HypotensionPhase 4NCT07871500
Oliceridine Versus Sufentanil for Blood Pressure Control During Anesthesia Induction in Older Women With Hypertension Undergoing Gynecological Laparoscopic Surgery
A Phase 4 study testing Oliceridine and Sufentanil in people with Hypotension and Hypertension, run by Xingguo Xu at 1 site in China.
Trial summary
Blood pressure can fall during the start of general anesthesia, particularly in older patients with high blood pressure. This study compared two medicines, oliceridine and sufentanil, to assess their effects on low blood pressure during anesthesia induction in older women with hypertension undergoing gynecological… Read more about this study
- Who is it for?
- Ages 65 to 80 years, women only
- Conditions the study is for
- Hypotension, Hypertension
- 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
- 134 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 15 Sep 2026
- 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 65 to 80 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Female participants aged 65 to 80 years.
- Body mass index of 18.5 to 30.0 kg/m².
- American Society of Anesthesiologists (ASA) physical status classification II or III.
- Scheduled for elective gynecological laparoscopic surgery under general anesthesia.
- Diagnosed with hypertension before surgery.
- Provided written informed consent to participate.
Who cannot join
- Allergy to the study medications or contraindications to their use.
- Psychiatric or cognitive impairment preventing cooperation with study procedures.
- History of chronic pain, long-term heavy alcohol consumption, or opioid misuse.
- Use of analgesic or sedative medications within 48 hours before surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oliceridine and Sufentanil on Post-Induction Hypotension in Patients Undergoing Gynecological Abdominal Surgery
Blood pressure can fall during the start of general anesthesia, particularly in older patients with high blood pressure. This study compared two medicines, oliceridine and sufentanil, to assess their effects on low blood pressure during anesthesia induction in older women with hypertension undergoing gynecological laparoscopic surgery.
This single-center randomized controlled trial enrolled 134 women aged 65 to 80 years at the Affiliated Hospital of Nantong University. Participants were assigned to receive either oliceridine or sufentanil, together with the same other anesthesia induction medicines. Blood pressure and heart rate were measured before induction, one minute after induction, immediately after insertion of the breathing tube, and one and five minutes after insertion.
The main outcome was the proportion of participants who experienced low blood pressure during these measurements. Low blood pressure was defined as a mean arterial pressure below 65 mmHg or a decrease of at least 30% from the value measured before induction. Other assessments included changes and variability in blood pressure, heart rate, and the use of medicines to support blood pressure.
- Conditions
- Hypotension, Hypertension
- Being tested
- Oliceridine, Sufentanil
- Keywords
- Oliceridine, Sufentanil, Anesthesia Induction, Gynecological Laparoscopic Surgery, Hemodynamic, Older Adults
- Medical subject headings
- Hypotension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
Intravenous oliceridine 0.10 mg/kg administered during anesthesia induction.
SufentanilDrug
Intravenous sufentanil 0.50 micrograms/kg administered during anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine Group | Experimental | Participants received intravenous oliceridine 0.10 mg/kg during anesthesia induction, together with etomidate 0.15 mg/kg, remimazolam 0.20 mg/kg, and vecuronium 0.10 mg/kg. Receives: Drug: Oliceridine |
| Sufentanil Group | Active comparator | Participants received intravenous sufentanil 0.50 micrograms/kg during anesthesia induction, together with etomidate 0.15 mg/kg, remimazolam 0.20 mg/kg, and vecuronium 0.10 mg/kg. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypotension During Anesthesia Induction
Percentage of participants with hypotension at any of the four assessment time points: one minute after anesthesia induction, immediately after tracheal intubation, and one and five minutes after intubation. Hypotension is defined as mean arterial pressure (MAP) below 65 mmHg or a decrease of at least 30% from the pre-induction baseline MAP. Participants meeting either criterion at one or more assessment time points are counted once.
Measured: From one minute after anesthesia induction through five minutes after tracheal intubation.
Secondary outcomes (6)
Minimum Mean Arterial Pressure
Lowest mean arterial pressure (MAP), in mmHg, among measurements obtained one minute after anesthesia induction, immediately after tracheal intubation, and one and five minutes after intubation.
Measured: From one minute after anesthesia induction through five minutes after tracheal intubation
Maximum Percentage Decrease in Mean Arterial Pressure
Maximum percentage decrease in mean arterial pressure (MAP) from the pre-induction baseline across the four post-induction assessment time points. Percentage decrease is calculated as 100 × (baseline MAP - post-induction MAP) / baseline MAP.
Measured: From one minute after anesthesia induction through five minutes after tracheal intubation.
Change in Mean Arterial Pressure From Baseline
Change in mean arterial pressure (MAP), in mmHg, from the pre-induction baseline at each assessment time point. Change is calculated as MAP at the assessment time point minus baseline MAP; negative values indicate a decrease.
Measured: Baseline before induction; one minute after induction; immediately after intubation; one and five minutes after intubation.
Mean Arterial Pressure at Specified Time Points
Mean arterial pressure (MAP), in mmHg, measured before anesthesia induction, one minute after induction, immediately after tracheal intubation, and one and five minutes after intubation.
Measured: Baseline before induction through five minutes after tracheal intubation.
Heart Rate at Specified Time Points
Heart rate, in beats per minute, measured before anesthesia induction, one minute after induction, immediately after tracheal intubation, and one and five minutes after intubation.
Measured: Baseline before induction through five minutes after tracheal intubation.
Percentage of Participants Receiving Vasoactive Medication
Percentage of participants receiving at least one vasoactive medication to support blood pressure during the anesthesia induction observation period. Each participant is counted once regardless of the number of doses administered.
Measured: From initiation of anesthesia induction through five minutes after tracheal intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 May 2026
- Primary completion15 Sep 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This single-center randomized controlled trial assigned 134 participants in a 1:1 ratio to receive either oliceridine or sufentanil during anesthesia induction, with 67 participants in each group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xingguo Xu
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Nantong University
- Responsible party
- Sponsor-investigator, Xingguo Xu, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871500
- Sponsor's protocol ID
- 2024-K034
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on sharing individual participant data has not yet been made. The study team will review participant consent and institutional requirements before determining whether and how de-identified data can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oliceridine and Sufentanil on Post-Induction Hypotension in Patients Undergoing Gynecological Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07871500
- Acronym / sponsor ID
- 2024-K034
- Conditions
- Hypotension, Hypertension
- Keywords
- Oliceridine, Sufentanil, Anesthesia Induction, Gynecological Laparoscopic Surgery, Hemodynamic, Older Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Xingguo XuUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Nantong University
- Study start
- 15 May 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 13 Oct 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.
Blood pressure can fall during the start of general anesthesia, particularly in older patients with high blood pressure. This study compared two medicines, oliceridine and sufentanil, to assess their effects on low blood pressure during anesthesia induction in older women with hypertension undergoing gynecological laparoscopic surgery.
This single-center randomized controlled trial enrolled 134 women aged 65 to 80 years at the Affiliated Hospital of Nantong University. Participants were assigned to receive either oliceridine or sufentanil, together with the same other anesthesia induction medicines. Blood pressure and heart rate were measured before induction, one minute after induction, immediately after insertion of the breathing tube, and one and five minutes after insertion.
The main outcome was the proportion of participants who experienced low blood pressure during these measurements. Low blood pressure was defined as a mean arterial pressure below 65 mmHg or a decrease of at least 30% from the value measured before induction. Other assessments included changes and variability in blood pressure, heart rate, and the use of medicines to support blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This single-center randomized controlled trial assigned 134 participants in a 1:1 ratio to receive either oliceridine or sufentanil during anesthesia induction, with 67 participants in each group.
| Arm | Type | Receives |
|---|---|---|
| Oliceridine Group | Experimental | Drug: OliceridineParticipants received intravenous oliceridine 0.10 mg/kg during anesthesia induction, together with etomidate 0.15 mg/kg, remimazolam 0.20 mg/kg, and vecuronium 0.10 mg/kg. |
| Sufentanil Group | Active comparator | Drug: SufentanilParticipants received intravenous sufentanil 0.50 micrograms/kg during anesthesia induction, together with etomidate 0.15 mg/kg, remimazolam 0.20 mg/kg, and vecuronium 0.10 mg/kg. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Female participants aged 65 to 80 years.
- Body mass index of 18.5 to 30.0 kg/m².
- American Society of Anesthesiologists (ASA) physical status classification II or III.
- Scheduled for elective gynecological laparoscopic surgery under general anesthesia.
- Diagnosed with hypertension before surgery.
Key exclusion criteria (4 listed)
- Allergy to the study medications or contraindications to their use.
- Psychiatric or cognitive impairment preventing cooperation with study procedures.
- History of chronic pain, long-term heavy alcohol consumption, or opioid misuse.
- Use of analgesic or sedative medications within 48 hours before 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 |
|---|---|---|
| OliceridineIntravenous oliceridine 0.10 mg/kg administered during anesthesia induction. | Drug | Oliceridine Group |
| SufentanilIntravenous sufentanil 0.50 micrograms/kg administered during anesthesia induction. | Drug | Sufentanil Group |
Primary outcome
Incidence of Hypotension During Anesthesia Induction
Time frame: From one minute after anesthesia induction through five minutes after tracheal intubation.
Percentage of participants with hypotension at any of the four assessment time points: one minute after anesthesia induction, immediately after tracheal intubation, and one and five minutes after intubation. Hypotension is defined as mean arterial pressure (MAP) below 65 mmHg or a decrease of at least 30% from the pre-induction baseline MAP. Participants meeting either criterion at one or more assessment time points are counted once.
6 secondary outcomes
Minimum Mean Arterial Pressure
Time frame: From one minute after anesthesia induction through five minutes after tracheal intubation
Maximum Percentage Decrease in Mean Arterial Pressure
Time frame: From one minute after anesthesia induction through five minutes after tracheal intubation.
Change in Mean Arterial Pressure From Baseline
Time frame: Baseline before induction; one minute after induction; immediately after intubation; one and five minutes after intubation.
Mean Arterial Pressure at Specified Time Points
Time frame: Baseline before induction through five minutes after tracheal intubation.
Heart Rate at Specified Time Points
Time frame: Baseline before induction through five minutes after tracheal intubation.
Percentage of Participants Receiving Vasoactive Medication
Time frame: From initiation of anesthesia induction through five minutes after tracheal 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 13 Oct 2026.
- Individual participant dataSharing planned: Undecided. A decision on sharing individual participant data has not yet been made. The study team will review participant consent and institutional requirements before determining whether and how de-identified data can be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oliceridine and Sufentanil in people with Hypotension and Hypertension, run by Xingguo Xu 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 6 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 13 Oct 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.
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?
Incidence of Hypotension During Anesthesia Induction (time frame: From one minute after anesthesia induction through five minutes after tracheal intubation.). 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 13 Oct 2026.