Usefulness of Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopy Under Sedation With Propofol
|ClinicalTrials.gov Identifier: NCT01489891|
Recruitment Status : Completed
First Posted : December 12, 2011
Results First Posted : March 8, 2013
Last Update Posted : March 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Esophagogastroduodenoscopy||Drug: Lidocaine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Usefulness of Applying Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopies Performed Under Sedation With Propofol- a Randomized Controlled Trial|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
Active Comparator: Lidocaine group
Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)
Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).
Placebo Comparator: Placebo
Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).
- 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).
- 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 ]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.
- Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist [ Time Frame: 8 months ]Define as easiness to reach the expected objectives for endoscopy without patient interference: very satisfied, satisfied, neutral, unsatisfied.
- Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist [ Time Frame: 8 months ]Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489891
|Hospital Universitario Infanta Cristina|
|Parla, Madrid, Spain, 28980|
|Principal Investigator:||Felipe de la Morena, M.D.|