Many patients prefer to be sedated and amnesic during surgical procedures. We investigated the effective and safe dose of intravenous midazolam for sedation and amnesia during general anesthesia in patients undergoing outpatient surgical procedure. 92 patients aged 20–60 years scheduled for general anesthesia received midazolam 1 or 3 mg intravenously 5min before entering the operating room. Premedication was performed with fentanyl 2 microrgram/kg. General anesthesia was performed with 4 mg/kg sodium thiopntal . Blood pressure, heart rate, respiratory rate, percutaneous oxygen saturation (SpO2), were measured every 5min for 30min. Memory during surgery was also investigated by recall of poster and events.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101293468N5
Registration date:2011-04-04, 1390/01/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-04, 1390/01/15
Registrant information
Name
Mohammad Reza Hajiesmaeili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00983516227747-00983517232422
Email address
hajiesmaeili@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences and Health Services
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of different doses of midazolam for amnesia and sedation in general anesthesia
Public title
Evaluation of different doses of midazolam for amnesia and sedation in general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1- ASA Class=1,2; 2- Elective outpatient surgical procedure under general anesthesia; 3- age below 60 years; 4- weight between 50-100 kilogram; 5- No visual disturbance; 6- No auditory disturbance; 7- No memory disturbance; 8- No tranqulizer drug consumption. Exclusion criteria: known allergy to study drug.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Shahid Sadoughi University of Medical Science and Health Services
Street address
Shhid Bahonar Square
City
Yazd
Postal code
Approval date
2008-09-23, 1387/07/02
Ethics committee reference number
1064
Health conditions studied
1
Description of health condition studied
amnesia
ICD-10 code
F44.0
ICD-10 code description
Dissociative amnesia
Primary outcomes
1
Description
amnesia
Timepoint
after 4 hours
Method of measurement
events and poster recall
Secondary outcomes
empty
Intervention groups
1
Description
in group 1 patiens were received intravenous midazolam 1 milligram just before entering to the operating room.
Category
Prevention
2
Description
in group 2, patients were given 3 milligram intravenously just before entering to the operating room.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Shekoufeh Behdad
Street address
Shahid Sadoughi hospital , Safaieeh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Hassan Mozaffari Khosravi
Street address
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Reza Hajiesmaeili
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Rahnemoon hospital
City
Yazd
Postal code
8919895746
Phone
+98 35 1626 9979
Fax
+98 35 1822 4100
Email
hajiesmaeili@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science and Health Services
Full name of responsible person
Shekoufeh Behdad
Position
Anesthesiologisy assistant professor
Other areas of specialty/work
Street address
Shahid Sadoughi hospital
City
Yazd
Postal code
Phone
+98 35 1822 1386
Fax
+98 35 1822 4100
Email
drbehdad@yahoo.com , hajiesmaeili@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science and Health Services
Full name of responsible person
Mohammd Reza Hajiesmaeili
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Rahnemoon hospital
City
Yazd
Postal code
8919895746
Phone
+98 35 1625 8722
Fax
+98 35 1822 4100
Email
hajiesmaeili@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)