Effect of Palatable Lidocaine Gel on Gag Reflex for Patients Undergoing Upper Gastrointestinal Endoscopy
Primary Purpose
Gastro-Intestinal Disorder
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Propofol Injection [Diprivan]
Dexmedetomidine [Precedex]
Palatable Lidocaine Topical Gel
Sponsored by
About this trial
This is an interventional treatment trial for Gastro-Intestinal Disorder focused on measuring palatable lidocaine, dexmedetomidine, gag reflex, gastrointestinal endoscopy
Eligibility Criteria
Inclusion Criteria:
- Patient acceptance. Age 21-60 years old of either sex. BMI < 30 kg/m2 ASA I and ASA II. scheduled for elective upper GIT endoscopy
Exclusion Criteria:
- History of clinically significant cardiovascular, respiratory diseases (as obstructive sleep apnea, severe COPD or asthma) History of psychiatric disease History of allergy to any of the study drugs
Sites / Locations
- Faculty of medicine, zagazig university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
group I (control group)
group II
group III
Arm Description
patients will receive propofol 50 mg
patients will receive propofol 50 mg + dexmedetomidine 0.5 mcg/ kg
patients will receive propofol 50 mg +15 g palatable lidocaine gel
Outcomes
Primary Outcome Measures
Gag reflex
will be assessed as ''present or not" when a vomiting like response will provoked upon introduction of the endoscope.
Secondary Outcome Measures
heart rate
Intraoperative hemodynamics
mean blood pressure
Intraoperative hemodynamics
Patient's satisfaction regarding discomfort (gagging and pain)
will be assessed using numerical rating scale from 1 to 10 (1=satisfied and tolerated well the procedure to 10=unsatisfied)
Endoscopist's satisfaction regarding gagging and difficulty of performing the procedure
using numerical rating scale from 1 to 10 (1=no gagging/difficulty to 10=maximum gagging/ difficulty)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04213833
Brief Title
Effect of Palatable Lidocaine Gel on Gag Reflex for Patients Undergoing Upper Gastrointestinal Endoscopy
Official Title
Effect of Palatable Lidocaine Gel Versus Dexmedetomidine on Gag Reflex During Propofol Based Sedation for Patients Undergoing Elective Upper Gastrointestinal Endoscopy. A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The development of upper gastrointestinal endoscopy (UGIE) has greatly expanded the diagnostic and therapeutic capabilities of gastroenterologists. The patient's tolerance to procedure and endoscopist's satisfaction increase when sedation is used along with topical pharyngeal anesthesia.
Numerous agents are available for moderate sedation in endoscopy such as propofol, midazolam, ketamine, fentanyl and dexmedetomidine, the choice of a particular sedative agent depends on its availability, cost and experience of the endoscopist and patient with that sedative agent. However, these i.v. anesthetics may be associated with complications especially in elderly patients or in those with other comorbidities, as apnea, hypoxia, hypotension, and paradoxical agitation, in which the patient becomes agitated rather than sleepy from the sedation, leading to increased morbidity and the duration of the patient's hospitalization.
Local application of lidocaine to the oral cavity and the oropharynx, will attenuate or even abolish the gag reflex increasing the patient's comfort thus decreasing the dose of i.v. anesthetics with their potential complications.
Up to our knowledge, there is no study done to evaluate the effect of palatable lidocaine gel versus I .v dexmedetomidine on the incidence of gag reflex and total propofol consumption during elective upper gastrointestinal endoscopy.
Detailed Description
Upper gastrointestinal tract endoscopy (UGIE) is a valuable procedure that is commonly used for the diagnosis of possible causes of upper gastrointestinal tract (GIT) symptoms such as bleeding, pain, dysphagia, recurrent vomiting and reflux. Moreover, it is a safe and easy procedure for taking biopsy samples for suspected esophageal, gastric and duodenal diseases, grading and even ligating varices [1, 2].
UGIE is widely performed under propofol sedation that considered a safe sedation technique and alleviates the sympathetic response to the procedure. However, gag reflex and retching still exist in approximately 29% of those patients despite being under propofol sedation [3]. Any further trial of deepening sedation in order to minimize gagging may compromise hemodynamics and cause respiratory depression. These complications add to the overall costs as it increases morbidity and duration of patients' hospitalization. On the other hand, continued gag reflex could affect the safety of the procedure, patient's tolerance and endoscopist's satisfaction [4].
Dexmedetomidine, a short-acting selective α2-agonist, has been used frequently as a sedoanalgesic in many diagnostic and therapeutic procedures [5]. It provides unique sedative activity not present in conventional sedatives so it is unlikely to cause restlessness or respiratory depression was seen with Gaba aminobutyric acid (GABA) receptor agonists such as propofol. Therefore it minimizes physical and emotional distress and enhances successful completion of the procedure without remarkable gag reflex [6]. However, many clinicians may have qualms regarding the safety profile of dexmedetomidine usage in such endoscopic procedures due to its well known hemodynamic side effects (especially bradycardia and hypotension) [7].
Topical pharyngeal anesthesia(TPA) has been used to avoid such complications resulting from deepening sedation through increase i.v anesthetic doses of propofol or adjuvants that may be used as dexmedetomidine. TPA is preferred in many centers, particularly for diagnostic endoscopy [8, 9].
Lidocaine is widely used for TPA. The spray, gel and inhaler forms of it are commercially available. However, application of lidocaine gel to the oral cavity and the oropharynx, especially the base of the tongue, palate, uvula, palatopharyngeal, palatoglossal folds and posterior pharyngeal wall will attenuate or even abolish the gag reflex while introducing the UGIE, thus increasing the patient's comfort and tolerance to the procedure and decreasing the dose of i.v. anesthetics with their potential complications [10, 11].
Palatable lidocaine gel is a local anesthetic that stabilizes the neuronal membrane through hindering the ionic fluxes that initiate and transmit impulses, thereby giving a local anesthetic action. It is a safe, well-tolerated and quite promising TPA particularly in elderly patients and in patients with comorbidities in office-based endoscopy [12].
We hypothesize that the usage of topical palatable lidocaine gel may have an impact on decreasing the incidence of gag reflex and total propofol consumption during upper gastrointestinal endoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-Intestinal Disorder
Keywords
palatable lidocaine, dexmedetomidine, gag reflex, gastrointestinal endoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
participant and endoscopist
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group I (control group)
Arm Type
Placebo Comparator
Arm Description
patients will receive propofol 50 mg
Arm Title
group II
Arm Type
Active Comparator
Arm Description
patients will receive propofol 50 mg + dexmedetomidine 0.5 mcg/ kg
Arm Title
group III
Arm Type
Active Comparator
Arm Description
patients will receive propofol 50 mg +15 g palatable lidocaine gel
Intervention Type
Drug
Intervention Name(s)
Propofol Injection [Diprivan]
Intervention Description
patients will be sedated with 50 mg propofol(10 mg/ml) given slowly intravenously over 1 min
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine [Precedex]
Other Intervention Name(s)
propofol
Intervention Description
patients will received 0.5 mcg/ kg dexmedetomidine intravenously followed by syringe containing 50 mg propofol(10 mg/ml).
Intervention Type
Drug
Intervention Name(s)
Palatable Lidocaine Topical Gel
Other Intervention Name(s)
propofol
Intervention Description
15 g of palatable lidocaine gel will be gradually applied 3-5 min before the endoscopy at three consecutive 30-s intervals to the base of the tongue, the palate and the peritonsillar areas and the patients will be informed to spread it within their mouth with their tongue and swallow it later to cover the oropharynx and esophagus. Patients will be asked to register the onset of numbness, then patient will receive syringe containing 50 mg propofol (10 mg/ml) intravenously as a sedation.
Primary Outcome Measure Information:
Title
Gag reflex
Description
will be assessed as ''present or not" when a vomiting like response will provoked upon introduction of the endoscope.
Time Frame
through endoscopic procedure up to one hour
Secondary Outcome Measure Information:
Title
heart rate
Description
Intraoperative hemodynamics
Time Frame
every 2 min for the first 10 min of the procedure, then every 5 min till the end of the procedure.
Title
mean blood pressure
Description
Intraoperative hemodynamics
Time Frame
every 2 min for the first 10 min of the procedure, then every 5 min till the end of the procedure.
Title
Patient's satisfaction regarding discomfort (gagging and pain)
Description
will be assessed using numerical rating scale from 1 to 10 (1=satisfied and tolerated well the procedure to 10=unsatisfied)
Time Frame
2 hours post the procedure
Title
Endoscopist's satisfaction regarding gagging and difficulty of performing the procedure
Description
using numerical rating scale from 1 to 10 (1=no gagging/difficulty to 10=maximum gagging/ difficulty)
Time Frame
through endoscopic procedure up to one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient acceptance. Age 21-60 years old of either sex. BMI < 30 kg/m2 ASA I and ASA II. scheduled for elective upper GIT endoscopy
Exclusion Criteria:
History of clinically significant cardiovascular, respiratory diseases (as obstructive sleep apnea, severe COPD or asthma) History of psychiatric disease History of allergy to any of the study drugs
Facility Information:
Facility Name
Faculty of medicine, zagazig university
City
Zagazig
State/Province
Elsharqya
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
planned after the completion of the study and publication
IPD Sharing Time Frame
planned after the completion of the study and publication
IPD Sharing Access Criteria
contact of principal investigator
Citations:
Citation
Ghallab M, Hussien RM, Samir GM, Ibrhaim DA. Palatal lidocaine gel as an adjuvant to propofol versus propofol only for sedation during upper gastrointestinal tract endoscopy: a comparative study. Ain-Shams J Anesthesiol 2014; 7:524-9.
Results Reference
background
Citation
Samson S, George SK, Vinoth B, Khan MS, Akila B. Comparison of dexmedetomidine, midazolam, and propofol as an optimal sedative for upper gastrointestinal endoscopy: A randomized controlled trial. Journal of Digestive Endoscopy 2014;5(2) :51-7.
Results Reference
background
PubMed Identifier
4835444
Citation
Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
Results Reference
background
PubMed Identifier
15153854
Citation
Bassi GS, Humphris GM, Longman LP. The etiology and management of gagging: a review of the literature. J Prosthet Dent. 2004 May;91(5):459-67. doi: 10.1016/S0022391304000939.
Results Reference
background
Citation
Abbas I, Hassanein A, Mokhtar M. Effect of low dose ketamine versus dexmedetomidine on gag reflex during propofol based sedation during upper gastrointestinal endoscopy. A randomized controlled study. Egyptian Journal of Anaesthesia 2017;33: 165-70.
Results Reference
background
PubMed Identifier
22000794
Citation
Heuss LT, Hanhart A, Dell-Kuster S, Zdrnja K, Ortmann M, Beglinger C, Bucher HC, Degen L. Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial. Gastrointest Endosc. 2011 Dec;74(6):1207-14. doi: 10.1016/j.gie.2011.07.072. Epub 2011 Oct 13.
Results Reference
result
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Effect of Palatable Lidocaine Gel on Gag Reflex for Patients Undergoing Upper Gastrointestinal Endoscopy
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