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Effects and Safety of Oliceridine in Anesthesia Induction:A Randomised Controlled Trial

T

Tangshan Maternal and Child Health Hospital

Status

Completed

Conditions

Gynecological Laparoscopic Surgery
General Anesthetic
Intubation

Treatments

Drug: Sufentanil
Drug: Oliceridine

Study type

Interventional

Funder types

Other

Identifiers

NCT07372209
2024-074-01

Details and patient eligibility

About

to investigate whether oliceridine is safe and effective for induction of anesthesia by comparing henodynamic changes before and after endotracheal intubation with sufentanil

Enrollment

120 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups

sufentanil
Active Comparator group
Description:
0.5μg/kg of sufentanil was used for anesthesia induction
Treatment:
Drug: Sufentanil
Oliceridine
Experimental group
Description:
0.13mg/kg oliceridine was used for anesthesia induction
Treatment:
Drug: Oliceridine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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