Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT05908318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Olfactory Training on Postoperative Delirium in the Elderly Undergoing Orthopedic Surgeries
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Study Overview
Official Title:
Preoperative Olfactory Training Reduces the Incidence of Postoperative Delirium in Elderly Patients Undergoingorthopedic Surgeries: a Prospective Randomized Controlled Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To observe whether preoperative olfactory training can reduces the incidence of postoperative delirium in elderly patients undergoing orthopedic surgeries, a prospective randomized controlled study method will be used in this study.
Detailed Description:
450 elderly patients undergoing orthopedic surgeries (hip or knee replacement and laminectomy) under general anesthesia or combined spinal epidural anesthesia will be selected. They will be randomly divided into control group and olfactory training group.The olfactory training group was performed 24-48h before surgery used phenylethyl alcohol (rose), phytol (press tree), citronella (lemon), eugenol (clove) 4 kinds of smell，twice a day for three days. The general condition, operation, anesthesia and hospitalization related data of the patients will be recorded.
Outcome Measures： Incidence of postoperative delirium: The 3D-CAM scores of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Degree of delirium：The MDAS of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Pain：The VAS of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Olfactory function：The TDI scores of the control group and the olfactory training group were evaluated in 3 days before operation and 48h after operation.
Cognitive function：The MoCA scores of the control group and the olfactory training group were evaluated in postoperative 5-7 days.
Markers: Delirium related markers and inflammatory factors in bloods was detected before surgery and after anesthesia. Delirium related markers and inflammatory factors in cerebrospinal fluid was detected after spinal puncture.
Subgroup analysis: patients were divided into delirium group and non-delirium group according to whether delirium occurred, and the data of the two groups were compared, including preoperative and postoperative olfactory function TDI scores, preoperative and postoperative VAS scores, nutritional scores, activity scores, and frailty index, Carlson comorbidity index, depression, anxiety state, sleep disturbance, etc., to screen risk factors.
Outcome Measures： Incidence of postoperative delirium: The 3D-CAM scores of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Degree of delirium：The MDAS of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Pain：The VAS of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Olfactory function：The TDI scores of the control group and the olfactory training group were evaluated in 3 days before operation and 48h after operation.
Cognitive function：The MoCA scores of the control group and the olfactory training group were evaluated in postoperative 5-7 days.
Markers: Delirium related markers and inflammatory factors in bloods was detected before surgery and after anesthesia. Delirium related markers and inflammatory factors in cerebrospinal fluid was detected after spinal puncture.
Subgroup analysis: patients were divided into delirium group and non-delirium group according to whether delirium occurred, and the data of the two groups were compared, including preoperative and postoperative olfactory function TDI scores, preoperative and postoperative VAS scores, nutritional scores, activity scores, and frailty index, Carlson comorbidity index, depression, anxiety state, sleep disturbance, etc., to screen risk factors.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: