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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felipe de la Morena Lopez MD, Hospital Universitario Infanta Cristina
ClinicalTrials.gov Identifier:
NCT01489891
First received: December 3, 2011
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
Results First Received: October 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Esophagogastroduodenoscopy
Interventions: Drug: Lidocaine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Lidocaine Group     Placebo  
STARTED     60     60  
COMPLETED     59     60  
NOT COMPLETED     1     0  
Endoscopy failure                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
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).
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).
Total Total of all reporting groups

Baseline Measures
    Lidocaine Group     Placebo     Total  
Number of Participants  
[units: participants]
 		  59     60     119  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     47     46     93  
>=65 years     12     14     26  
Age  
[units: years]
Mean ± Standard Deviation 		  49.7  ± 15.8     51.7  ± 14.9     50.7  ± 15.3  
Gender  
[units: participants]
 		     
Female     37     38     75  
Male     22     22     44  
Region of Enrollment  
[units: participants]
 		     
Spain     59     60     119  



  Outcome Measures
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1.  Primary:   Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy   [ Time Frame: 8 months ]
  Show Outcome Measure 1

2.  Secondary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist   [ Time Frame: 8 months ]
  Show Outcome Measure 3

4.  Secondary:   Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist   [ Time Frame: 8 months ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Unicenter study  


Results Point of Contact:  
Name/Title: Dr. Felipe de la Morena
Organization: Hospital Universitario Infanta Cristina
phone: 0034659716030
e-mail: felipe_de_la_morena@hotmail.com


Publications of Results:


Responsible Party: Felipe de la Morena Lopez MD, Hospital Universitario Infanta Cristina
ClinicalTrials.gov Identifier: NCT01489891     History of Changes
Other Study ID Numbers: 2011-005704-15, ATF-EGD001
Study First Received: December 3, 2011
Results First Received: October 29, 2012
Last Updated: March 7, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica