EsophagogastroduodenoscopyPhase 4NCT01489891
Usefulness of Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopy Under Sedation With Propofol
A Phase 4 study testing Lidocaine in people with Esophagogastroduodenoscopy, run by Hospital Universitario Infanta Cristina at 1 site in Spain.
Trial summary
The purpose of this study is to determine the efficacy of application of the anaesthesia topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation, in therms of dosage and side effect´s reduction overall. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophagogastroduodenoscopy
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2011to Aug 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient´s over 18 years old that received standard indication for sedated esophagogastroduodenoscopy (American Society of Gastrointestinal Endoscopy Guidelines) in our centre between the period of study.
Who cannot join
- Patients under 18 years old
- Unable to obtain inform´s consent
- Emergency endoscopy
- Pregnant women
- Encephalopathy
- Well known allergic reaction to propofol, amide-anaesthesics, soy or eggs
- Methaemoglobinemia induced factor risks
- No previous or unknown fasting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Applying Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopies Performed Under Sedation With Propofol- a Randomized Controlled Trial
The purpose of this study is to determine the efficacy of application of the anaesthesia topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation, in therms of dosage and side effect´s reduction overall.
- Conditions
- Esophagogastroduodenoscopy
- Being tested
- Lidocaine, Placebo
- Keywords
- Esophagogastroduodenoscopy, Lidocaine, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).
PlaceboDrug
Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Active comparator | Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD) Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy
The propofol will be administered by an expert anaesthetist in repeated bolus (10-20 mg each 30-60 seconds) after an initial induction dosage (0.5-0.6 mg/kg ASA (American Society of Anaesthesiologists) I-II or 0.25-0.35 mg/kg ASA III-IV) to obtain an uniform level of sedation (OAAS 3 and bispectral index (BIS) 70-80) and adequate perceived patient tolerance (no gag-reflex, cough, sudden movements).
Measured: 8 months
Secondary outcomes (3)
Percentage of Participants With Adverse Events in Both Groups
Hypoxemia (SatO2<90% or >4% if the baseline was under 93%), bradycardia (<60 bpm or >10% from baseline), hypotension (systolic blood pressure under 90 mmHg and/or diastolic 60 mmHg), anaphylactic reaction, aspiration o methaemoglobinemia.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure
Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist
Define as easiness to reach the expected objectives for endoscopy without patient interference: very satisfied, satisfied, neutral, unsatisfied.
Measured: 8 months
Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist
Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for EsophagogastroduodenoscopyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Infanta Cristina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe de la Morena Lopez MD, Hospital Universitario Infanta Cristina
- Investigators
- Felipe de la Morena, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489891
- Sponsor's protocol ID
- 2011-005704-15
- Other IDs
- ATF-EGD001
- Status last verified
- Mar 2013
- First submitted
- 3 Dec 2011
- Last updated
- 8 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jimenez-Puente G, Hidalgo-Isla M. [Use of topical pharyngeal anaesthesia in esophagogastroduodenoscopy in unsedated patients]. Enferm Clin. 2011 Jan-Feb;21(1):30-4. doi: 10.1016/j.enfcli.2010.07.008. Epub 2011 Feb 18. Spanish.
PubMed 21334240Amornyotin S, Srikureja W, Chalayonnavin W, Kongphlay S, Chatchawankitkul S. Topical viscous lidocaine solution versus lidocaine spray for pharyngeal anesthesia in unsedated esophagogastroduodenoscopy. Endoscopy. 2009 Jul;41(7):581-6. doi: 10.1055/s-0029-1214865. Epub 2009 Jul 8.
PubMed 19588284Evans LT, Saberi S, Kim HM, Elta GH, Schoenfeld P. Pharyngeal anesthesia during sedated EGDs: is "the spray" beneficial? A meta-analysis and systematic review. Gastrointest Endosc. 2006 May;63(6):761-6. doi: 10.1016/j.gie.2005.11.059.
PubMed 16650534Lachter J, Jacobs R, Lavy A, Weisler A, Suissa A, Enat R, Eidelman S. Topical pharyngeal anesthesia for easing endoscopy: a double-blind, randomized, placebo-controlled study. Gastrointest Endosc. 1990 Jan-Feb;36(1):19-21. doi: 10.1016/s0016-5107(90)70915-7.
PubMed 2179038Mulcahy HE, Greaves RR, Ballinger A, Patchett SE, Riches A, Fairclough PD, Farthing MJ. A double-blind randomized trial of low-dose versus high-dose topical anaesthesia in unsedated upper gastrointestinal endoscopy. Aliment Pharmacol Ther. 1996 Dec;10(6):975-9. doi: 10.1046/j.1365-2036.1996.89261000.x.
PubMed 8971297Ristikankare M, Hartikainen J, Heikkinen M, Julkunen R. Is routine sedation or topical pharyngeal anesthesia beneficial during upper endoscopy? Gastrointest Endosc. 2004 Nov;60(5):686-94. doi: 10.1016/s0016-5107(04)02048-6.
PubMed 15557943Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anaesthesiologist administration of propofol for GI endoscopy. Eur J Anaesthesiol. 2010 Dec;27(12):1016-30. doi: 10.1097/EJA.0b013e32834136bf.
PubMed 21068575
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Applying Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopies Performed Under Sedation With Propofol- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01489891
- Acronym / sponsor ID
- 2011-005704-15
- Conditions
- Esophagogastroduodenoscopy
- Keywords
- Esophagogastroduodenoscopy, Lidocaine, Propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital Universitario Infanta CristinaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 12 Dec 2011 (estimated)
- Results
- Posted 8 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy of application of the anaesthesia topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation, in therms of dosage and side effect´s reduction overall.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Active comparator | Drug: LidocaineBlinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD) |
| Placebo | Placebo comparator | Drug: PlaceboExcipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient´s over 18 years old that received standard indication for sedated esophagogastroduodenoscopy (American Society of Gastrointestinal Endoscopy Guidelines) in our centre between the period of study.
Key exclusion criteria (8 listed)
- Patients under 18 years old
- Unable to obtain inform´s consent
- Emergency endoscopy
- Pregnant women
- Encephalopathy
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 |
|---|---|---|
| LidocaineApplying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff). | Drug | Lidocaine group |
| PlaceboApplying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking). | Drug | Placebo |
Primary outcome
Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy
Time frame: 8 months
The propofol will be administered by an expert anaesthetist in repeated bolus (10-20 mg each 30-60 seconds) after an initial induction dosage (0.5-0.6 mg/kg ASA (American Society of Anaesthesiologists) I-II or 0.25-0.35 mg/kg ASA III-IV) to obtain an uniform level of sedation (OAAS 3 and bispectral index (BIS) 70-80) and adequate perceived patient tolerance (no gag-reflex, cough, sudden movements).
3 secondary outcomes
Percentage of Participants With Adverse Events in Both Groups
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure
Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist
Time frame: 8 months
Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist
Time frame: 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21334240Jimenez-Puente G, Hidalgo-Isla M. [Use of topical pharyngeal anaesthesia in esophagogastroduodenoscopy in unsedated patients]. Enferm Clin. 2011 Jan-Feb;21(1):30-4. doi: 10.1016/j.enfcli.2010.07.008. Epub 2011 Feb 18. Spanish.
- Results publication: PubMed 19588284Amornyotin S, Srikureja W, Chalayonnavin W, Kongphlay S, Chatchawankitkul S. Topical viscous lidocaine solution versus lidocaine spray for pharyngeal anesthesia in unsedated esophagogastroduodenoscopy. Endoscopy. 2009 Jul;41(7):581-6. doi: 10.1055/s-0029-1214865. Epub 2009 Jul 8.
- Results publication: PubMed 16650534Evans LT, Saberi S, Kim HM, Elta GH, Schoenfeld P. Pharyngeal anesthesia during sedated EGDs: is "the spray" beneficial? A meta-analysis and systematic review. Gastrointest Endosc. 2006 May;63(6):761-6. doi: 10.1016/j.gie.2005.11.059.
- Results publication: PubMed 2179038Lachter J, Jacobs R, Lavy A, Weisler A, Suissa A, Enat R, Eidelman S. Topical pharyngeal anesthesia for easing endoscopy: a double-blind, randomized, placebo-controlled study. Gastrointest Endosc. 1990 Jan-Feb;36(1):19-21. doi: 10.1016/s0016-5107(90)70915-7.
- Results publication: PubMed 8971297Mulcahy HE, Greaves RR, Ballinger A, Patchett SE, Riches A, Fairclough PD, Farthing MJ. A double-blind randomized trial of low-dose versus high-dose topical anaesthesia in unsedated upper gastrointestinal endoscopy. Aliment Pharmacol Ther. 1996 Dec;10(6):975-9. doi: 10.1046/j.1365-2036.1996.89261000.x.
- Results publication: PubMed 15557943Ristikankare M, Hartikainen J, Heikkinen M, Julkunen R. Is routine sedation or topical pharyngeal anesthesia beneficial during upper endoscopy? Gastrointest Endosc. 2004 Nov;60(5):686-94. doi: 10.1016/s0016-5107(04)02048-6.
- Results publication: PubMed 21068575Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anaesthesiologist administration of propofol for GI endoscopy. Eur J Anaesthesiol. 2010 Dec;27(12):1016-30. doi: 10.1097/EJA.0b013e32834136bf.
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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.
Felipe de la Morena, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine in people with Esophagogastroduodenoscopy, run by Hospital Universitario Infanta Cristina at 1 site in Spain.
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 1 inclusion and 8 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 8 Mar 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01489891, which also lists 7 linked publications.
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 8 Mar 2013.