Study purpose: Evaluation of the effect of intrathecal midazolam on block characteristic and control of postoperative pain in orthopedic surgery undergoing spinal anesthesia with bupivacaine.
Design: randomized, double blind controlled with placebo.
Inclusion criteria: taking Informed consent to enter the study; patients between 20-70 old age; ASA Physical status class 1 and 2.
Exclusion criteria: Ischemic heart disease; hypertension; uncontrolled diabetes; valvular heart disease; coagulopathy; lumbar spinal column deformity; block failure due to technical problems; needs to extra sedative drugs.
Sample size: 80 person.
Intervention: Spinal anesthesia will be applied with 17.5 mg bupivacaine 0.5% in 3.5 ml plus 2.5 mg midazolam in 0.5 ml (total volume 4 ml) in study group, and 17.5 mg bupivacaine 0.5% in 3.5 ml plus 0.5 ml normal salin (total volume 4 ml) in control group.
Main outcome measures: Level of sensory block using cold cotton will be measured every one minute and whenever the same results will be gained in the four consecutive measurements, the detected dermatom will be recorded as the peak snsory block level. At the end of the surgery,when the patient is transferred to post anesthesia care unit (PACU) motor block will be measured and recorded using modified bromage scale. Time of regressing sensory block to the level of S1 dermatom, and regressing motor block to the bromage scale of 1, will be recorded and then the patients will be discharged from PACU.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016063028712N1
Registration date:2017-01-06, 1395/10/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-06, 1395/10/17
Registrant information
Name
Razieh Ebrahimi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3182 7317
Email address
r.ebrahimi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparison of addition of Midazolam or Normal Saline to Bupivacaine in spinal anesthesia in patients with fracture of lower extremities
Public title
Effects of intrathecal midazolam on block characteristic and control of postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1) take Informed consent to enter the study; 2) patients between 20-70 old age; 3) Physical status 1 and 2 classification of "American Society of Anesthesiologists"(ASA).
Exclusion criteria: 1) Ischemic heart disease; 2) Hypertension; 3) Uncontrolled diabetes; 4) Valvular heart disease; 5) Coagulopathy; 6) Lumbar spinal column deformity; 7) Block failure due to technical problems; 8) Needs to extra sedative drugs.
Age
From 20 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Computer generated randomization
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences , Pasdaran street, sanandaj
City
Sanandaj
Postal code
661777-13446
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
muk.rec.1395.82
Health conditions studied
1
Description of health condition studied
Regional anesthesia
ICD-10 code
T41.3
ICD-10 code description
Local anesthetics
Primary outcomes
1
Description
Intensity of sensory block
Timepoint
During first ten minute after block
Method of measurement
Cold cotton
2
Description
Intensity of motor block
Timepoint
During first ten minute after block
Method of measurement
Bromage scale
3
Description
Duration of sensory block
Timepoint
The time to regresion of sensory block to S1 in PACU
Method of measurement
Cold cotton
4
Description
Duration of motor block
Timepoint
The time to regression of motor block to bromage 1 in PACU
Method of measurement
Bromage scale
Secondary outcomes
1
Description
Pain scale
Timepoint
In discharge time and three houre later
Method of measurement
Numerical rating scale
2
Description
Nausea and vomiting
Timepoint
Time of block until discharge from recovery(PACU)
Method of measurement
Questionnaire
3
Description
Shivering
Timepoint
Time of block until discharge from recovery(PACU)
Method of measurement
Observation of face and extermitis
4
Description
Hypotension
Timepoint
First 15 minute after block every 2 minute and then every 15 minute
Method of measurement
Monitoring
5
Description
Bradycardia
Timepoint
First 15 minute after block every 2 minute and then every 15 minute
Method of measurement
Monitoring
6
Description
The time to first analgesic request
Timepoint
3 houre after discharge of recovery
Method of measurement
File
Intervention groups
1
Description
Intervention group: Spinal anesthesia will be done with 17.5 mg bupivacain 0.5% in 3.5 ml plus 2/5 mg midazolam in 0.5 ml (total volume 4 ml) in study group
Category
Treatment - Drugs
2
Description
Control group: Spinal anesthesia will be done with 17.5 mg bupivacain 0.5% in 3.5 ml plus 0.5 ml normal salin (total volume 4 ml) in control group .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Be'sat hospital of Sanandaj
Full name of responsible person
Dr.Farzad Sarshivi
Street address
Be'sat hospital, Keshavarz street, Sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Kurdistan University of Medical Sciences
Full name of responsible person
Dr.Ebrahim Ghaderi
Street address
Kurdistan University of Medical Sciences, Pasdaran street, Sanandaj
City
Sanandaj
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 Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Dr.Farzad Sarshivi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, Pasdaran street, Sanandaj
City
Sanandaj
Postal code
Phone
+98 87 3366 4645
Fax
Email
farzadsarshivi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr.Karim Naseri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, Pasdaran street, Sanandaj
City
Sanandaj
Postal code
Phone
+98 87 3366 4645
Fax
Email
bihoshi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Razie Ebrahimi
Position
Medical student
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, Pasdaran street, Sanandaj
City
Sanandaj
Postal code
661777-134446
Phone
+98 87 3366 4645
Fax
+98 33664645
Email
r.ebrahimi@muk.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)