Comparison of Topical and Nebulized Anesthesia in Patients Undergoing Esophago-Gastro-Duodenoscopy
1 other identifier
interventional
110
1 country
1
Brief Summary
This study compares the effect of nebulized lidocaine and lidocaine spray in patients undergoing esophago-gastro-duodenoscopy. The investigators evaluate the success rate of the procedure between two methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 11, 2014
CompletedFirst Posted
Study publicly available on registry
December 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMarch 16, 2016
March 1, 2016
2.3 years
December 11, 2014
March 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of Topical and Nebulized Anesthesia
Both nurse anesthetist and endoscopist evaluate difficulty during the procedure and demand for additional sedative drugs using numeric scale
90 min
Secondary Outcomes (2)
Patient Satisfaction
90 min
Operator Satisfaction
30 min
Study Arms (2)
Lidocaine Spray
ACTIVE COMPARATOR20 puffs of 10% Lidocaine spray
Nebulized Lidocaine
ACTIVE COMPARATOR2.5 mL of 10% Lidocaine
Interventions
5 puffs of 10% Lidocaine spray is administered every 5 minutes for 4 times. Then the patient is undergone procedure 5 minutes later.
The patient receives 2.5 mL of 10% lidocaine is used by nebulizer under oxygen flow 6-7 LPM for 15 minutes prior the procedure.
Eligibility Criteria
You may qualify if:
- elective case for esophago-gastro-duodenoscopy with ASA classification 1-2
- Both genders
- Age between 18-65 years
You may not qualify if:
- History of smoking
- Upper respiratory tract infection
- Asthma
- Heart disease
- Allergy to local anesthetic drugs
- Withdrawal or termination criteria
- Patient refusal
- Patient develops lidocaine allergy
- Bronchospasm
- Sign of Local Anesthetic Toxicity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
Related Publications (2)
Korttila K, Tarkkanen J, Tarkkanen L. Comparison of laryngotracheal and ultrasonic nebulizer administration of lidocaine in local anaesthesia for bronchoscopy. Acta Anaesthesiol Scand. 1981 Apr;25(2):161-5. doi: 10.1111/j.1399-6576.1981.tb01628.x.
PMID: 7324824BACKGROUNDDhir V, Swaroop VS, Vazifdar KF, Wagle SD. Topical pharyngeal anesthesia without intravenous sedation during upper gastrointestinal endoscopy. Indian J Gastroenterol. 1997 Jan;16(1):10-1.
PMID: 9167371BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Papiroon Noitasaeng, RN
Department of Anesthesia, Faculty of Medicine Siriraj Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2014
First Posted
December 16, 2014
Study Start
November 1, 2013
Primary Completion
March 1, 2016
Study Completion
April 1, 2016
Last Updated
March 16, 2016
Record last verified: 2016-03