Olfactory Function and Postoperative Cognitive Dysfunction

• Sponsor: Shanghai 10th People's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03441074
• Collaborator: Massachusetts General Hospital (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Cognitive Dysfunction	Behavioral: enhanced olfactory stimuli	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Enriched Olfactory Stimuli on Postoperative Cognitive Dysfunction
• Actual Study Start Date: Jan 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Patients randomly assigned to intervention group will get enhanced olfactory stimuli during the perioperative period	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.
No Intervention: Non-intervention Group Patients randomly assigned to non-intervention group will not get any olfactory stimuli during the perioperative period

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Tenth People's Hospital	Shanghai	Shanghai	China	200072

Sponsors and Collaborators

• Shanghai 10th People's Hospital
• Massachusetts General Hospital

Investigators

• Principal Investigator: Yuan Shen, Shanghai 10th People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuan Shen, MD, PhD, Chief of Psychiatry, Shanghai 10th People's Hospital
• ClinicalTrials.gov Identifier: NCT03441074
• Other Study ID Numbers: dsyy003
• First Posted: Feb 22, 2018
• Last Update Posted: Mar 23, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction

Study Results

No Results Posted as of Mar 23, 2021