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| ID | Type | Description | Link |
|---|---|---|---|
| ATF-EGD001 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine group | Active Comparator | Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD) |
|
| Placebo | Placebo Comparator | Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe de la Morena, M.D. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Infanta Cristina | Parla | Madrid | 28980 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21334240 | Result | 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. | |
| 19588284 | Result | Amornyotin 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. |
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The exclusion criteria were instructions for urgent endoscopy, encephalopathy, zero patient cooperation, lack of informed consent, not having fasted, a history to developing methemoglobinemia, pregnant women, lactating mothers or known allergies to propofol or lidocaine. All the patients provided their informed consent beforehand
All patients over 18y with instructions for diagnostic or therapeutic EGD referred to the Endoscopy Unit of the Infanta Cristina Hospital for sedation were included successively. All patients was referred to the Infanta Cristina Hospital Endoscopy Unit in Parla, Madrid, Spain, for an EGD between January and May 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine Group | Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD) Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff). |
| FG001 | Placebo | Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking. Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine Group | Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff). |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | mcg/kg/min | 8 months |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine Group | Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Desaturation is defined as in drop in SatO2<90% or >4% with respect to the basal figure if it were ≤93%. |
Unicenter study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Felipe de la Morena | Hospital Universitario Infanta Cristina | 0034659716030 | felipe_de_la_morena@hotmail.com |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking). |
|
| 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. | 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. | 8 months |
| 16650534 | Result | Evans 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. |
| 2179038 | Result | Lachter 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. |
| 8971297 | Result | Mulcahy 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. |
| 15557943 | Result | Ristikankare 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. |
| 21068575 | Result | Dumonceau 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. |
Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking. Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking). |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 months |
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|
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 months |
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| 0 |
| 59 |
| 19 |
| 59 |
| EG001 | Placebo | Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking. Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking). | 0 | 60 | 16 | 60 |
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| Hypotension | Vascular disorders | Systematic Assessment | Hypotension is defined as a drop in systolic blood pressure < 90 mmHg or in diastolic blood pressure < 60 mmHg |
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| Bradycardia | Cardiac disorders | Systematic Assessment | Bradycardia is defined as a <60 bmp drop in heart rate during the procedure or a >10% drop in relation to the basal figure |
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| Aniline Compounds |
| D000588 | Amines |
| Satisfactory |
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| Very satisfactory |
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| Satisfactory |
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| Very satisfactory |
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