The Influence of Sedation for Endoscopy on Cognitive Function

Cognition Disorders Clinical Trial

Official title:

The Influence of Sedation for Endoscopy on Cognitive Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04168294
• Other study ID #: rjyyxhk2017001
• Status: Terminated
• Start date: November 14, 2019
• Est. completion date: November 14, 2019

Study information

• Verified date: November 2019
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It is commonly recommended that patients should refrain from driving for 24 hours after sedation for endoscopy，however，this recommendation has been queried recently．To investigate the effect of sedation on early postoperative cognitive function in patients undergoing endoscopy.

Description:

One hundred adult patients undergoing sedative esophagogastroduodenoscopy ( EGD) were randomly recruited，and another 100 adult patients undergoing conventional（without sedation） EGD were served as controls． All patients had an education level more than 9 years． Cognitive function was assessed by Montreal Cognitive Assessment（MoCA）1 week before EGD exam, 10 mins before propofol sedation or the beginning of endoscopic procedure, 30mins after EGD exam, and 2 week after exam.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: November 14, 2019
• Est. primary completion date: November 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

1. The scores of MMSE are more than 26.

2. The AHA grade I and II.

Exclusion Criteria:

1. The AHA grade III, IV or V.

2. binge drinking.

3. Take sedatives, sleeping agents and some drug which may affect the study in a month.

4. Psychiatric disorders.

5. The dysfunction of heart, lung, liver and kidney.

Related Conditions & MeSH terms

• Cognition Disorders
• Deep Sedation
• Esophagogastroduodenoscopy

Intervention

Drug:
• Propofol
patients in sedation group will be intravenous injected propofol in bolus

Device:
• endoscopy
endoscopy system

Locations

Country	Name	City	State
China	Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NCT-A test outcome measure	the score of NCT-A test for each patient is not less than that in the baseline.	30 minutes
Primary	DST test outcome measure	the score of DST for each patient is not less than that in the baseline.	30 minutes
Primary	number cancellation test outcome measure	the score of number cancellation test for each patient is not less than that in the baseline.	30 minutes
Secondary	heart rate outcome measure	heart rate less than 50 time per minute	5 minutes
Secondary	SpO2 outcome measure	SpO2 less than 90%	5 minutes