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Completed

NCT Number: NCT07713134

Comparison of the Efficacy and Safety of Oliceridine and Sufentanil in Patients Undergoing Outpatient Hysteroscopy

This study aimed to investigate the safety and efficacy of oliceridine compared with sufentanil in outpatient hysteroscopy.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tangshan Maternal and Child Health Hospital, Tangshan, Hebei 063000

Tangshan, Hebei, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • voluntary signing of the anesthesia informed consent form;
  • stable vital signs;
  • age between 18 and 60years;
  • American Society of Anesthesiologists (ASA) physical status I or II; and
  • body mass index (BMI) <30 kg/m²

Exclusion criteria

  • inability or unwillingness to sign the informed consent form;
  • known allergy to the study drug;
  • uncontrolled hypertension or diabetes mellitus;
  • significant central nervous system disease;
  • diagnosed psychiatric disorders;
  • use of anxiolytics, antidepressants, hypnotics, or sedatives within the past three months

Treatment and study plan

Sufentanil

Drug

sufentanil is diluted to a 5μg/ml injection solution

Oliceridine

Drug

Oliceridine is diluted to a 1mg/kg injection solution

Primary outcomes

  1. heart rate(beats per minute)

    Time frame: before anesthesia induction (baseline), immediately after induction of anesthesia, and at the end of surgery

  2. mean arterial pressure(mmHg)

    Time frame: before anesthesia induction (baseline), immediately after induction of anesthesia, and at the end of surgery

  3. proportion of participants with successful completion of office hysteroscopy procedure

    Time frame: at the end of the hysteroscopy procedure

Secondary outcomes

  1. number of participants with postoperative nausea and vomiting within 24 hours after surgery

    Time frame: within 24 hours after surgery

  2. number of Participants with Intraoperative Respiratory Depression

    Time frame: from induction of anesthesia to completion of surgery

Sponsors and collaborators

Lead sponsor

Tangshan Maternal and Child Health Hospital

Other

Registry information

Official study title

Efficacy and Safety of the Biased μ-Opioid Receptor Agonist Oliceridine in Hysteroscopic Procedures

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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