Olfactory Function and Postoperative Cognitive Dysfunction

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Effects of Enriched Olfactory Stimuli on Postoperative Cognitive Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03441074
• Other study ID #: dsyy003
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Shanghai 10th People's Hospital
• Contact: Yuan Shen, MD, PhD
• Phone: 2166303649
• Email: kmshy[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Dysfunction

Intervention

Behavioral:
• enhanced olfactory stimuli
Patients in intervention group will get enhanced olfactory stimuli during perioperative period (7 days before and after the surgery), by using portable scented sachets.

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital	Massachusetts General Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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: 10.111 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of cognitive function	The neuropsychological tests to assess change of cognitive function between baseline and follow-up	1 day before surgery (baseline) and 7 days after surgery (follow-up)
Secondary	Change of olfactory function	The olfactory tests to assess change of olfactory function between baseline and follow-up	1 day before surgery (baseline) and 7 days after surgery (follow-up)