The Effect of perineural administration of dexmedetomidine on propofol and narcotic consumption and pain intensity in the patients undergoing femoral shaft fracture surgery
The goal of this study was to test whether it has any effect on pain intensity, opioid and propofol requirements when injected perineurally alone. Inclusion criteria were American Society of Anesthesiologists physical status I–II patients undergoing femoral fracture shafts surgery and their surgery duration was less than 3 hours. Exclusion criteria was allergy to an α2-adrenergic agonist or to one of the drugs used during the study, lidocaine and fentanyl; age <18 years, renal and hepatic failure; planned intraoperative use of regional analgesia; addicted patients, treatment or consumption psychotropic medication or an opioid agonist or antagonist in the 24 hours before surgery; treatment with α2-adrenergic agonist or antagonist; ASA physical status III–IV patients; and patient less or more than 40 and 100 kg weight, respectively. All patients with an elective femoral shaft fracture were selected in this study. The patients were randomly divided into two groups and dexmedetomidine, 100 µg, was only injected to surround the femoral nerve in one group. In both groups total intraoparative propofol and opioid consumption (3 hours), postoperative opioid consumption, visual analogue score for pain (24 hour postoperative) and hemodynamics parameters were recorded and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204309593N1
Registration date:2015-11-20, 1394/08/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-20, 1394/08/29
Registrant information
Name
Elham Memary
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 8082
Email address
drmemary@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-11-18, 1393/08/27
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of perineural administration of dexmedetomidine on propofol and narcotic consumption and pain intensity in the patients undergoing femoral shaft fracture surgery
Public title
The Effect of femoral block on IV anesthetic consumption and analgesia during anesthesia and post operation
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria: allergy to an α2-adrenergic agonist or to one of the drugs used during the study; atracurium; propofol; morphine; midazolam; dexmedetomidine; lidocaine and fentanyl; age <18 years, renal and hepatic failure; planned intraoperative use of regional analgesia; addicted patients, treatment or consumption psychotropic medication or an opioid agonist or antagonist in the 24 hours before surgery; treatment with α2-adrenergic agonist or antagonist; ASA physical status III–IV patients; and patient less or more than 40 and 100 kg weight, respectively.
Inclusion criteria: all patients with an elective femoral shaft fracture who had not exclusion criteria and their surgery duration was less than 3 hours were included in the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Shahid Beheshti commite, Beheshti University of Medical Scineces
Street address
Velenjak St
City
Tehran
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
349
Health conditions studied
1
Description of health condition studied
Femoral shaft fracture
ICD-10 code
S72.3
ICD-10 code description
Fracture of shaft of femur
Primary outcomes
1
Description
propofol consumption
Timepoint
during 3 hour intraoparative
Method of measurement
propofol consumption
2
Description
pain intensity
Timepoint
during 3 hour intraoparative and 6, 12, and 24 hour postoperative
Method of measurement
visual measurment
Secondary outcomes
1
Description
narcotic consumption
Timepoint
1, 2 and 3 hours intra-operative and 24 hour postoperative
Method of measurement
consumpted drug
Intervention groups
1
Description
In this Clinical Trail perineural administration of dexmedetomidine, 100 µg, was done before anesthesia.
Category
Treatment - Drugs
2
Description
In the control group anesthesia was done without perineural administration of dexmedetomidine and surgery was done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam-Hossein Hospital
Full name of responsible person
Elham Memary
Street address
Emam-Hossein Educational and Medical Center, Shahid Madani St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
anesthesiology research centre,shahid beheshti university of medical sciences
Full name of responsible person
alidabbagh
Street address
Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
anesthesiology research centre,shahid beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Memari
Position
Assistant Professor
Other areas of specialty/work
Street address
Velenjak
City
Tehran
Postal code
Phone
+98 21 7755 8082
Fax
Email
drmemary@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Elham Memary
Position
Assistant Professor
Other areas of specialty/work
Street address
Velenjak
City
Tehran
Postal code
Phone
+98 21 7755 8082
Fax
Email
drmemary@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Elham Memary
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 7755 8082
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)