NCT05609383

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

October 20, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 15, 2023

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

October 18, 2022

Last Update Submit

March 13, 2023

Conditions

EvaluationOutpatient Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Adverse events

    24 hours after surgery

Interventions

assessmentOTHER

An exit evaluation was initiated immediately upon recovery from anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing digestive endoscopy

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Department of the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • LIANGYU FANG

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2022

First Posted

November 8, 2022

Study Start

October 20, 2022

Primary Completion

June 30, 2023

Study Completion

December 30, 2023

Last Updated

March 15, 2023

Record last verified: 2022-10

Locations

CN(1)