- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609383
Out-patient Discharge Management After General Intravenous Anesthesia
March 13, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
The lower limit of time for postoperative observation and discharge criteria for diagnostic or operational tests program in outpatient under general intervenous anesthesia/sedation
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
When is it considered safe for an outpatient to leave after a advanced procedure of general anesthesia/sedation
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Outpatient Department of the Second Affiliated Hospital of Zhejiang University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients undergoing digestive endoscopy
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time of discharge
Time Frame: mo more than 60 mintues
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events
Time Frame: 24 hours after surgery
|
Adverse reactions (Nausea, vomiting, pain, bleeding, fatigue, dizziness, or readmission for any related reason )
|
24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: LIANGYU FANG, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2022
Primary Completion (Anticipated)
June 30, 2023
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
October 18, 2022
First Submitted That Met QC Criteria
November 1, 2022
First Posted (Actual)
November 8, 2022
Study Record Updates
Last Update Posted (Actual)
March 15, 2023
Last Update Submitted That Met QC Criteria
March 13, 2023
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2021-0125
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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