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

Tangshan Maternal and Child Health Hospital225 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

225

Conditions

Hysteroscopy Analgeisa

Interventions

SufentanilDRUG

sufentanil is diluted to a 5μg/ml injection solution

OliceridineDRUG

Oliceridine is diluted to a 1mg/kg injection solution

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. voluntary signing of the anesthesia informed consent form; 2. stable vital signs; 3. age between 18 and 60years; 4. American Society of Anesthesiologists (ASA) physical status I or II; and 5. body mass index (BMI) \<30 kg/m² Exclusion Criteria: 1. inability or unwillingness to sign the informed consent form; 2. known allergy to the study drug; 3. uncontrolled hypertension or diabetes mellitus; 4. significant central nervous system disease; 5. diagnosed psychiatric disorders; 6. use of anxiolytics, antidepressants, hypnotics, or sedatives within the past three months

Locations (1)

Tangshan Maternal and Child Health Hospital, Tangshan, Hebei 063000

Tangshan, Hebei, China

Outcomes

Primary Outcomes

heart rate（beats per minute）

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

mean arterial pressure(mmHg)

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

proportion of participants with successful completion of office hysteroscopy procedure

Time frame: at the end of the hysteroscopy procedure

Secondary Outcomes

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

Time frame: within 24 hours after surgery

number of Participants with Intraoperative Respiratory Depression

Time frame: from induction of anesthesia to completion of surgery

Data from ClinicalTrials.gov

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