This randomized double blind controlled trial was conducted to investigate the effects of co-administration of clonidine and pethdine with bupivacaine during spinal anesthesia. Fifty patients, in class 1 or 2 ASA, candidates for surgery on lower limbs, were randomly allocated in two groups and received either spinal anesthesia with combination of Clonidine 0.75 µgr/kg and Pethidine 0.75 mg/kg) or spinal anesthesia with Bupivacaine 0.5%, 15 mg. Systolic blood pressure, heart rate, level of sensory block, motor block, and sedation rate were measured every 2 minutes at the first 10 minutes, every 3 minutes at the next 10 minutes, and every 5 minutes for the next 160 minutes. Analgesic requests were also recorded every 1 hour for 24 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903013991N1
Registration date:2009-03-21, 1388/01/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-03-21, 1388/01/01
Registrant information
Name
Reza Salmanian
Name of organization / entity
Iran university of medical siences
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 5234
Email address
salmanian@irimc.org
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of co-administration of clonidine and pethdine with bupivacaine during spinal anesthesia
Public title
Comparison of co-administration of clonidine and pethdine with bupivacaine during spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients in class I or II ASA are selected for surgery in lower limbs at Rasoule akram Hospital.
Exclusion criteria: Any known contraindication for spinal anesthesia, such as increased intracranial pressure, neurological disorders, hemorrhagic diathesis, or infection at the puncture site, disorientation, bilateral lower limb Fx., pelvic Fx., diabetes mellitus, miteral stenosis, aortic stenosis, allergy to bupivacaine or clonidine or pethidine.
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemmat Expway, Iran University of Medical Sciences
City
Tehran
Postal code
Approval date
2009-02-21, 1387/12/03
Ethics committee reference number
4399
Health conditions studied
1
Description of health condition studied
Spinal anesthesia
ICD-10 code
Y48.4
ICD-10 code description
Anaesthetic, unspecified
Primary outcomes
1
Description
Systolic Blood Pressure
Timepoint
First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes
Method of measurement
With automatic BP indicator
2
Description
Level of sensory block
Timepoint
First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes
Method of measurement
Evaluation for level of sensory block at different dermatome with blunt needle fo e
3
Description
Motor Block
Timepoint
First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes
Method of measurement
1=unable to move hip, 2=unable to move knee and 3=unable to move foot
4
Description
Sedation rate
Timepoint
First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes
Method of measurement
0=anxiet, 1=awake and calm, 2=Sleepy, 3=Sleepy and responsive to sound, 4=Sleepy and responsive to painfull stimuli, 5=Unresponsive
5
Description
Heart rate
Timepoint
First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes
Method of measurement
ECG monitoirg
6
Description
Analgesic request
Timepoint
Every 1 hour for 24 hours
Method of measurement
Patient's request
Secondary outcomes
1
Description
Vomitting
Timepoint
First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes
Method of measurement
Observation
2
Description
Bradicardia
Timepoint
First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes
Method of measurement
ECG monitoirg
3
Description
Nausea
Timepoint
First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes
Method of measurement
Observation
4
Description
Hypotension
Timepoint
First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes
Method of measurement
Observation on Monitoring of Blood pressur indicator
Intervention groups
1
Description
Spinal anesthesia with 15 mg Bupivacaine 0.5%
Category
Treatment - Drugs
2
Description
Spinal anesthesia with 0.75 mg/kg pethidine + 0.75 microgram/kg clonidine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoule akram Hospital
Full name of responsible person
Reza Salmanian (Anesthesia resident)
Street address
Satarkhan ave. Niayesh st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Farnad Imani
Street address
Niayesh st., Satarkhan Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?