Overall 105 patients who are candidate for upper endoscopy included and divided randomly to two groups: 53 people as group A (placebo) and 52 person as group B (midazolam). In group A 5CC water and in group B, 5mg midazolam diluted in equal volume of distilled water sprayed intranasal. After 45 minutes, upper endoscopy was done under monitoring and according check list duration, gag reflex, pulse rate, SPO2, amnesia and satisfaction was recorded and the DATA of two groups would be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110087740N1
Registration date:2013-04-22, 1392/02/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-22, 1392/02/02
Registrant information
Name
Ahmad kadkhodae
Name of organization / entity
Ahwaz jondyshapur univercity
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 1417
Email address
kadkhodae-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences and Health Serrvices
Expected recruitment start date
2010-10-10, 1389/07/18
Expected recruitment end date
2011-04-10, 1390/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intranazal midazolam efficacy in upper endoscopy
Public title
Midazolam sedation in endoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterion: patients aged between 20 to 60 years old candidate for upper endoscopy.
Exclusion criteria:GIB; COPD; CHF and intolerance to upper endoscopy.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz University of Medical sciences and Health Services of Ethic commite
Street address
Ahvaz University of Medical Sciences and Health services
City
Ahvaz
Postal code
Approval date
2011-05-30, 1390/03/09
Ethics committee reference number
231-اچ تی ای
Health conditions studied
1
Description of health condition studied
Upper endoscopy
ICD-10 code
K31-9
ICD-10 code description
Upper endoscopy for evaluation of upper GI diseases
Primary outcomes
1
Description
Midazolam sedation for making upper endoscopy more comfort
Timepoint
2 hours after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Amnesia after endoscopy
Timepoint
2 hours after endoscoy
Method of measurement
Questionnaire
Intervention groups
1
Description
Intranazal midazolam 1mg in intervention group and pure water in control.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endoscopy ward, Emam hospital
Full name of responsible person
Kadkhodae
Street address
Ahvaz Emam hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences and Health Services
Full name of responsible person
Ali Mard
Street address
Ahvaz- Kooye Ostadan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences and Health Services
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
Name of organization / entity
Ahvaz University of Medical Sciences and Health Services
Full name of responsible person
Hajiani Eskandar
Position
Gastroentrologist
Other areas of specialty/work
Street address
Number 1, Kkianpars, Ahvaz
City
Ahvaz
Postal code
Phone
+98 611222292
Fax
Email
eskandarhajiani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences and Health Srcices
Full name of responsible person
Hajiani Eskandar
Position
Gastroenterologist
Other areas of specialty/work
Street address
Numbe 1, Kianpars, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1222 2922
Fax
Email
eskandarhajiani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences and Health Services
Full name of responsible person
Hajiani Eskandar
Position
Gastroenterologist
Other areas of specialty/work
Street address
Number1, Kianpars, Ahvaz
City
Ahvaz
Postal code
Phone
+98 611222292
Fax
Email
eskandarhajiani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)