NCT04093726

Brief Summary

To observe the effect of chewing lollipop on residual gastric volume in healthy volunteers with fasting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2019

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

September 16, 2019

Last Update Submit

April 15, 2020

Conditions

Gastric Volume

Outcome Measures

Primary Outcomes (1)

  • residual gastric volume at 30 minutes after chewing lollipop

    from starting chewing lollipop to 30 minutes after chewing, on an average of 30 minutes

Secondary Outcomes (3)

  • residual gastric volume at 2 hours after chewing lollipop

    from starting chewing lollipop to 2 hours after chewing, on an average of 2 hours

  • residual gastric volume at 1 hour after chewing lollipop

    residual gastric volume at 1 hour after chewing lollipop

  • time to peak gastric volume

    from starting chewing lollipop to gastric volume reaching peak , on an average of 1 hour

Study Arms (2)

lollipop

EXPERIMENTAL
Other: lollipop

control

NO INTERVENTION

Interventions

lollipopOTHER

chewing lollipop for 20min

lollipop

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • volunteer aged 18 years-45 years old
  • volunteer with a body mass index between 18 and 28 kg/m2

You may not qualify if:

  • those with history of diabetes mellitus
  • those with gastric diseases
  • those with history of gastro-intestinal surgery
  • those with history of smoking
  • those with use of gastric mobility medicines
  • those with pregnancy or breeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Schoenfelder RC, Ponnamma CM, Freyle D, Wang SM, Kain ZN. Residual gastric fluid volume and chewing gum before surgery. Anesth Analg. 2006 Feb;102(2):415-7. doi: 10.1213/01.ane.0000189218.07293.6e.

    PMID: 16428535RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 18, 2019

Study Start

October 21, 2019

Primary Completion

December 22, 2019

Study Completion

December 22, 2019

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

CN(1)