The effect of Bupivacaine alone compared to Bupivacaine with Dexmedetomidine on patients' hemodynamic in orthopedic surgery of upper limb in Shariati Hospital in 95-96
(1) Objectives: Compare hemodynamic changes in studied patients.
(2) Design: Randomized, Double blinded, Controlled with Placebo, One center, 2-3 Trial phase.
(3) Setting and conduct: Two groups of 49 people (98 totally) that supraclavicular block is applied on them based on sonography guidance. Through interviews with patients, demographic information and pain scores collected. Information on the onset and duration of sensory and motor block was obtained by Pinprick Test and Lovett Rating Scale. Hemodynamic data was extracted from the monitoring device.
(4) Participants including major eligibility criteria: Major inclusion criteria: age 20-50 year-old; American Society of Anesthesiologists class I,II; Body Mass Index less than 35. Major exclusion criteria: Failed to supraclavicular block; Prolonged surgery more than 180 minutes; Liver Disease; Diabetes Mellitus; Hypertension; taking Blood pressure medication.
(5) Intervention: In intervention group 30 milliliters of 5 percent Bupivacaine and 20 micro grams of Dexmedetomidine; and in controlled group 30 milliliters of 5 percent Bupivacaine and 0.2 milliliters Normal Saline (as placebo) for supraclavicular block will be used.
(6) Main outcome measures (variables): The numerical values of the Mean Arterial Pressure (as a primary out come), Heart Rate per minute, the Arterial Oxygen Saturation, Respiratory Rate per minute, Sensory and Motor block Onset and Duration of Sensory and Motor block (as secondary outcomes) in the two groups are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112631108N1
Registration date:2017-03-04, 1395/12/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-04, 1395/12/14
Registrant information
Name
Siamak Yoosefi Khanghah
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6696
Email address
s-yoosefi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences Vice Chancellor of Research
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Bupivacaine alone compared to Bupivacaine with Dexmedetomidine on patients' hemodynamic in orthopedic surgery of upper limb in Shariati Hospital in 95-96
Public title
The effect of Bupivacaine with and without Dexmedetomidine on patients' hemodynamic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:20-50 year old; Body Mass Index less than 35; American Society of Anesthesiologists class I,II; No Allergic drug history; Patient satisfaction and fill out the consent form
Exclusion Criteria: Failed to supraclavicular block; Prolonged surgery more than 180 minutes; Cancel patients; Liver Disease; Diabetes Mellitus; Hypertension; taking Blood pressure medication; taking beta blocker medication; The incidence of surgical complication during surgery; Requires general anesthesia
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
98
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
Research Ethics Committee of the Medical Faculty of Tehran University of Medical Sciences
Street address
Professional Doctoral Theses Unit, Ground Floor, Education Building, Faculty of Medicine, Tehran University of Medical Sciences, Pour Sina Street, District 6, Tehran
City
Tehran
Postal code
Approval date
2017-01-29, 1395/11/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1566 1395/11/10
Health conditions studied
1
Description of health condition studied
Regional Anesthesia
ICD-10 code
y48.3
ICD-10 code description
Local Anesthetics
Primary outcomes
1
Description
Mean Arterial Pressure
Timepoint
In recovery (base line) then every 5 minutes after block, then every 5 minutes after starting surgery for 30 minutes, then every 15 minutes till end of surgery and in Departure time from recovery
Method of measurement
Millimeter Hg (Mercury) by non-invasive Manometer device
Secondary outcomes
1
Description
Heart Rate per minute
Timepoint
In recovery (base line) then every 5 minutes after block, then every 5 minutes after starting surgery for 30 minutes, then every 15 minutes till end of surgery and in Departure time from recovery
Method of measurement
Cardiac Monitoring Device
2
Description
Respiratory Rate per minute
Timepoint
In recovery (base line) then every 5 minutes after block, then every 5 minutes after starting surgery for 30 minutes, then every 15 minutes till end of surgery and in Departure time from recovery
Method of measurement
Monitoring Device
3
Description
Arterial Oxygen Saturation
Timepoint
In recovery (base line) then every 5 minutes after block, then every 5 minutes after starting surgery for 30 minutes, then every 15 minutes till end of surgery and in Departure time from recovery
Method of measurement
Continious Pulse Oximetry
4
Description
Narcotics received in 24 hours
Timepoint
Total drug intake in first 24 hours after surgery
Method of measurement
Patient's file
5
Description
Time to First Analgesic Request
Timepoint
Time to first analgesic request
Method of measurement
Patient's file
6
Description
Onset of Sensory Block
Timepoint
5-10-15 -30 minute intervals after injection
Method of measurement
Physical Examination by Physician (Pinprick test)
7
Description
Onset of Motor Block
Timepoint
5-10-15 -30 minute intervals after injection
Method of measurement
Physical Examination by Physician (Lovett Rating Scale)
8
Description
Duration of Sensory Block
Timepoint
Every 10 minutes after full sensory block until complete return of sensation
Method of measurement
Physical Examination by Physician (Pinprick test)
9
Description
Duration of Motor Block
Timepoint
Every 10 minutes after full motor block until complete return of motor function
Method of measurement
Physical Examination by Physician (Lovett Rating Scale)
Intervention groups
1
Description
Supraclavicular injection of 30 milliliter 0.5 percent Bupivacaine + 20 microgram Dexmedetomidine solution with ultrasound guidance
Category
Treatment - Drugs
2
Description
Supraclavicular injection of 30 milliliter 0.5 percent Bupivacaine + 0.2 milliliter Normal Saline solution (As a Placebo) with ultrasound guidance