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Effect of Palatable Lidocaine Gel on Gag Reflex for Patients Undergoing Upper Gastrointestinal Endoscopy

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ClinicalTrials.gov Identifier: NCT04213833
Recruitment Status : Completed
First Posted : December 30, 2019
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Shereen Elsayed Abd Ellatif, Zagazig University

Tracking Information
First Submitted Date  ICMJE December 23, 2019
First Posted Date  ICMJE December 30, 2019
Last Update Posted Date August 7, 2020
Actual Study Start Date  ICMJE January 1, 2020
Actual Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2019)
Gag reflex [ Time Frame: through endoscopic procedure up to one hour ]
will be assessed as ''present or not" when a vomiting like response will provoked upon introduction of the endoscope.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2019)
  • heart rate [ Time Frame: every 2 min for the first 10 min of the procedure, then every 5 min till the end of the procedure. ]
    Intraoperative hemodynamics
  • mean blood pressure [ Time Frame: every 2 min for the first 10 min of the procedure, then every 5 min till the end of the procedure. ]
    Intraoperative hemodynamics
  • Patient's satisfaction regarding discomfort (gagging and pain) [ Time Frame: 2 hours post the procedure ]
    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 [ Time Frame: through endoscopic procedure up to one hour ]
    using numerical rating scale from 1 to 10 (1=no gagging/difficulty to 10=maximum gagging/ difficulty)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Palatable Lidocaine Gel on Gag Reflex for Patients Undergoing Upper Gastrointestinal Endoscopy
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
participant and endoscopist
Primary Purpose: Treatment
Condition  ICMJE Gastro-Intestinal Disorder
Intervention  ICMJE
  • Drug: Propofol Injection [Diprivan]
    patients will be sedated with 50 mg propofol(10 mg/ml) given slowly intravenously over 1 min
  • Drug: Dexmedetomidine [Precedex]
    patients will received 0.5 mcg/ kg dexmedetomidine intravenously followed by syringe containing 50 mg propofol(10 mg/ml).
    Other Name: propofol
  • Drug: Palatable Lidocaine Topical Gel
    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.
    Other Name: propofol
Study Arms  ICMJE
  • Placebo Comparator: group I (control group)
    patients will receive propofol 50 mg
    Intervention: Drug: Propofol Injection [Diprivan]
  • Active Comparator: group II
    patients will receive propofol 50 mg + dexmedetomidine 0.5 mcg/ kg
    Intervention: Drug: Dexmedetomidine [Precedex]
  • Active Comparator: group III
    patients will receive propofol 50 mg +15 g palatable lidocaine gel
    Intervention: Drug: Palatable Lidocaine Topical Gel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2020
Actual Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04213833
Other Study ID Numbers  ICMJE 5788-31-12-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: planned after the completion of the study and publication
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: planned after the completion of the study and publication
Access Criteria: contact of principal investigator
Responsible Party Shereen Elsayed Abd Ellatif, Zagazig University
Study Sponsor  ICMJE Zagazig University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zagazig University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP