The Influence of Sedation for Endoscopy on Cognitive Function

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.

Study Overview

• Status: Terminated
• Conditions: Cognition Disorders; Esophagogastroduodenoscopy; Deep Sedation
• Intervention / Treatment: Drug: Propofol; Device: endoscopy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Radom select patients who undergo EGD in Renji Hospital, School of Medicine, Shanghai Jiaotong University. Patients who are recruited all received nine year compulsory education and fit for the inclusion criteria. Moreover, all patients received approval from the local institutional review board.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
sedation group; Patients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus	Drug: Propofol; patients in sedation group will be intravenous injected propofol in bolus; Device: endoscopy; endoscopy system; Other Names: Olympus Lucera Elite 290 system
control group; patients undergo conventional EGD	Device: endoscopy; endoscopy system; Other Names: Olympus Lucera Elite 290 system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NCT-A test outcome measure	the score of NCT-A test for each patient is not less than that in the baseline.	30 minutes
DST test outcome measure	the score of DST for each patient is not less than that in the baseline.	30 minutes
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate outcome measure	heart rate less than 50 time per minute	5 minutes
SpO2 outcome measure	SpO2 less than 90%	5 minutes

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: Wei-Ping Li, Renji Hospital, School of Medicine,Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Actual): November 14, 2019
• Study Completion (Actual): November 14, 2019

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: November 16, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 16, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Cognition Disorders; Esophagogastroduodenoscopy; Deep Sedation; Patient Discharge; Automobile Driving
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: rjyyxhk2017001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No