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The Effect and Safety of Alfentanil on Postoperative Vomiting in Children Aged 1-3 Years Undergoing Laparoscopic Herniorrhaphy:a randomized clinical trial

The Effect and Safety of Alfentanil on Postoperative Vomiting in Children Aged 1-3 Years Undergoing Laparoscopic Herniorrhaphy:a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116894
Enrollment
Unknown
Registered
2026-01-16
Start date
2026-01-20
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Laparoscopic high ligation of the inguinal hernia sac was performed, and postoperative vomiting occurred

Interventions

The afentanil group:Afentanil Hydrochloride Injection

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 3 Years

Inclusion criteria

Inclusion criteria: 1.Age 1 to 3 years old, gender not limited, ASA grade I to II; 2.Laparoscopic high ligation of the hernia sac will be performed at an elective date; 3.If the operation time is within 60 minutes, intravenous anesthesia is suitable during both the induction and maintenance of general anesthesia; 4.The legal guardian signs the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Cardiovascular system diseases: severe congenital heart disease (tetralogy of Fallot, etc.), severe arrhythmias (bradycardia/tachycardia requiring drug treatment, third-degree atrioventricular block), severe heart failure, etc; 2.Respiratory system diseases: Respiratory insufficiency, a history of bronchial spasm/asthma requiring treatment within one month before the screening period, acute upper respiratory tract infection within one week before the screening period with one of the following symptoms: obvious fever, wheezing or cough; 3.Gastrointestinal diseases: Gastrointestinal retention, active bleeding, and conditions that may lead to reflux and aspiration; 4.Central nervous system diseases: Patients with a history of craniocerebral injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysms, and cerebral vascular accidents; Or there is a known history of mental disorders (schizophrenia, mania, long-term use of psychotropic drugs, cognitive dysfunction, etc.); Those with known abnormal electroencephalograms; 5.Uncontrolled history of significant clinical diseases of the liver, kidneys, blood system, nervous system or metabolic system, etc; 6.Others: Developmental delay, obesity, diabetes, congenital conduction disorders, PONV history/family history, motion sickness; 7.Opioid allergy or contraindications to anesthesia; 8.Psychotropic drugs, antiemetic drugs or glucocorticoids were used 24 hours before the operation; 9.Pediatric populations that require special care or supervision by courts or social welfare institutions;

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative vomiting;

Secondary

MeasureTime frame
Perioperative vital signs;The incidence of postoperative irritability;The time for removing the tracheal tube;Eye-opening time;Pain Score (FLACC score);

Countries

China

Contacts

Public ContactXu Ying

Children's Hospital of Chongqing Medical University

xuyingxy3066@126.com+86 23 68576050

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026