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CompletedNCT07871500Updated Oct 13, 2026

Oliceridine Versus Sufentanil for Blood Pressure Control During Anesthesia Induction in Older Women With Hypertension Undergoing Gynecological Laparoscopic Surgery

A Phase 4 interventional study of Oliceridine and Sufentanil in Hypotension and Hypertension, sponsored by Xingguo Xu. Completed at 1 site in China. Open to female participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Xingguo Xu · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2026, registered Oct 2026).
Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Hypotension
  • Hypertension

Keywords

  • Oliceridine
  • Sufentanil
  • Anesthesia Induction
  • Gynecological Laparoscopic Surgery
  • Hemodynamic
  • Older Adults
03

In context

Hypotension

1,021 studies on the registry are indexed under Hypotension; 172 are open to participants now.

This study's enrollment of 134 is above the median of 80 across 686 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

This is the only study on the registry with Xingguo Xu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
134 participants (actual)

Study arms

  • Experimental
    Oliceridine Group

    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.

    Drug: Oliceridine

  • Active comparator
    Sufentanil Group

    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.

    Drug: Sufentanil

Interventions

  • Intravenous oliceridine 0.10 mg/kg administered during anesthesia induction.

  • Intravenous sufentanil 0.50 micrograms/kg administered during anesthesia induction.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From one minute after anesthesia induction through five minutes after tracheal intubation.

Secondary outcomes

  1. 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.

    Time frame: From one minute after anesthesia induction through five minutes after tracheal intubation

  2. 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.

    Time frame: From one minute after anesthesia induction through five minutes after tracheal intubation.

  3. 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.

    Time frame: Baseline before induction; one minute after induction; immediately after intubation; one and five minutes after intubation.

  4. 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.

    Time frame: Baseline before induction through five minutes after tracheal intubation.

  5. 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.

    Time frame: Baseline before induction through five minutes after tracheal intubation.

  6. 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.

    Time frame: From initiation of anesthesia induction through five minutes after tracheal intubation.

07

Study locations

1 site
  • Affiliated Hospital of Nantong University
    Nantong, Jiangsu 226001, China
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2026 to primary completion in Sep 2026, 4 months.

Of 69 non-industry phase 4 interventional studies under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's 4 months is below that.

Counting every sponsor, half of 76 studies reached it within 12 months; a quarter within 5 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2026
First posted
Oct 13, 2026
StartActual
May 15, 2026
Primary completionActual
Sep 15, 2026
CompletionActual
Sep 15, 2026
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07871500
Lead sponsor
Xingguo Xu
Collaborators
Affiliated Hospital of Nantong University
Responsible party
Xingguo Xu (Chief Physician, Affiliated Hospital of Nantong University) — Sponsor-investigator
First posted
Oct 13, 2026
Start date
May 15, 2026
Primary completion
Sep 15, 2026
Completion
Sep 15, 2026
Last update
Oct 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Oliceridine

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