The Antigagging Effect of Granisetron (Kytril), an Antiemetic Drug, in Dental Situations

NCT00502437 | Unknown

• 1 other identifier: 376-11.05.07HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Antigagging effect of kytril (granisetron) an antiemetic drug in dental situations Gagging in dental situations can be a problem to the patient and the operating dentist. There are not proven methods of eliminating this reflex which sometimes will not allow routine quality dental care. Pharmacological and behavioral approaches to eliminate this reflex have been tried with limited success. This suggested study will test a potent antiemetic drug used in other clinical situations such as antineoplastic treatment. Granisetron is a potential antagonist for the 5-hydroxytryptamine3-receptor - 5HT(3), The drug binds to the receptor and blocks the effect of nausea and vomiting. Kytril mechanism of action was successfully proven for various medical situations as a potential antiemetic agent. Our Center for dental sedation and anesthesia in the oral medicine department have received approval to use Granisetron as an antigagging drug in dental situations based on several pilot studies conducted in other medical centers in different clinical situations such as strabismus corrections, post hysterectomy and others. Our preliminary clinical impression is that pre-emptive IV administration of this drug to patients with increased gag reflex is beneficial. In our research we try to investigate the possibility of using kytril in dental situations. In the first stage of this research we will study the INTRAVENOUS use of this drug and its effects On normal subjects compare them to themselves with placebo. According to the results of this study we will go on to the second stage of the research and try the same drug under oral administration. The purpose of this study is to test the antigagging effect of this drug in a controlled manner in dental situations. Our working hypothesis is that administration of this drug in dental situations with success, will allow many patients to receive good dental care

Conditions

Antiggaging Effect; Antiemetic; Granisetron; Gag Reflex; Dental Situations

Interventions

GRANISETRON DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• normal subjects

You may not qualify if:

• presence of systemic disease
• subjects under medication or drug or food complementary agents

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Gagging

Interventions

Granisetron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Eliezer Kaufman, DMD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliezer Kaufman, Professor

CONTACT

+972.2.6776121; ekaufman@cc.huji.ac.il

Silvina Friedlander-Barenboim, DMD

CONTACT

+972.2.6776157; silvina@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: DOUBLE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 17, 2007
• Last Updated: November 30, 2010

Record last verified: 2007-06

Locations

IL (1)