Upper Gastrointestinal EndoscopyENDOGLUcideNCT01471600
Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia
A study testing group drink in people with Upper Gastrointestinal Endoscopy, run by University Hospital, Caen at 1 site in France.
Trial summary
In several national anaesthesia societies, clear fluids are allowed up to 2 hours before general anaesthesia (GA) and light meals up to 6h. Because of aspiration risk, strict fasting remains routine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Gastrointestinal Endoscopy
- What is being tested?
- group drink
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >= 18 yrs
- undergoing upper endoscopy procedure under general anesthesia without emergency
- informed written consent
Who cannot join
- emergency
- might impair gastrointestinal motility (intestinal obstruction, stenosis)
- diseases of the central and peripheral nervous system or neuromuscular diseases
- drug-induced gastric emptying disorders
- pregnancy
- ionic disorders (hyponatremia<125mmol/l ; hypokalemia<3,5mmol/l
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- hemodynamic disorders (systolic arterial pressure <100mmHg)
- unstable diabetes (glycemia>2,5g/l) ± insulin- dependent diabetes ± diabetic gastroparesis
- the potential for difficult airway management
- understanding of the information
- patient with bad prognosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Study : Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia
In several national anaesthesia societies, clear fluids are allowed up to 2 hours before general anaesthesia (GA) and light meals up to 6h. Because of aspiration risk, strict fasting remains routine. Recently, surgical studies proved that pre-operative carbohydrate-rich drink reduces preoperative discomfort without affecting gastric fluid volume and acidity.The aim of this study was to show the effects of preanaesthetic oral fluid in patients undergoing upper endoscopy without emergency. The expected efficacy is a reduction of the preoperative discomfort. The investigators thus propose a randomised prospective open-label study to assess efficacy of preanaesthetic oral glucose drink in patients undergoing upper endoscopy without emergency. Study compare two groups : group "drink" (200 ml of fruit juice without pulp ± 200 ml of coffee or tea, 2 at 4 hours before the induction of anaesthesia) and group "overnight fasting".Discomfort was measured at 2 hours before GA (H-2), just before GA (H0) and 4h after anaesthesia (H+4). Each item (anxiety, thirst, hunger, nervousness, tiredness, nausea) was estimated by visual analogue scale (VAS from 0 to 100mm) and handgrip strength by dynamometer. Gastroenterologist assessed the quality of endoscopy (VAS), gastric residual fluid and acidity.The main aim of this study was to assess in patients referred for upper endoscopy under general anaesthesia, the effect of carbohydrate drink on preanaesthetic discomfort. Secondary purpose were to compare quality of endoscopy, residual gastric volumes, gastric acidity and incidence of side effects. 118 patients will be included in the study. A stratification will be made on the type of endoscopy.
- Conditions
- Upper Gastrointestinal Endoscopy
- Being tested
- group drink
- Keywords
- upper gastrointestinal endoscopy, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group drinkProcedure or surgery
group glucose drink : 200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Group overnight fasting |
| Group drink | Active comparator | Glucose drink (200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia) Receives: Procedure: group drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of preoperative patients increasing the anxiety score just before anaesthesia (H0)
percentage of patients who increased the anxiety score (Visual Analogue Scale of Anxiety) just before anaesthesia.
Measured: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.
Secondary outcomes (7)
discomfort (anxiety, thirst, hunger, nervousness, nausea, tiredness) assessed by visual analogue scale (VAS) just before anaesthesia
discomfort (anxiety, thirst, hunger, nervousness, nausea, tiredness) assessed by visual analogue scale (VAS from 0 to 100mmm) just before anaesthesia (at H0).
Measured: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.
handgrip strength assessed by dynamometer just before anaesthesia
handgrip strength assessed by dynamometer just before anaesthesia
Measured: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.
quality of endoscopy estimated by gastroenterologist by visual analogue scale (VAS from 0 to 100mm)
quality of endoscopy estimated by gastroenterologist by visual analogue scale (VAS from 0 to 100mm)
Measured: The participants will be followed for the duration of hospital stay, an expected average of one day.
gastric residual volume (ml)
gastric residual volume (ml)
Measured: The participants will be followed for the duration of hospital stay, an expected average of one day.
amount of propofol (mg)
the propofol consumption (mg)
Measured: The participants will be followed for the duration of hospital stay, an expected average of one day.
gastric acidity (pH)
gastric acidity (pH) measured by pH indicator paper
Measured: The participants will be followed for the duration of hospital stay, an expected average of one day.
occurrence of vomiting
occurrence of vomiting
Measured: The participants will be followed for the duration of hospital stay, an expected average of one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startMay 2008
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie A PIQUET, PhD MD, Principal investigator, CAEN, Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471600
- Sponsor's protocol ID
- 2008-A00255-50
- Other IDs
- 08-009
- Acronym
- ENDOGLUcide
- Status last verified
- Feb 2013
- First submitted
- 18 Oct 2011
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study : Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT01471600
- Acronym / sponsor ID
- ENDOGLUcide / 2008-A00255-50
- Conditions
- Upper Gastrointestinal Endoscopy
- Keywords
- upper gastrointestinal endoscopy, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In several national anaesthesia societies, clear fluids are allowed up to 2 hours before general anaesthesia (GA) and light meals up to 6h. Because of aspiration risk, strict fasting remains routine. Recently, surgical studies proved that pre-operative carbohydrate-rich drink reduces preoperative discomfort without affecting gastric fluid volume and acidity.The aim of this study was to show the effects of preanaesthetic oral fluid in patients undergoing upper endoscopy without emergency. The expected efficacy is a reduction of the preoperative discomfort. The investigators thus propose a randomised prospective open-label study to assess efficacy of preanaesthetic oral glucose drink in patients undergoing upper endoscopy without emergency. Study compare two groups : group "drink" (200 ml of fruit juice without pulp ± 200 ml of coffee or tea, 2 at 4 hours before the induction of anaesthesia) and group "overnight fasting".Discomfort was measured at 2 hours before GA (H-2), just before GA (H0) and 4h after anaesthesia (H+4). Each item (anxiety, thirst, hunger, nervousness, tiredness, nausea) was estimated by visual analogue scale (VAS from 0 to 100mm) and handgrip strength by dynamometer. Gastroenterologist assessed the quality of endoscopy (VAS), gastric residual fluid and acidity.The main aim of this study was to assess in patients referred for upper endoscopy under general anaesthesia, the effect of carbohydrate drink on preanaesthetic discomfort. Secondary purpose were to compare quality of endoscopy, residual gastric volumes, gastric acidity and incidence of side effects. 118 patients will be included in the study. A stratification will be made on the type of endoscopy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Group overnight fasting |
| Group drink | Active comparator | Procedure: group drinkGlucose drink (200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age >= 18 yrs
- undergoing upper endoscopy procedure under general anesthesia without emergency
- informed written consent
Key exclusion criteria (11 listed)
- emergency
- might impair gastrointestinal motility (intestinal obstruction, stenosis)
- diseases of the central and peripheral nervous system or neuromuscular diseases
- drug-induced gastric emptying disorders
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group drinkgroup glucose drink : 200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia | Procedure or surgery | Group drink |
Primary outcome
percentage of preoperative patients increasing the anxiety score just before anaesthesia (H0)
Time frame: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.
percentage of patients who increased the anxiety score (Visual Analogue Scale of Anxiety) just before anaesthesia.
7 secondary outcomes
discomfort (anxiety, thirst, hunger, nervousness, nausea, tiredness) assessed by visual analogue scale (VAS) just before anaesthesia
Time frame: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.
handgrip strength assessed by dynamometer just before anaesthesia
Time frame: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.
quality of endoscopy estimated by gastroenterologist by visual analogue scale (VAS from 0 to 100mm)
Time frame: The participants will be followed for the duration of hospital stay, an expected average of one day.
gastric residual volume (ml)
Time frame: The participants will be followed for the duration of hospital stay, an expected average of one day.
amount of propofol (mg)
Time frame: The participants will be followed for the duration of hospital stay, an expected average of one day.
gastric acidity (pH)
Time frame: The participants will be followed for the duration of hospital stay, an expected average of one day.
occurrence of vomiting
Time frame: The participants will be followed for the duration of hospital stay, an expected average of one day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie A PIQUET, PhD MD principal investigator
CAEN, Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group drink in people with Upper Gastrointestinal Endoscopy, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of preoperative patients increasing the anxiety score just before anaesthesia (H0) (time frame: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.