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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
450
In this group, patients were 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.
Incidence of postoperative delirium
The 3D-CAM scores
Time frame: Postoperative 1-5 days
Degree of delirium
Memorial delirium assessment scale(MDSA)
Time frame: Postoperative 1-5 days
Olfactory function
The Sniffin' Sticks test involves testing odor for threshold and discrimination whilst blind folded and secondly odor identification. The sum of four odors responses ranges from 0-16. The sum of total score from odor Threshold, Discrimination and Identification (TDI) is a maximum of 48 points. The total score is graded as; normosmia equals or over 30.5 points, hyposmia 16.5-30 points and anosmia less than 16.5 points.
Time frame: postoperative 48h compared to preoperative 72h
Cognitive function
Total score of the Montreal Cognitive Assessment (MoCA).
Time frame: postoperative 5-7 days
Postoperative pain
Post-operative pain, measured in visual analogue scale (VAS),0:no pian, 10:worst pain.
Time frame: Postoperative 1-5 days
Delirium related markers and inflammatory factors in bloods
These markers include:IL-6, IL-8, IL-10, TNF-α, IL-1β, CRP, N-terminal BNP, albumin, NSE, S-100B, Aβ-42 and T-tau, P-tau, S-100β
Time frame: immediate post-anesthesia compared to pre-operation
Delirium related markers and inflammatory factors in cerebrospinal fluid
These markers include:IL-6, IL-8, IL-10, TNF-α, IL-1β, albumin, NSE, S-100B, Aβ-42 and T-tau, P-tau, S-100β
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Time frame: immediate post-anesthesia compared to pre-operation