Drug optimization of postoperative analgesia pump (PCIA) for craniotomy surgery: a study on the efficacy and safety of hydromorphone compared to sufentanil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600132000

Enrollment

Unknown

Registered

2026-09-08

Start date

2026-09-11

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Craniotomy

Interventions

sufentanil group:None

Hydromorphine group:None

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18-65 years old, gender not limited; 2. Planned elective craniotomy for tumor resection surgery; 3. ASA classification II-III; 4. No cognitive impairment before surgery; 5. Voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergies to hydromorphone, any opioid drugs, and dexmedetomidine; 2. Severe liver and kidney dysfunction (Child Pugh C grade, or eGFR3 months) or recent history of drug abuse; 5. Communication barriers prevent completion of pain assessment; 6. Pregnant or lactating women; Serious cardiovascular diseases (such as grade II or above atrioventricular block); 7. Severe bradycardia (HR<50 beats/minute); 8. Heart function NYHA III-IV level); 9. Second surgery patients.

Design outcomes

Primary

Measure	Time frame
numerical rating scale,NRS;	—

Secondary

Measure	Time frame
Rescue Analgesic Within 48 Hours;Incidence of Adverse Reactions;	—

Countries

China

Contacts

Public ContactLyu Jie

The Affiliated Hospital of Guizhou Medical University

3699928@qq.com+86 851 86773956

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026