Phase 4
N=120
Usefulness of Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopy Under Sedation With Propofol
Esophagogastroduodenoscopy
Bottom Line
View on ClinicalTrials.gov: NCT01489891 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy — 310.7; 280.1 mcg/kg/min — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lidocaine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital Universitario Infanta Cristina
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy |
310.7; 280.1 | <0.05 sig |
| SECONDARY Percentage of Participants With Adverse Events in Both Groups |
32.2; 26.7 | — |
| SECONDARY Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist |
6.8; 0; 10.1; 15; 25.4; 18.3 | — |
| SECONDARY Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist |
5.8; 0; 16.9; 16.7; 15.2; 20.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01489891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.