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The Antigagging Effect of Granisetron (Kytril), an Antiemetic Drug, in Dental Situations
This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, June 2007
First Received: July 16, 2007   No Changes Posted
Sponsor: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00502437
  Purpose

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


Condition Intervention
Antiggaging Effect
Antiemetic
Granisetron
Gag Reflex
Dental Situations
Drug: GRANISETRON

Study Type: Interventional
Study Design: Double-Blind, Placebo Control, Crossover Assignment

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal subjects

Exclusion Criteria:

  • presence of systemic disease
  • subjects under medication or drug or food complementary agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502437

Contacts
Contact: Eliezer Kaufman, Professor +972.2.6776121 ekaufman@cc.huji.ac.il
Contact: Silvina Friedlander-Barenboim, DMD +972.2.6776157 silvina@hadassah.org.il

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Eliezer Kaufman, DMD Hadassah Medical Organization
  More Information

No publications provided

Study ID Numbers: 376-11.05.07HMO-CTIL
Study First Received: July 16, 2007
Last Updated: July 16, 2007
ClinicalTrials.gov Identifier: NCT00502437     History of Changes
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Pharmacologic Actions
Signs and Symptoms
Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Gagging
Granisetron
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009