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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00502437
First received: July 16, 2007
Last updated: November 28, 2010
Last verified: June 2007
  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: Intervention Model: Crossover Assignment
Masking: Double-Blind

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Eliezer Kaufman, DMD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Eliezer Kaufman, DMD Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00502437     History of Changes
Other Study ID Numbers: 376-11.05.07HMO-CTIL
Study First Received: July 16, 2007
Last Updated: November 28, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on August 21, 2014