Out-patient Discharge Management After General Intravenou... | NCT05609383

Studies
Out-patient Discharge Management After General Intravenous Anesthesia

NCT05609383

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Withdrawn

Last Update Posted

Mar 15, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Evaluation
Outpatient Surgery

Interventions

assessment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The factors influencing the results of the study have changed

Expanded Access Info

Start Date

Oct 20, 2022Actual

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Oct 18, 2022

First Submission Date that Met QC Criteria

Nov 1, 2022

First Posted Date

Nov 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2023

Last Update Posted Date

Mar 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The lower limit of time for postoperative observation and discharge criteria for diagnostic or operational tests program in outpatient under general intervenous anesthesia/sedation

Detailed Description

When is it considered safe for an outpatient to leave after a advanced procedure of general anesthesia/sedation

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
assessment	Other	An exit evaluation was initiated immediately upon recovery from anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time of discharge	From the time the patient enters the resuscitation room at the end of the session until the patient leaves the resuscitation room	mo more than 60 mintues

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	Adverse reactions (Nausea, vomiting, pain, bleeding, fatigue, dizziness, or readmission for any related reason )	24 hours after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients aged from 18 years with American Society of Anesthesiologists (ASA) physical status I to II were selected. The adaptation and contraindications of the Chinese expert consensus on sedation/anesthesia in digestive endoscopy will be used

Exclusion Criteria:

The inclusion criteria were the patient underwent general anesthesia with endotracheal intubation or patients with systemic comorbidities or unable to walk independently or those who suffered from severe adverse events that required in-hospital observation after diagnosis and treatment or the patients with no available assistance after discharge or the emergency endoscopy patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients undergoing digestive endoscopy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
LIANGYU FANG	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Outpatient Department of the Second Affiliated Hospital of Zhejiang University School of Medicine		Hangzhou	Zhejiang	310009	China

Intervention Browse Module

MeSH Terms

ID	Term
D012149	Restraint, Physical

Ancestor Terms

ID	Term
D032763	Behavior Control
D013812	Therapeutics
D007103	Immobilization
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided