for individualized anesthesia induction protocols.
- Study Design Type: A dynamic dose-finding clinical trial using the modified Dixon up-and-down sequential design. Sample Size: 35 cases per group anticipated, with trial termination after 7 cross-overs between positive and negative responses (i.e., transitions in whether hemodynamic responses exceed 20% of baseline). Grouping: Stratified by age into young group (18-65 years) and elderly group (≥65 years).
- Study Participants Inclusion Criteria: Patients undergoing elective tracheal intubation under general anesthesia; Aged ≥18 years; American Society of Anesthesiologists (ASA) physical status Ⅰ-Ⅲ; Body mass index (BMI) < 25. Exclusion Criteria: Systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥110 mmHg, or heart rate ≥110 beats/min at rest upon admission to the operating room; Long-term use of analgesics or sedatives before surgery; Pregnancy, lactation, or planned pregnancy; Allergy to oliceridine; Mental illness or inability to communicate normally.
- Trial Procedures Screening Period (-7 to 0 days): Informed consent signed; collection of basic information (age, ASA class, etc.); baseline blood pressure and heart rate monitored. Anesthesia Induction and Intubation: Routine vital sign monitoring and intravenous access established upon patient admission. Initial doses: 45 μg/kg for the young group and 42 μg/kg for the elderly group. Subsequent doses adjusted based on intubation response (increase by 3 μg/kg for positive response, decrease by 3 μg/kg for negative response). Administration sequence: Intravenous oliceridine → propofol 2 mg/kg 2 minutes later → rocuronium 0.6 mg/kg after loss of consciousness (MOAA/S score ≤1) → tracheal intubation after neuromuscular blockade. Anesthesia Maintenance: Propofol (4-8 mg/kg/h) and remifentanil (0.05-0.1 μg/kg/min) infused continuously; rocuronium added intermittently; protective ventilation strategy applied.
- Outcome Measures Primary Measures: ED50 and ED95 of oliceridine for inhibiting post-intubation hyperdynamic responses. Secondary Measures: Incidence of hyperdynamic responses within 3 minutes after intubation; Blood pressure (SBP, DBP) and heart rate at baseline, 2 minutes after drug administration, before intubation, and within 3 minutes after intubation; Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score; Adverse events (arrhythmia, coughing, allergic reactions, etc.).
- Statistical Methods Data analysis will be performed using R software. Quantitative data will be expressed as mean±standard deviation or median (interquartile range), and qualitative data as frequency (percentage). Probit analysis will be used to calculate ED50 and its 95% confidence interval. A P-value <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-group, up-and-down sequential dose-finding design to determine the ED₅₀ and ED₉₅ of oliceridine for suppression of hemodynamic responses to tracheal intubation.
| Arm | Type | Receives |
|---|---|---|
| Oliceridine Up-and-Down Sequential Dose-Finding Arm | Experimental | Drug: Oliceridine InjectionIn this single-group, up-and-down sequential design, adult patients receive a single intravenous bolus of oliceridine. * Initial dose: 45 µg/kg for ages 18-65 years; 40 µg/kg for ≥ 65 years * Two minutes later: propofol 2 mg/kg iv * At loss of consciousness (MOAA/S ≤ 1): rocuronium 0.6 mg/kg iv * Direct-laryngoscope tracheal intubation performed upon full muscle relaxation * Hemodynamic variables (BP, HR) recorded at baseline, 2 min post-oliceridine, immediately pre-intubation, and for 3 min post-intubation * A "positive" response (hemodynamic surge) is defined as ≥ 20% increase in MAP or HR, HR ≥ 120 bpm, or SBP ≥ 180 mmHg * Next patient's oliceridine dose is adjusted ± 3 µg/kg according to the preceding patient's response * Sequential dosing continues until seven crossovers are observed, allowing estimation of ED₅₀ and ED₉₅. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective surgery requiring general anesthesia with tracheal intubation
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status I-III
- BMI<25
Key exclusion criteria (5 listed)
- At rest in the operating room, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg or heart rate ≥ 110 bpm
- Preoperative long-term use of analgesic or sedative medications
- Pregnancy, breastfeeding, known or planned pregnancy
- Known allergy or hypersensitivity to oliceridine or any study medication components
- History of psychiatric illness or inability to communicate effectively
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 |
|---|---|---|
| Oliceridine InjectionAlso: TRV130Adult participants receive a single IV bolus of oliceridine (initial dose 45 µg/kg for ages 18-65 y or 40 µg/kg for ≥65 y). Two minutes later, propofol 2 mg/kg IV is administered. Upon loss of consciousness (MOAA/S ≤ 1), rocuronium 0.6 mg/kg IV is given. Direct laryngoscopic tracheal intubation is performed after full muscle relaxation. Blood pressure and heart rate are recorded at baseline, 2 min post-oliceridine, immediately pre-intubation, and for 3 min post-intubation. A "positive" hemodynamic response is defined as ≥ 20% increase in MAP or HR, HR ≥ 120 bpm, or SBP ≥ 180 mmHg. Subsequent oliceridine doses are adjusted ± 3 µg/kg based on the prior patient's response until seven response crossovers are observed, allowing estimation of ED₅₀ and ED₉₅. | Drug | Oliceridine Up-and-Down Sequential Dose-Finding Arm |
Primary outcome
ED₉₅ of oliceridine for suppression of tracheal intubation-induced hemodynamic response
Time frame: From the start of intubation to 3 minutes after the end of intubation
95% effective dose (ED₉₅) of oliceridine required to prevent a positive hemodynamic response-defined as ≥ 20% increase in mean arterial pressure or heart rate, heart rate ≥ 120 bpm, or systolic blood pressure ≥ 180 mmHg-within 3 minutes after tracheal intubation during general anesthesia induction, estimated by probit regression analysis of up-and-down sequential dosing data.
ED₅₀ of oliceridine for suppression of tracheal intubation-induced hemodynamic response
Time frame: From the start of intubation to 3 minutes after the end of intubation
Median effective dose (ED₅₀) of oliceridine required to prevent a positive hemodynamic response-defined as ≥ 20% increase in mean arterial pressure or heart rate, heart rate ≥ 120 bpm, or systolic blood pressure ≥ 180 mmHg-within 3 minutes after tracheal intubation during general anesthesia induction, estimated by probit regression analysis of up-and-down sequential dosing data.
1 secondary outcome
The number of cases with coughing
Time frame: From the start of anesthesia induction to 3 minutes after the end of intubation
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 Nov 2025.
- 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
Shanghai Pulmonary Hospital, Shanghai, China
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 Injection in people with Oliceridine, 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 5 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 Nov 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 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?
ED₉₅ of oliceridine for suppression of tracheal intubation-induced hemodynamic response (time frame: From the start of intubation to 3 minutes after the end of intubation). The study lists 2 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 18 Nov 2025.