NCT01809938

Brief Summary

Most pre-operative fasting regimes dictate that if there is any milk added to tea or coffee, the preoperative fasting time should be extended from 2 to 6 hours. The purpose of this study is to demonstrate whether there is really a delay in gastric emptying time associated with the inclusion of milk in a cup of tea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

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

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 30, 2013

Completed
Last Updated

December 18, 2013

Status Verified

November 1, 2013

Enrollment Period

2 months

First QC Date

March 7, 2013

Results QC Date

August 25, 2013

Last Update Submit

November 24, 2013

Conditions

Gastric Emptying

Keywords

Gastrointestinal tract emptyingPre-operative fastingUltrasoundParacetamol Absorption

Outcome Measures

Primary Outcomes (1)

  • Tmax

    tmax = the time taken to reach peak paracetamol concentration. The blood samples were analysed for the level of paracetamol, from which the time taken to reach peak paracetamol concentration was subsequently calculated. Blood samples were taken at the same time points as the ultrasound measurements.

    Blood samples taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours

Secondary Outcomes (1)

  • T½

    Measurments taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours.

Study Arms (2)

Black Tea

ACTIVE COMPARATOR
Other: Black tea

Tea with Milk

ACTIVE COMPARATOR
Other: Tea with milk

Interventions

Black teaOTHER

300ml of tea without milk

Black Tea
Tea with milkOTHER

250ml of black tea with 50ml of full fat milk

Tea with Milk

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy non-pregnant volunteers

You may not qualify if:

  • medical conditions with a predisposition to delayed gastric emptying (e.g. diabetes or gastric disease)
  • ingestion of paracetamol within the previous 24 hours
  • ingestion of solids or non-clear liquids in the previous six hours
  • ingestion of clear liquids in the previous two hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (3)

  • Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.

    PMID: 21712716BACKGROUND

  • Wong CA, Loffredi M, Ganchiff JN, Zhao J, Wang Z, Avram MJ. Gastric emptying of water in term pregnancy. Anesthesiology. 2002 Jun;96(6):1395-400. doi: 10.1097/00000542-200206000-00019.

    PMID: 12170052BACKGROUND

  • Darwiche G, Almer LO, Bjorgell O, Cederholm C, Nilsson P. Measurement of gastric emptying by standardized real-time ultrasonography in healthy subjects and diabetic patients. J Ultrasound Med. 1999 Oct;18(10):673-82. doi: 10.7863/jum.1999.18.10.673.

    PMID: 10511299BACKGROUND

MeSH Terms

Interventions

TeaMilk

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDairy ProductsFood

Results Point of Contact

Title
Dr. Sam Hillyard
Organization
GuysThomasNHSTrust / Rockingham General Hospital
sghillyard@yahoo.co.uk
+61424055820

Study Officials

  • Geraldine O'Sullivan

    St Thomas' Hospital, Guy's & St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anaesthetic Registrar

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 13, 2013

Study Start

November 1, 2011

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

December 18, 2013

Results First Posted

October 30, 2013

Record last verified: 2013-11

Locations

GB(1)