Clinical trial · Interventional
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
Low-dose Neuroleptanalgesia Reduce the Occurrences of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Major Surgery : a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Postoperative delirium（POD）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Fractures, Bone | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Osteoarthropathy | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low-dose neuroleptanalgesia | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neuroleptanalgesia group
- description
- Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure.
- interventionNames
- Drug: low-dose neuroleptanalgesia
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 65 years old and ≤ 85 years old; 2. Selective non-cardiac major surgery; 3. Informed consent and voluntary participation in the trial; 4. ASA class I-II; 5. Anticipated operation duration ≥ 2 hours; 6. No plan to ICU after operation. Exclusion Criteria: 1. Neurosurgery; 2. Patients with neurological and mental diseases: such as basal ganglia disease, Parkinson's syndrome, severe central nervous depression, Alzheimer's disease , etc; 3. Patients with prolonged Q-T interval, cardiac repolarization disorder and other severe arrhythmia; 4. Patients with severe cardiopulmonary disease, liver and kidney dysfunction; 5. Allergic or contraindications to droperidol or fentanyl citrate; 6. Admitted to ICU after operation. 7. Operation duration \< 2 hours;
References
Publications (0)
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