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

August 5, 2020 updated by: Shereen Elsayed Abd Ellatif, Zagazig University

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

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elsharqya
      • Zagazig, Elsharqya, Egypt, 44519
        • Faculty of medicine, Zagazig university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: group I (control group)
patients will receive propofol 50 mg
Drug: Propofol Injection [Diprivan]
patients will be sedated with 50 mg propofol(10 mg/ml) given slowly intravenously over 1 min
Active Comparator: group II
patients will receive propofol 50 mg + dexmedetomidine 0.5 mcg/ kg
Drug: Dexmedetomidine [Precedex]
patients will received 0.5 mcg/ kg dexmedetomidine intravenously followed by syringe containing 50 mg propofol(10 mg/ml).
Other Names:
  • propofol
Active Comparator: group III
patients will receive propofol 50 mg +15 g palatable lidocaine gel
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 Names:
  • propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through endoscopic procedure up to one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every 2 min for the first 10 min of the procedure, then every 5 min till the end of the procedure.
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
every 2 min for the first 10 min of the procedure, then every 5 min till the end of the procedure.
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)
2 hours post the procedure
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)
through endoscopic procedure up to one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

December 23, 2019

First Submitted That Met QC Criteria

December 27, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5788-31-12-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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