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Effect of Oliceridine on the Incidence of Hypoxia in Patients Undergoing Hysteroscopic Surgery under Sedation

Effect of Oliceridine on the Incidence of Hypoxia in Patients Undergoing Hysteroscopic Surgery under Sedation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090351
Enrollment
Unknown
Registered
2024-09-27
Start date
2024-09-27
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Interventions

Sufentanil group (S group):Sufentanil (0.15 µg/kg) combined with propofol (1.5 mg/kg)

Sponsors

Renji Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing sedated hysteroscopic surgeries; 2. 18-65 years old; 3.American Society of Anesthesiologists (ASA) Physical Status I–II; 4. Estimated surgical time within 30 minutes; 5. Written informed consent and voluntary participation in this study.

Exclusion criteria

Exclusion criteria: 1. Body mass index (BMI) > 35 kg/m^2 or weight > 75 kg; 2. Patients diagnosed with obstractive sleep apnea; 3. Patients with a history of opioid allergy and contraindication; 4. Long-term use of opioids (defined as >15 morphine equivalent units per day for more than 3 days per week, duration more than 1 month within 1 year before the surgery); Use of any analgesic drug within it's 5 half-life periods (or 48 hours, if unknown) before surgery; Long-term use of non-steroidal anti-inflammatory drugs (daily use for more 2 weeks in the 6 months before surgery, except aspirin =30 days; 6. Severe respiratory insufficiency; 7. Patients with subclinical respiratory depression before surgery; 8. Abnormal electrocardiogram result (QTcF interval > 470 ms at screening time), or abnormal liver or kidney function; 9. Inability to cooperate with the study for any reason, such as: language understanding, mental illness, inability to visit the research center, etc; 10. The investigator considers it inappropriate for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxia in sedated hysteroscopy (75% <=SpO2 < 90%, <60 s);

Secondary

MeasureTime frame
Incidence of subclinical respiratory depression in sedated hysteroscopy (90%60 s);Blood pressure and heart rate 5 minutes after induction of anesthesia;Patient's body movement times and propofol supplemental dose during hysteroscopy;Pain score in the PACU immediately after surgery;Whether hypoxia, subclinical respiratory depression, and severe hypoxia occurred in the PACU;Arterial blood gas analysis in the PACU;The incidences of nausea and vomiting were observed in the PACU;Patient satisfaction with anesthesia experience;surgeon satisfaction with anesthesia experience;Whether airway opening is used;

Countries

China

Contacts

Public ContactSong Zhang

Renji Hospital, Shanghai Jiao Tong University School of Medicine

zhangsong1031@163.com+86 151 5001 2530

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 29, 2026