Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502437
Status:
UNKNOWN
Last Update Posted:
2010-11-30
First Post:
2007-07-16
Brief Title:
The Antigagging Effect of Granisetron Kytril an Antiemetic Drug in Dental Situations
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 - 5HT3 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
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 - 5HT3 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None