Comparative evaluation of partial saturation of peripheral blood in two intravenous sedation methods (Midazolam+fentanyl) & ( midazolam+ketamine) for implant surgery
In this double blind prospective clinical trial two groups of patients in total number of 73 who refered for 2-3 implant in mandible to operating room of Isfahan dental school, were studied. In one group combination of midazolam/fentanyl and in second group midazolam/ketamine was prescribed. SPO2 was measured in 6 stages.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008314224N6
Registration date:2011-01-27, 1389/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-27, 1389/11/07
Registrant information
Name
Nasser Kaviani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2858
Email address
kaviani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Isfahan faculty of dentistry
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-05-22, 1389/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of partial saturation of peripheral blood in two intravenous sedation methods (Midazolam+fentanyl) & ( midazolam+ketamine) for implant surgery
Public title
Comparative evaluation of partial saturation of peripheral blood in two intravenous sedation methods (Midazolam+fentanyl) & ( midazolam+ketamine) for implant surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1-beind older than 18
2- patient do not use drugs
3-patients do not have heart respiratory or CNS disease
4-satisfaction to be case of study.
Exclusion criteria
1-Need to more than 90 min for surgery
2-surgical complication
3-need to inject more than 4.8 ml lidocain for local anesthesia
Age
From 18 years old to 88 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
73
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research of Isfahan faculty of dentistry
Street address
Shohadaye sofe street
City
Isfahan
Postal code
Approval date
2009-07-13, 1388/04/22
Ethics committee reference number
388187
Health conditions studied
1
Description of health condition studied
Partial Saturation of peripheral blood
ICD-10 code
T78.8
ICD-10 code description
Other adverse effects, not elsewhere classified
Primary outcomes
1
Description
Partial Saturation of peripheral blood
Timepoint
before and 5 & 10 & 20 & 40 minutes after drug injection
Method of measurement
observation and examination
Secondary outcomes
1
Description
Hypoxia & sometimes sizure
Timepoint
Continuous
Method of measurement
Observation & Examination
Intervention groups
1
Description
In one group combination of midazolam/fentanyl(1mg midazolam & 25micro gram fentanyl so 1mg midazolam every 2 minutes until being conscious sedated) so 1mg midazolam every 2 minutes until being conscious sedated).
Category
Treatment - Drugs
2
Description
In second group midazolam/ketamine was prescribed(1mg midazolam & 20mg ketamine so 1mg midazolam every 2 minutes until being conscious sedated).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan faculty of dentistry
Full name of responsible person
Dr Naser Kaviani
Street address
Shohadaye sofe street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Isfahan faculty of dentistry
Full name of responsible person
Aminallah Tavangar
Street address
Shohadaye sofe street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Isfahan faculty of dentistry
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of dentistry
Full name of responsible person
Dr Naser Kaviani
Position
Anesthesiologist
Other areas of specialty/work
Street address
Faculty of dentistry, Shohadaye sofe street
City
Isfahan
Postal code
Phone
+98 31 1792 2858
Fax
Email
kaviani@dnt.mui.ac.ir , kavianidoctor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of dentistry
Full name of responsible person
Mehdi Aminzadeh
Position
Dentistry student
Other areas of specialty/work
Street address
Dental school, Shohadaye sofe street
City
Isfahan
Postal code
Phone
Fax
Email
aminzadehmehdi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)