Protocol summary

Summary
Aim of this study compared the effects of adding Dexmedetomidine ‎and tramadol to lidocaine 5% in ‎the duration of postoperative analgesia in spinal anesthesia in women ‎undergoing cesarean section. ‎This study is clinical trials and double blind. 180 women will enter in this study. We will divide women in ‎three groups (Dexmedetomidine ‎and tramadol and placebo) randomly. We will check pain and ‎duration analgesia and mean narcotic in 24 hours after cesarean and nausea and vomiting after 24 ‎hours. ‎ Inclusion criteria: 20-40 years; cesarean elective candidate Taleghani hosbital; ASA I and II; lack of allergy in Lidocaine and Tramadol and Dexmedetomidine Exclusion criteria: failure in Spinal anesthesia; more than two attempts for spinal anesthesia; prolongation of surgery more than 90 minutes; Patients with substance abuse; patients with cardiovascular and pulmonary

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017060620258N49
Registration date: 2017-06-18, 1396/03/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-18, 1396/03/28
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
2016-04-29, 1395/02/10
Expected recruitment end date
2018-04-30, 1397/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compared the effects of adding Dexmedetomidine ‎and tramadol to lidocaine 5% in the duration of postoperative analgesia in spinal anesthesia in women undergoing cesarean section
Public title
Compared the effects of adding Dexmedetomidine ‎and tramadol to lidocaine 5% in the duration of postoperative analgesia in spinal anesthesia in women ‎undergoing cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20-40 years; cesarean elective candidate Taleghani hosbital; ASA I and II; lack of allergy in Lidocaine and Tramadol and Dexmedetomidine Exclusion criteria: failure in Spinal anesthesia; more than two attempts for spinal anesthesia; prolongation of surgery more than 90 minutes; Patients with substance abuse; patients with cardiovascular and pulmonary
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 180
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
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2016-04-25, 1395/02/06
Ethics committee reference number
IR.ARAKMU.REC.1395.17

Health conditions studied

1

Description of health condition studied
Elective cesarean
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section

Primary outcomes

1

Description
duration analgesia‎
Timepoint
24 hours after cesarean
Method of measurement
minute

2

Description
mean narcotic ‎
Timepoint
24 hours after cesarean
Method of measurement
miligeram

3

Description
Pain
Timepoint
recavery and 4 and 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale Questionnaire

4

Description
Nausa and vomitting
Timepoint
24 hours after cesarean
Method of measurement
observation

Secondary outcomes

empty

Intervention groups

1

Description
Control group: We will inject 0.5 milliliter normal saline.
Category
Treatment - Drugs

2

Description
Intervention group: We will inject 25 milligram Teramadol ( 0.5 milliliter).
Category
Treatment - Drugs

3

Description
Intervention group: We will inject 25 milligram Dexmedetomidine ( 0.5 milliliter).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Emam Khomeini street, Taleghani hospital
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Arak University of Medical Sciences
Full name of responsible person
Dr Anoshirvani
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
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, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Maryam Shokrpour
Position
Faculty Member, Gynechologist
Other areas of specialty/work
Street address
Emam Khomeini street, Taleghani hospital
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
alikamaliir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Faculty Member, Anesthesiologist
Other areas of specialty/work
Street address
Shahid Shirodi street, Valiasr squre, Valiasr hospital
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
alikamali@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Radmehr Aminloo
Position
Medical Student
Other areas of specialty/work
Street address
Complex Payambar azam, Basij squre, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
alikamaiir@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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