Trial Outcomes & Findings for Usefulness of Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopy Under Sedation With Propofol (NCT NCT01489891)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

120 participants

Primary outcome timeframe

8 months

Results posted on

2013-03-08

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	60	60
Overall Study COMPLETED	59	60
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).
Overall Study Endoscopy failure	1	0

Baseline Characteristics

Usefulness of Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopy Under Sedation With Propofol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine Group n=59 Participants 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).	Placebo n=60 Participants 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).	Total n=119 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	46 Participants n=7 Participants	93 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Age Continuous	49.7 years STANDARD_DEVIATION 15.8 • n=5 Participants	51.7 years STANDARD_DEVIATION 14.9 • n=7 Participants	50.7 years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment Spain	59 participants n=5 Participants	60 participants n=7 Participants	119 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Lidocaine Group n=59 Participants 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).	Placebo n=60 Participants 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).
Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy	310.7 mcg/kg/min Standard Deviation 139.2	280.1 mcg/kg/min Standard Deviation 87.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lidocaine Group n=59 Participants 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).	Placebo n=60 Participants 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).
Percentage of Participants With Adverse Events in Both Groups	32.2 percentage of participants Interval 21.6 to 45.0	26.7 percentage of participants Interval 17.0 to 39.0

SECONDARY outcome

Timeframe: 8 months

Define as easiness to reach the expected objectives for endoscopy without patient interference: very satisfied, satisfied, neutral, unsatisfied.

Outcome measures

Outcome measures
Measure	Lidocaine Group n=59 Participants 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).	Placebo n=60 Participants 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).
Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist Unsatisfactory	6.8 percentage of participants Interval 2.2 to 15.5	0 percentage of participants Interval 0.0 to 4.8
Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist Neutral	10.1 percentage of participants Interval 4.2 to 19.9	15 percentage of participants Interval 7.6 to 25.7
Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist Satisfactory	25.4 percentage of participants Interval 10.0 to 29.6	18.3 percentage of participants Interval 15.5 to 37.6
Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist Very satisfactory	57.6 percentage of participants Interval 54.0 to 77.7	66.6 percentage of participants Interval 44.8 to 69.7

SECONDARY outcome

Timeframe: 8 months

Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied.

Outcome measures

Outcome measures
Measure	Lidocaine Group n=59 Participants 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).	Placebo n=60 Participants 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).
Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist Very satisfactory	62.7 percentage of participants Interval 49.9 to 74.3	63.3 percentage of participants Interval 50.6 to 74.7
Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist Unsatisfactory	5.8 percentage of participants Interval 1.3 to 13.2	0 percentage of participants Interval 0.0 to 4.8
Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist Neutral	16.9 percentage of participants Interval 8.9 to 28.4	16.7 percentage of participants Interval 8.8 to 27.7
Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist Satisfactory	15.2 percentage of participants Interval 7.7 to 26.1	20.3 percentage of participants Interval 11.3 to 31.6

Adverse Events

Lidocaine Group

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lidocaine Group n=59 participants at risk 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).	Placebo n=60 participants at risk 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).
Respiratory, thoracic and mediastinal disorders Desaturation	18.6% 11/59 • 8 months	15.0% 9/60 • 8 months
Vascular disorders Hypotension	20.3% 12/59 • 8 months	18.3% 11/60 • 8 months
Cardiac disorders Bradycardia	3.4% 2/59 • 8 months	6.7% 4/60 • 8 months

Additional Information

Dr. Felipe de la Morena

Hospital Universitario Infanta Cristina

Phone: 0034659716030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place