Protocol summary

Summary
Objective: Evaluation of effect of intrathecal co-administration of dexmedetomidine and bupivacaine on spinal anesthesia blocks characteristics in patient undergoing elective caesarean section . Setting : In this prospective randomized double blind clinical trail 50 patients who will scheduled for cesarean section under spinal anesthesia in besat hospital of sanandaj will be randomly divided in to 2 equal 25 patient group . Inclusion criteria: writing consent form, American Society of Anesthesiologist physical status 1 or 2. Exclusion criteria: preeclampsia or eclampsia, diabetes mellitus, chronic hypertension, cardiovascular disease, renal disease, hepatic failure, and known allergy to study drugs. Method: After insertion of two G20 venous catheters in dorsum of patient’s hands 10 Ml/Kg normal saline will be infused to patients. Standard monitoring will be start for patient and basic values will be record. Spinal anesthesia will be done in sitting position via L3-L4 or L4-L5 space using disposable (G=26) needle. Following spinal anesthesia patient immediately turned to supine position and about 5 degree head down. Intervention: induction of spinal anesthesia will be done by using 12.5 mg bupivacaine plus 5 mic dexmedetomidine in study group, and the same value of bupivacaine plus 0.5 ml 0.9% normal saline in control group (volume of drug will be reached to 3 ml by adding stilled water in both group). Primary outcome: peak of sensory block and the needing time to reach that, the needing time to reach motor block to highest degree of modified bromage scale, time of regression of sensory block to level of S1 and regression of motor block to modified bromage scale 1. Secondary outcome: cardiovascular change during first 30 min of anesthesia, and complication of block. Blinding: patient, anesthesiologist who do spinal anesthesia, and the anesthesiologist who evaluate study outcomes are unaware about patients grouping .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201512051766N8
Registration date: 2016-01-20, 1394/10/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-20, 1394/10/30
Registrant information
Name
Karim Nasseri
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 3728
Email address
nasseri_k@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences .Vice chancellor for research
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intrathecal dexmedetomidine effect on block characteristics during spinal anesthesia for cesarean section
Public title
Evaluation of intrathecal dexmedetomidine effect on block characteristics during spinal anesthesia for cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : American Society of Anesthesiologist Physical status 1 or 2 Exclusion criteria : Any absolute or relative contraindication for spinal anesthesia ; BMI > 25 ; history of taking α2 antagonist drugs ; history of hypertension or antihypertensive drug taking ; history of heart disease (ischemic ,valular ,blocks) ; renal failure ; hepatic disease ; history of allergy to study drugs ; inadequate spinal block level
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences ethic committee
Street address
Pardis of medicien faculty , Pasdaran BLV
City
Sanandaj
Postal code
Approval date
2015-08-15, 1394/05/24
Ethics committee reference number
MUK.REC.1394.141

Health conditions studied

1

Description of health condition studied
spinal anesthesia
ICD-10 code
Other comp
ICD-10 code description
O29.8

Primary outcomes

1

Description
peak of sensory block
Timepoint
every 15 min until reaching equal result inthree consecutive session
Method of measurement
using Cotton alcohol method in midclavicular line from distal to proximal of body

2

Description
needing time to reach the peak of sensory block
Timepoint
every 2 min until reaching equal result in three consecutive session
Method of measurement
using Cotton alcohol method in midclavicular line from distal to proximal of body

3

Description
needing time to reach motor block to highest degree
Timepoint
every 15 min
Method of measurement
modified bromage scale

4

Description
time of regression of sensory block
Timepoint
every 15 min in post anesthesia care unit
Method of measurement
time need to regression of sensory block to level of S1 using

5

Description
time need to regression of motor block
Timepoint
every 15 min in post anesthesia care unit
Method of measurement
based on modified bromage scale

Secondary outcomes

1

Description
cardiovascular chang
Timepoint
every 10 min
Method of measurement
Using indirect blood pressure measurement via automated devise

Intervention groups

1

Description
Intervention : 12.5 Mg bupivacaine 0.5% plus 5 mic dexmeditomidine (total volume 3 Ml by adding distilled water)
Category
Treatment - Drugs

2

Description
Control : 12.5 Mg bupivacaine 0.5% plus 0.5 Ml 0.9% normal saline (total volume 3 Ml)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
operating room number2, Besat Hospital
Full name of responsible person
Dr.KarimNasseri
Street address
Besat hospital , Keshavarz Street
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences .Vice chancellor for research
Full name of responsible person
Ebrahim Ghaderi
Street address
Pardis of University
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan University of Medical Sciences .Vice chancellor for research
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
Sanandaj Faculty of Medicine
Full name of responsible person
Dr.Ebrahim Ghaderi
Position
Epidemiologist / Head of research concil of KUMS
Other areas of specialty/work
Street address
Pardis of University, Pasdaran BLV
City
Sanandaj
Postal code
Phone
+98 87 3366 6473
Fax
Email
ebrahimghaderi@muk.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Anesthesiokogy , Kurdistan University of Medicak Sciences
Full name of responsible person
Dr. Karim Nasseri
Position
Associate Professor / Anesthesiologist
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz Street
City
Sanandaj
Postal code
Phone
00
Fax
Email
nasseri_k@muk.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj Faculty of Medicine
Full name of responsible person
Dr. Karim Nasseri
Position
Anesthesiologist / Department of Anesthesiology
Other areas of specialty/work
Street address
Besat Hospital , Keshavarz Street
City
Sanandaj
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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