Clinical trial of evaluation the effect of dexmedetomidine administration during femoral neck fracture surgery on intraoperative hemodynamic factors and postoperative analgesic consumption in opium addicted patients
(1) Objectives: Evaluation the effect of dexmedetomidine administration during surgery on hemodynamic factors during surgery and analgesic consumption after surgery in opium addicted patients
(2) Design: This is a double blind randomized clinical trial conducted on 32 patients in Imam Hosein Hospital, Tehran, Iran.
(3) Setting and conduct: Following spinal anesthesia using hyperbaric bupivacaine, the patients were divided in two groups of intervention and control.
(4) Participants: 18-75 years old patients with a history of at least 6 consecutive weeks who candidate for femoral neck fracture surgery under spinal anesthesia were enrolled. Pregnant and breast feeding females, chronic pain, blood transfusion during surgery and intolerance to spinal anesthesia and need for general anesthesia were excluded.
(5) Intervention: In intervention group, dexmedetomidine at rate of 0.5 µgr/kg/hr and in control group normal saline with same volume was infused. At recovery, 2mg morphine was administered if visual analogue scale was more than 3. After transferring to the ward, participants were connected to patient controlled analgesia pomp.
(6) Main outcome measures: Vital sign changes, bleeding volume during surgery and pain onset after surgery and analgesic consumption during 24 hours after surgery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608019593N4
Registration date:2016-08-26, 1395/06/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-26, 1395/06/05
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
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of evaluation the effect of dexmedetomidine administration during femoral neck fracture surgery on intraoperative hemodynamic factors and postoperative analgesic consumption in opium addicted patients
Public title
Evaluation the effect of dexmedetomidine administration during surgery on intraoperative hemodynamic factors and postoperative analgesic consumption in opium addicted patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 18-75; Femoral neck fracture; candidate for surgery under spinal anesthesia; history of opium abuse for at least 6 weeks
Exclusion criteria: Pregnancy; breast feeding; history of chronic pain; long term analgesic use; BMI>35; diabetic; ischemic heart disease; cerebral vascular attacks; hypertension; malignancy; renal failure; hepatic failure; coagulopathy; history of drug allergy; need for blood transfusion during surgery; intolerance for spinal anesthesia
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization using random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Shahid Beheshti University of Medical Sciences
Street address
Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Velenjak Street
City
Tehran
Postal code
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
IR.SBMU.MSP.REC.1395.22
Health conditions studied
1
Description of health condition studied
Femoral Neck Fracture
ICD-10 code
S72.0
ICD-10 code description
Fracture of neck of femur
Primary outcomes
1
Description
Analgesic consumption
Timepoint
Until 24 hours after surgery
Method of measurement
Calculating the total dose of analgesic consumption by the researcher
Secondary outcomes
1
Description
Pain onset
Timepoint
After finishing the surgery until first request for analgesic
Method of measurement
Time measurment by researcher based on minutes
2
Description
Hemorrhage volume
Timepoint
From the begining until the end of surgry
Method of measurement
Calculating the bleeding volume based on mililiter by researcher
3
Description
Hemodynamic side effects
Timepoint
From drug administration until end of surgry
Method of measurement
Assessing hemodynamic changes using special monitoring device
Intervention groups
1
Description
Dexmetedomidine infusion at a rate of 0.5 µgr/kg/hr during surgery in intervention group
Category
Treatment - Drugs
2
Description
Normal saline infusion with the same volume and rate of dexmedetomidine during surgery in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hosein Hospital
Full name of responsible person
Dr. Elham Memary
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziyayi
Street address
Vice chancellor for research, 3rd floor, Medical School, Shahid Beheshti University of Medical Sciences, Velenjak, Tehran, Iran
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 for research, 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
Dr. Elham Memary
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Imam Hossein Hospital
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
drmemary@gmail.comdrmemary@sbmu.ac.ir
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. Alireza Mirkheshti
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Imam Hossein Hospital
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
drmirkheshti@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Elham Memary
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Imam Hossein Hospital
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
drmemary@gmail.comdrmemary@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)