N/A
Completed N=950
Effect of Anesthesia on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
Post Operative Delirium
Source: ClinicalTrials.gov NCT02213380 ↗
Enrolled (actual)
950
Serious AEs
0.5%
Results posted
Jan 2021
Primary outcomePrimary: Number of Participants With Post-operative Delirium in 7 Days Post Operation — 29; 24 Participants
Summary
The purpose of this study is evaluate postoperative delirium after general anesthesia and regional anesthesia in elderly patients undergoing hip fracture surgery. Our research hypotheses are: (1) regional anesthesia may contribute to decrease the incidence of postoperative delirium. (2) Regional anesthesia may improve the outcome of elderly patient and reduce healthcare costs associated with postoperative delirium. (3) Postoperative delirium may result in poor long-term functional outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Post-operative Delirium in 7 Days Post Operation |
29; 24 | — |
| SECONDARY Number of Participants With Post-operative Delirium |
16; 10; 5; 10; 8; 4 | — |
| SECONDARY Severity of Delirium |
23.48; 24.22 | — |
| SECONDARY The Subtypes of Delirium Diagnosed in 7 Days Post Operation |
16; 16; 2; 1; 2; 3 | — |
| SECONDARY 30 Day Mortality |
8; 4 | — |
| SECONDARY Acute Pain Score Using Visual Analogue Scale (VAS) |
0; 0 | — |
| SECONDARY Length of Hospital Stay |
7; 7 | — |
| SECONDARY Costs of Anesthetic Procedure |
159; 268 | — |
| SECONDARY Total In-hospital Costs |
5582; 5908 | — |
| SECONDARY 6 Months Incidence of Delirium |
— | — |
| SECONDARY 12 Months Incidence of Delirium |
— | — |
| SECONDARY 6 Months Quality of Life |
— | — |
| SECONDARY 12 Months Quality of Life |
— | — |
Eligibility Criteria
Inclusion Criteria
- older patient (≥65 years)
- patient with hip fracture and planned hip fracture surgery
- patient willing to complete this study.
Exclusion Criteria
- patient with multiple trauma or multiple fractures, pathological fractures, pelvic fractures, femur fractures
- contraindication (serious illness or medical conditions) for general anesthesia
- contraindication (infection at the site of needle insertion, coagulopathy, international normalized ratio >1.4, platelet count <80×109 litre-1, allergy to local anaesthetics and so on) for regional anesthesia;
- patient who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial
- patient known to susceptible to malignant hyperthermia
- known allergy or hypersensitivity to any drugs administered during this clinical trial
- previous participation in this clinical trial
- participation in another clinical trial within 4 weeks prior to selection
Data sourced from ClinicalTrials.gov (NCT02213380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.