Analgeisa, Hysteroscopy
Conditions
Brief summary
This study aimed to investigate the safety and efficacy of oliceridine compared with sufentanil in outpatient hysteroscopy.
Interventions
DRUGSufentanil
sufentanil is diluted to a 5μg/ml injection solution
DRUGOliceridine
Oliceridine is diluted to a 1mg/kg injection solution
Sponsors
Tangshan Maternal and Child Health Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| heart rate（beats per minute） | before anesthesia induction (baseline), immediately after induction of anesthesia, and at the end of surgery |
| mean arterial pressure(mmHg) | 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 | at the end of the hysteroscopy procedure |
Secondary
| Measure | Time frame |
|---|---|
| number of participants with postoperative nausea and vomiting within 24 hours after surgery | within 24 hours after surgery |
| number of Participants with Intraoperative Respiratory Depression | from induction of anesthesia to completion of surgery |
Countries
China
Outcome results
None listed