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

NCT04213833 | Completed

• 1 other identifier: 5788-31-12-2019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-Intestinal Disorder

Keywords

palatable lidocaine; dexmedetomidine; gag reflex; gastrointestinal endoscopy

Outcome Measures

Primary Outcomes (1)

• Gag reflex

  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 Outcomes (4)

• heart rate

  every 2 min for the first 10 min of the procedure, then every 5 min till the end of the procedure.

• mean blood pressure

  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)

  2 hours post the procedure

• Endoscopist's satisfaction regarding gagging and difficulty of performing the procedure

  through endoscopic procedure up to one hour

Study Arms (3)

group I (control group)

PLACEBO COMPARATOR

patients will receive propofol 50 mg

Drug: Propofol Injection [Diprivan]

group II

ACTIVE COMPARATOR

patients will receive propofol 50 mg + dexmedetomidine 0.5 mcg/ kg

Drug: Dexmedetomidine [Precedex]

group III

ACTIVE COMPARATOR

patients will receive propofol 50 mg +15 g palatable lidocaine gel

Drug: Palatable Lidocaine Topical Gel

Interventions

Propofol Injection [Diprivan] DRUG

patients will be sedated with 50 mg propofol(10 mg/ml) given slowly intravenously over 1 min

group I (control group)

Dexmedetomidine [Precedex] DRUG

patients will received 0.5 mcg/ kg dexmedetomidine intravenously followed by syringe containing 50 mg propofol(10 mg/ml).

Also known as: propofol

group II

Palatable Lidocaine Topical Gel DRUG

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.

Also known as: propofol

group III

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, zagazig university

Zagazig, Elsharqya, 44519, Egypt

Location

Related Publications (6)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 4835444 BACKGROUND

• 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.

  PMID: 15153854 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22000794 RESULT

MeSH Terms

Conditions

Digestive System Diseases; Gagging

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participant and endoscopist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 30, 2019
• Study Start: January 1, 2020
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: planned after the completion of the study and publication
• Access Criteria: contact of principal investigator

Locations

EG (1)