Clinical trial NCT03441074: Olfactory Function and Postoperative Cognitive Dysfunction
Official title: Effects of Enriched Olfactory Stimuli on Postoperative Cognitive Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2018-02-22
Enrollment: 131
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the correlation of POCD with olfactory function. To explore whether enhanced olfactory stimuli can reduce the risk of POCD as a preventive strategy.

Detailed description: Postoperative cognitive dysfunction (POCD), the most common complications of geriatric surgical patients, could contribute to long-term social dysfunction, high mortality and increased medical cost. Previous studies have suggested that impaired Olfaction was related to postoperative delirium (Nadya M. Dhanani et al, J Clin Anesth 2012; Charles H. Brown IV et al, J Am Geriatr So 2015; Min Seung Kim et al, J Neural Transm 2016). However, there is still no efficient treatment for POCD, and it also remains largely unknown whether enhanced olfactory stimuli can be used as an inventive strategy to reduce the risk of POCD.

Eligibility criteria: Inclusion Criteria:

1. Keen surgery under general anesthesia;
2. Age is greater than or equal to 65 years old;
3. Han Nationality, mother tongue is chinese;
4. The MMSE score: Illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points;
5. Being able to complete the assessments without serious visual or hearing difficulty;
6. Without serious heart, brain, liver, kidney, lung and other organs;
7. Without serious neurological and psychiatric disorders, such as Alzheimer's disease, Parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.;
8. The ASA class I or II;
9. The people signed informed consent.

Exclusion Criteria:

1. Had severe head and face disease, trauma history or history of surgery;
2. Had a history of influenza in 3 weeks;
3. The serious body disease and tobacco, wine and other substance abuse history;
4. The presence of malignant tumor with shorter survival disease.

Primary outcomes:
measure: Change of cognitive function
timeFrame: 1 day before surgery (baseline) and 7 days after surgery (follow-up)
Secondary outcomes:
measure: Change of olfactory function
timeFrame: 1 day before surgery (baseline) and 7 days after surgery (follow-up)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yuan Shen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim MS, Yoon JH, Kim HJ, Yong SW, Hong JM. Olfactory dysfunction is related to postoperative delirium in Parkinson's disease. J Neural Transm (Vienna). 2016 Jun;123(6):589-94. doi: 10.1007/s00702-016-1555-0. Epub 2016 Apr 20.
citation: Brown CH 4th, Morrissey C, Ono M, Yenokyan G, Selnes OA, Walston J, Max L, LaFlam A, Neufeld K, Gottesman RF, Hogue CW. Impaired olfaction and risk of delirium or cognitive decline after cardiac surgery. J Am Geriatr Soc. 2015 Jan;63(1):16-23. doi: 10.1111/jgs.13198.
citation: Dhanani NM, Jiang Y. Anosmia and hypogeusia as a complication of general anesthesia. J Clin Anesth. 2012 May;24(3):231-3. doi: 10.1016/j.jclinane.2011.08.005. Epub 2012 Apr 9.