The Influence of Sedation for Endoscopy on Cognitive Function

NCT04168294 | Terminated FDA Drug FDA Device

• 1 other identifier: rjyyxhk2017001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophagogastroduodenoscopy; Deep Sedation; Cognition Disorders

Keywords

Esophagogastroduodenoscopy; Deep Sedation; Cognition Disorders; Patient Discharge; Automobile Driving

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• heart rate outcome measure

  5 minutes

• SpO2 outcome measure

  5 minutes

Study Arms (2)

sedation group

Patients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus

Drug: Propofol; Device: endoscopy

control group

patients undergo conventional EGD

Device: endoscopy

Interventions

Propofol DRUG

patients in sedation group will be intravenous injected propofol in bolus

sedation group

endoscopy DEVICE

endoscopy system

Also known as: Olympus Lucera Elite 290 system

control group; sedation group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• The scores of MMSE are more than 26.
• The AHA grade I and II.

You may not qualify if:

• The AHA grade III, IV or V.
• binge drinking.
• Take sedatives, sleeping agents and some drug which may affect the study in a month.
• Psychiatric disorders.
• The dysfunction of heart, lung, liver and kidney.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Cognition Disorders

Interventions

Propofol; Endoscopy

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Wei-Ping Li

  Renji Hospital, School of Medicine,Shanghai Jiao Tong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ren Ji Hospital, School of medicine, Shanghai Jiao Tong University

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: November 19, 2019
• Study Start: November 14, 2019
• Primary Completion: November 14, 2019
• Study Completion: November 14, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

CN (1)