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A prospective, multi-center, randomized, double-blind, parallel-controlled clinical study on the effectiveness and safety of esketamine and nalbuphine for painless upper gastrointestinal endoscopic anesthesia in children

A prospective, multi-center, randomized, double-blind, parallel-controlled clinical study on the effectiveness and safety of esketamine and nalbuphine for painless upper gastrointestinal endoscopic anesthesia in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040500
Enrollment
Unknown
Registered
2020-12-01
Start date
2020-12-18
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

Digestive tract disease

Interventions

Esketamine group:Before painless gastroscopy, give esketamine and propofol
Nalbuphine group:Before painless gastroscopy, give nalbuphine and propofol

Sponsors

Shanghai Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1. Aged 3~8 years old; 2. Due to dyspepsia, gastric ulcer, or other diseases (such as varicose veins, ingestion of foreign bodies and corrosive esophagitis, etc.) need to undergo upper gastrointestinal endoscopy; 3. ASA score I or II.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to general anesthesia; 2. Children with a history of abnormal recovery after anesthesia; 3. Patients who are tolerant or allergic to esketamine hydrochloride, propofol, and nalbuphine; 4. have used anesthesia within 24 hours Patients who have taken analgesics or have used anesthetics within 5 days, who have taken analgesics, sedatives or anticonvulsants for a long time (continuously or intermittently); 5. Children who are given medication before anesthesia; 6. Pre-existing Abnormal coagulation function, bleeding tendency (such as active peptic ulcer) or undergoing thrombolytic or anticoagulant therapy, anemia or thrombocytopenia; 7. Abnormal liver and kidney function or history of liver or kidney disease; 8. Researchers consider it inappropriate for patients to participate; 9. The child or parents refuse to take part in.

Design outcomes

Primary

MeasureTime frame
drug dose;

Countries

China

Contacts

Public ContactYing Sun

Department of Anesthesiology, Shanghai Children's Medical Center

yingsun821@163.com+86 13621738118

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026