Gynecological Laparoscopic Surgery, General Anesthetic, Intubation
Conditions
Brief summary
to investigate whether oliceridine is safe and effective for induction of anesthesia by comparing henodynamic changes before and after endotracheal intubation with sufentanil
Interventions
DRUGOliceridine
Oliceridine is diluted to a 1mg/kg injection solution
DRUGSufentanil
sufentanil is diluted to a 5μg/ml 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 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 years; 2. American Society of Anesthesiologists (ASA) physical status I-II; 3. Elective gynecologic laparoscopic surgery; 4. Expected operative time 60-180 minutes;
Exclusion criteria
1. Severe cardiovascular instability (e.g., acute decompensated heart failure, acute myocardial infarction, or life-threatening arrhythmia); 2. Uncontrolled hypertension; 3. Severe renal or hepatic dysfunction; 4. Severe mental disorder or psychiatric illness; 5. Known allergy or hypersensitivity to opioids; 6. History of alcohol abuse or opioid addiction; 7. Anticipated difficult airway; 8. Pregnancy or lactation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood pressure | baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation |
| heart beat | baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation |
Secondary
| Measure | Time frame |
|---|---|
| adverse reactions | from the administration of sufentanil or oliceridine until discharge from the post-anesthesia care unit (PACU) |
Countries
China
Outcome results
None listed