Intraoperative awareness and understanding are of the unpleasant complications of anesthesia which are essential to reduce due to psycho-physiological . This study was done to investigate the effects of Midazolam for reducing the complication occurs during the surgery. This study was done on patients admitted for elective surgery, general surgery, urology - orthopedic surgery with a length of about one hour in class 1 and 2 ASA classification .Patients with hearing problems, psychiatric illness, drug addiction and using drugs affecting the nervous and mental who were referred to ICU after operation because of specific condition will be excluded from study. Anesthesia technicians and the intern were unaware of members of the both groups. The patients were randomly assigned into two groups of intervention and control. 2.5 mg of Midazolam was injected to intervention group about 15 minutes before induction of anesthesia. Both groups were induced by 5mg/kg of Thiopental and 1.5mg/kg of intravenous Midazolam and then were anesthetized pre-oxygenation. The anesthesia continued using Halothane 0.5% and N2o and Oxygen in proportion of 50%. Muscle relaxation is done using Atracurium 2/0 .During surgery, blood pressure, heart rate, tearing and requiring of sedative increasing depth of anesthesia will be examined. After the surgery the patient's intelligence, and 1 hour after surgery, pain and touch and hearing the conversation during the act, dream act in time, recalling memories were recorded in the questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207086480N3
Registration date:2012-08-10, 1391/05/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-10, 1391/05/20
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellory for research, Shahrekord University of Medical Sciences
Expected recruitment start date
2012-07-13, 1391/04/23
Expected recruitment end date
2012-11-06, 1391/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Midazolam on perception and consciousness during surgery
Public title
Effect of Midazolam on perception and consciousness during surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients who are candidate for elective surgery class A, Two ASA classification, 1 hour for operation length, the age ranges between 15-45 years old. Exclusion criteria: having every kind of hearing problems, neurological disease, addiction, using drugs affective for Psychiatry and patients who are referred to ICU after operation because of specific condition.
Age
From 15 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
154
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Kashani Boulevard
City
Sahrekord
Postal code
Approval date
2007-10-15, 1386/07/23
Ethics committee reference number
7-7-86
Health conditions studied
1
Description of health condition studied
Intraoperative awareness
ICD-10 code
R41
ICD-10 code description
Other symptoms and signs involving cognitive functions and awareness
Primary outcomes
1
Description
Increasing depth of anesthesia
Timepoint
Intraoperation
Method of measurement
Questionnaire
2
Description
Recalling the memories
Timepoint
1 hour after operation
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Tearing
Timepoint
Intraoperation
Method of measurement
Questionnaire
2
Description
Tachycardia
Timepoint
Intraoperation
Method of measurement
Questionnaire
3
Description
Dream in action
Timepoint
1 hour after operation
Method of measurement
Questionnaire
4
Description
Hearing the conversation intraoperation
Timepoint
1 hour after operation
Method of measurement
Questionnaire
5
Description
pain
Timepoint
1 hour after operation
Method of measurement
Questionnaire
Intervention groups
1
Description
The intervention group receive 2.5 mg intravenous Midazolam 15 minutes before induction of anesthesia. After the pre-oxygenation they are placed under anesthesia with the 5 mg / kg of Thiopental and 1.5 mg/kg of Succinylcholine induction, continuation of anesthesia is done using Halothane 0.5% and N2o and oxygen in proportion of 50%. Muscle relaxation by Atracurium 2/0 is created.
Category
Other
2
Description
In the control group after pre-oxygenation they are placed under anesthesia induction with the 5 mg / kg of thiopental and 1.5 mg/ kg of Succinylcholine, continuation of anesthesia is done using Halothane 0.5% and N2o and oxygen in proportion of 50%. Muscle relaxation created by Atracurium 2/0 .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord ayatollah Kashani hospital
Full name of responsible person
Dr Ebrahim Pouria Monfared
Street address
Shariati Street
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellory for research, Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmoud Mobasheri
Street address
Kashani boulevard
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellory for research, Shahrekord University of Medical Sciences
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
Ayatollah Kashani hospital
Full name of responsible person
Dr Ebrahim Pouria Monfared
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shariati Street
City
Shahrekord
Postal code
Phone
+98 38 1226 4825
Fax
Email
forouzanganji@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ayatollah Kashani hospital
Full name of responsible person
Dr Ebrahim Pouria Monfared
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shariati Street
City
Shahrekord
Postal code
Phone
+98 38 1226 4825
Fax
Email
forouzanganji@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)