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The effect of oliceridine on postoperative nausea and vomiting in PONV high-risk patients undergoing general anesthesia surgery: a study protocol for a prospective, double-blind, randomized controlled clinical study

The effect of oliceridine on postoperative nausea and vomiting in PONV high-risk patients undergoing general anesthesia surgery: a study protocol for a prospective, double-blind, randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089121
Enrollment
Unknown
Registered
2024-09-02
Start date
2024-09-10
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative nausea and vomiting

Interventions

Oliceridine group:Anesthetic drugs using oliceridine
Fentanyl group:Anesthetic drugs using fentanyl

Sponsors

Dongtai People's Hospital, Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: A simplified adult PONV risk score of =3 points is used for female patients undergoing elective laparoscopic cholecystectomy, laparoscopic uterine and ovarian surgery under general anesthesia; ASA classification I-III level; BMI is 18.5-29.9kg/m2; Obtain informed consent from patients.

Exclusion criteria

Exclusion criteria: History of surgery under general anesthesia within one month prior to surgery; Preoperative severe cardio pulmonary cerebral system diseases, such as severe hypertension (crisis), severe diabetes (ketosis, acidosis), coronary heart disease, COPD, Asthma, respiratory failure, pulmonary arterial hypertension, severe arrhythmia (atrial fibrillation, atrioventricular block at or above II degree, sick sinus syndrome, etc.), severe heart valve disease, heart failure, renal failure, Stroke and myocardial infarction within 6 months, Alzheimer's disease, Parkinson's disease, mental illness, OSS, myasthenia gravis, etc; History of chronic pain; Patients with liver and kidney dysfunction and leukopenia; Individuals with a history of allergies to drugs used in the study; Patients with a history of inflammatory bowel disease or peptic ulcer; those with abnormal coagulation function; METS<4; Tumor patients undergoing radiotherapy and chemotherapy; The patient refusal or inability to cooperate in participating in this study; Patients who participate in other studies within 30 days.

Design outcomes

Primary

MeasureTime frame
The incidence of nausea and vomiting in patients 48 hours after surgery;

Secondary

MeasureTime frame
Patient postoperative nausea and vomiting severity score (VAS) and salvage rate at 48 hours;Postoperative NSAIDs medication rescue frequency and total rescue dosage;VAS scores for resting pain and exercise pain at 24h, 48h after surgery and before discharge;Complications during surgery and anesthesia recovery period;

Countries

China

Contacts

Public ContactJiangfeng Zhao

Dongtai People's Hospital, Jiangsu Province

dtrmyymzk@163.com+86 136 0142 8066

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 15, 2026