Esophagogastroduodenoscopy
Conditions
Keywords
Esophagogastroduodenoscopy, Lidocaine, Propofol
Brief 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.
Interventions
DRUGLidocaine
Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).
DRUGPlacebo
Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).
Sponsors
Hospital Universitario Infanta Cristina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events in Both Groups | 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 | 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 | 8 months | Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied. |
Countries
Spain
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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). | 59 |
| 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). | 60 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Endoscopy failure | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Lidocaine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 12 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 47 Participants | 93 Participants |
| Age Continuous | 51.7 years STANDARD_DEVIATION 14.9 | 49.7 years STANDARD_DEVIATION 15.8 | 50.7 years STANDARD_DEVIATION 15.3 |
| Region of Enrollment Spain | 60 participants | 59 participants | 119 participants |
| Sex: Female, Male Female | 38 Participants | 37 Participants | 75 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 59 | 16 / 60 |
| serious Total, serious adverse events | 0 / 59 | 0 / 60 |
Outcome results
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).
Time frame: 8 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Group | Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy | 310.7 mcg/kg/min | Standard Deviation 139.2 |
| Placebo | Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy | 280.1 mcg/kg/min | Standard Deviation 87.7 |
p-value: <0.05t-test, 2 sided
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.
Time frame: 8 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lidocaine Group | Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist | Unsatisfactory | 5.8 percentage of participants |
| Lidocaine Group | Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist | Neutral | 16.9 percentage of participants |
| Lidocaine Group | Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist | Satisfactory | 15.2 percentage of participants |
| Lidocaine Group | Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist | Very satisfactory | 62.7 percentage of participants |
| Placebo | Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist | Very satisfactory | 63.3 percentage of participants |
| Placebo | Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist | Unsatisfactory | 0 percentage of participants |
| Placebo | Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist | Satisfactory | 20.3 percentage of participants |
| Placebo | Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist | Neutral | 16.7 percentage of participants |
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.
Time frame: 8 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lidocaine Group | Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist | Unsatisfactory | 6.8 percentage of participants |
| Lidocaine Group | Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist | Neutral | 10.1 percentage of participants |
| Lidocaine Group | Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist | Satisfactory | 25.4 percentage of participants |
| Lidocaine Group | Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist | Very satisfactory | 57.6 percentage of participants |
| Placebo | Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist | Very satisfactory | 66.6 percentage of participants |
| Placebo | Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist | Unsatisfactory | 0 percentage of participants |
| Placebo | Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist | Satisfactory | 18.3 percentage of participants |
| Placebo | Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist | Neutral | 15 percentage of participants |
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.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine Group | Percentage of Participants With Adverse Events in Both Groups | 32.2 percentage of participants |
| Placebo | Percentage of Participants With Adverse Events in Both Groups | 26.7 percentage of participants |