Olfactory Function and Postoperative Cognitive Dysfunction

Not Applicable

Completed

• Conditions: Postoperative Cognitive Dysfunction
• Interventions: Behavioral: enhanced olfactory stimuli

• Registration Number: NCT03441074
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-22
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	enhanced olfactory stimuli	Patients randomly assigned to intervention group will get enhanced olfactory stimuli during the perioperative period

Primary Outcome Measures

Name	Time	Method
Change of cognitive function	1 day before surgery (baseline) and 7 days after surgery (follow-up)	The neuropsychological tests to assess change of cognitive function between baseline and follow-up

Secondary Outcome Measures

Name	Time	Method
Change of olfactory function	1 day before surgery (baseline) and 7 days after surgery (follow-up)	The olfactory tests to assess change of olfactory function between baseline and follow-up

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China