Aim of this study: efficacy of Dexmedetomidine and Ketamin in Epidural anesthesia to Bupivacaine %0.25 to reduce postoperative analgesia in femur fracture. 105 patients with femur fracture divided randomly to three groups Dexmedetomidine and Ketamin and placebo ( 35 patient). We injected 0/5 gram Dexmedetomidine (30-35 gram) in first group and 25 milligram Ketamin ( 0/5 milliliter) in second group and 0/5 milliliter normal saline (0/5 milliliter) in control group. Vital sign recorded every 5 minute to 15 minute and every 15 minutes to 1 hour in surgery. We recorded vital sign and score of pain with Visual Analog scale in recovery. We recorded duration analgesia and score of pain in 4 and 12 and 24 hours after surgery and average of narcotic drug after surgery.
Inclusion criteria: age between 40-85 years; ASA I and II; no sensitivity to drugs; no history of substance abuse; lack of epidural contraindications; duration of surgery 90-120 minute.
Exclusion criteria: body mass image 35 and more; general anesthesia; duration surgery more than 120 minute; other fracture; chronic disease.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102620258N16
Registration date:2016-11-15, 1395/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-15, 1395/08/25
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Arak University of Medical Sciences
Expected recruitment start date
2016-10-07, 1395/07/16
Expected recruitment end date
2018-10-08, 1397/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Dexmedetomidine and Ketamin in Epidural
Anesthesia to Bupivacaine %0.25 to reduce postoperative Analgesia in fracture femur.
Public title
Efficacy of Dexmedetomidine and Ketamin in Epidural
Anesthesia to Bupivacaine %0.25 to reduce postoperative Analgesia in fracture femur.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 40-85 years; ASA I and II; lack of sensitivity to drugs; lack of substance abuse; lack of epidural contraindications; duration of surgery 90-120 minute.
Exclusion criteria: body mass index 35 and more; need to general anesthesia; duration surgery more than 120 minute; other fracture; chronic disease.
Age
From 40 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
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
Ethics committee Arak University of Medical Sciences