NCT02940236

Brief Summary

To assess possible risk of aspiration with pre-operative oral medications taken with "sips" of water (100ml).

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 2016

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withdrawn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

Study Start

First participant enrolled

October 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

October 19, 2016

Last Update Submit

March 22, 2023

Conditions

General Surgery

Outcome Measures

Primary Outcomes (1)

  • Oral multimodal analgesia and gastric volume

    Baseline

Study Arms (1)

Multimodal analgesia

Patients scheduled for general surgery and requiring multimodal analgesia in preoperative period.

Other: Ultrasound

Interventions

UltrasoundOTHER

Before and after patient receives oral multimodal analgesia as per standard of care, two ultrasound scans will be performed (10 minutes apart for each time element).

Multimodal analgesia

Eligibility Criteria

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

All adult patients scheduled for undergo surgical procedure

You may qualify if:

  • Patients able to take prescribed oral multimodal analgesia as per standard of care

You may not qualify if:

  • BMI \> 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 20, 2016

Study Start

October 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)