The comparison of the effect of Suffentanil- dexmedetomidine in Spinal Anesthesia of Patients Undergoing lower abdominal and lower extremity surgery; a clinical trial study
Objective: an increased analgesic duration, a decreased need for postoperative analgesics.
Design: Sixty patients who will candidate for elective lower abdominal surgery under spinal anesthesia were entered. The randomization is done by using closed envelopes. Since this study can be effective in reducing side effects, this study is phase3.
Setting and conduct: This study is a prospective clinical trial, double blind and randomized control group (placebo) that will be performed in the Hospitals of Mashhad University of Medical Sciences onto patients who are candidates for lower abdominal and lower extremity surgery under spinal anesthesia with grade 1 and 2 ASA. The randomization is done by using closed envelopes.
Inclusion criteria: patients who are in the age range of 18-60 year; patient's consent of spinal anesthesia.
Exclusion criteria: Addiction; history of Diabetes; history of neuropathy; history of neuromascular disease; drug allergy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082833680N3
Registration date:2017-09-25, 1396/07/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-25, 1396/07/03
Registrant information
Name
Farideh Golhasani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
golhasanif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of Suffentanil- dexmedetomidine in Spinal Anesthesia of Patients Undergoing lower abdominal and lower extremity surgery; a clinical trial study
Public title
The effect of Suffentanil- dexmedetomidine in Spinal Anesthesia of Patients Undergoing lower abdominal and lower extremity surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who are in the age range of 18-60 year; patient's consent of spinal anesthesia.
Exclusion criteria: Addiction; history of diabetics; history of neuropathy; history of neuromascular disease; drug allergy
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical Sciences; International Offic Administration Center(Qoreishi Building) ; Daneshgah St., Mashhad
City
Mashhad
Postal code
13944-91388
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
IR.MUMS.fm.REC.1394.547
Health conditions studied
1
Description of health condition studied
Lower abdominal and lower extremity surgery under spinal anesthesia
ICD-10 code
F44.6
ICD-10 code description
Dissociative anaesthesia and sensory loss
Primary outcomes
1
Description
Duration of sensory and motor blockade
Timepoint
After surgery
Method of measurement
Time
2
Description
Return of hemodynamic changes blocked
Timepoint
After surgery
Method of measurement
Questionnare
3
Description
Housing consumption
Timepoint
After surgery
Method of measurement
Dosage
Secondary outcomes
1
Description
Age
Timepoint
Before intervention
Method of measurement
Years
2
Description
Sex
Timepoint
Before intervention
Method of measurement
Male of female
Intervention groups
1
Description
The control group received 15 mg bupivacaine plus 3 μg of sufentanil
Category
Placebo
2
Description
The intervention group received 15 mg bupivacaine plus 3 μg of sufentanil and 10 μg doxedemodoimidine to spinal anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Mojtaba Karimi
Street address
Department of Anesthesiology, Imam Reza Hospital, Square Taghiabad,Khorasan Razavi
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahyar Mirheidari
Street address
Mashhad University of Medical Sciences; International Offic Administration Center (Qoreishi Building) ; Daneshgah St., Mashhad.
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mojtaba Karimi
Position
Resident/ Colleague
Other areas of specialty/work
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Square Taghi-Abad
City
Mashhad
Postal code
9137913316
Phone
+98 518022711
Fax
Email
Kaimim931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mojtaba Karimi
Position
Resident of anesthesia
Other areas of specialty/work
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Square Taghi-Abad Khorasan Razavi
City
Mashhad
Postal code
Iran
Phone
+98 518022711
Fax
Email
Kaimim931@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farideh Golhasani
Position
Master
Other areas of specialty/work
Street address
Square of Taghi Abad, Imam Reza Hosital, Anesthesia Research Center. Mashhad
City
Mashhad
Postal code
9137913316
Phone
+98 38538659
Fax
Email
golhasanif1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)