Neuraxial block is used in surgery and post operative pain control. Several other drugs are used to prolong the action of the spinal block such as alpha2-agonists, neostigmine, vasoconstrictions.Alpha2-agonists are like as clonidine and dexmedetomidin.Small doses of dexmedetomidin can increase the action of sensory and motor block without hemodynamic effects.in our study 78 patients in ASA1-2 within the ages
of 20-65 who attended hospital for elective orthopaedic surgery in lower limbs at Rasool Akram hospital Tehran, Iran were recruited. Patents were assigned by block randomization in three groups and spinal anesthesia performed in lateral position of L4/L5 space mid line or para median method. First group received 5 micro dexmedetomidin within the volume of 0.5 cc by saline plus 2.5 cc bupivacaine0.5% and second group received 25 micro Fentanyl with 2.5 cc bupivacaine0.5%. Third group received 2.5 cc bupivacaine0.5% plus 0.5cc normal saline.Motor level function was assessed with Modified Bromage method.Time to receive T10 and above anesthesia and 2 dermatom regression and regression to S1 level was determined. Blood pressure and heart rate and SPO2 are measured every minute in first 10 minutes and then every 5 minutes. The patients, study performer and responsible person for collecting data were not aware of drug types.
Comparative addition of Dexmedetomidini and fentanyl to intrathecal bupivacaine in orthopaedic procedure in lower limbs
Public title
Comparative addition of Dexmedetomidini and fentanyl to intrathecal bupivacaine in orthopaedic procedure in lower limbs
Purpose
Treatment
Inclusion/Exclusion criteria
In our study 78 patients in ASA1-2 whit in the ages
of 20-65 that attended hospital for elective orthopaedic surgery in lower limbs at Rasool Akram hospital Tehran, Iran were recruited. Exclusion criteria are: addiction; renal or hepatic failure; disrhythmic heart disease or heart block; allergy to drugs and spinal contraindications such as coagulopathy disorders, injection site infection.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients were divided to three groups. First 26 persons are located in group 1. Second 26 persons are located group 2 and third 26 persons are located in group 3. First group was put on 5 micro dexmedetomidini with2.5 cc bupivacaine 0.5%. Second group put on 25 micro Fentanyl with 2.5 cc bupivacaine 0.5% and third group put on 2.5 cc bupivacaine 0.5% only.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat high way
City
Tehran
Postal code
1449614535
Approval date
2016-04-05, 1395/01/17
Ethics committee reference number
1394.9311174025IR.IUMS.REC
Health conditions studied
1
Description of health condition studied
Regional anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Lenght of sensory block
Timepoint
Sensory level mesured every 2 minutes to higher level then mesured every 10 minutes to regresion of 2 level then every 20 minutes to regresion S1
Method of measurement
Pin prick method in midclavicular linewhith 23 gage needle
2
Description
Lengs of motor block
Timepoint
Time to Bromage 3 and regresion to bromage 0
Method of measurement
Modified bromage
3
Description
Speed of sensory block
Timepoint
Time to T10 and above dermatom
Method of measurement
Pin prick method in midclavicular line whith 23 gage needle
4
Description
Speed of motor block
Timepoint
Time to Bromage 3
Method of measurement
Modified bromage
5
Description
Sensory level
Timepoint
Sensory level mesured every 2 minutes to higher level then mesured every 10 minutes to regresion of 2 level then every 20 minutes to regresion S1
Method of measurement
Upper sensory level with pin prick method in midclavicular linewhith 23 gage needle
Secondary outcomes
1
Description
Blood presure drop
Timepoint
Before and imediatly after injection then every minute to 10 minute and then every 5 minute
Method of measurement
NIBP
2
Description
Heart rate drop
Timepoint
Before and imediatly after injection then every minute to 10 minute and then every 5 minute
Method of measurement
Manitoring system
3
Description
Need to drug
Timepoint
Before and imediatly after injection then every minute to 10 minute and then every 5 minute
Method of measurement
Registrying by anesthetic doctor or technitian
Intervention groups
1
Description
First group was put on 5 micro dexmedetomidini mixed whith normal saline up to 5cc with 2.5 cc bupivacaine 0.5%.
Category
Treatment - Drugs
2
Description
Second group put on 25 micro Fentanyl with 2.5 cc bupivacaine 0.5%
Category
Treatment - Drugs
3
Description
Control group put on 0.5 cc normal saline whith 2.5 cc bupivacaine 0.5%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Saied Amniati
Street address
Rasool Akram Hospital, Niyayesh Ave., Satarkhan
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor of research Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Ali Javad Mousavi
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor of research Iran 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
Iran University of Medical Sciences
Full name of responsible person
Saied Amniati
Position
MD/ resident of anesthesia
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niyayesh Ave., Satarkhan
City
Tehran
Postal code
1445613131
Phone
+98 21 6655 0499
Fax
Email
sa_amniati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Associate Prof of Aanesthesia
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niyayesh Ave., Satarkhan
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Fax
Email
poupak_rah@hotmail.com; p-rahimzadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saied Amniati
Position
MD/ resident of anesthesia
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niyayesh Ave., Satarkhan
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Fax
Email
sa_amniati@yahoo.com; p-rahimzadeh@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)