To evaluate the incidence of shivering, analgesic quality and post-operative complications of cesarean section, treated with sputum sufentanil and tramadol
To evaluate the incidence of shivering, analgesic quality and post-operative complications of cesarean section, treated with sputum sufentanil and tramadol
Design
randomized (random block method), double-blind study, without placebo control, single arm trial.
The sample size of this study is 135 individuals: divided into 3 groups of 45 people.
Settings and conduct
Amiralmomenin Hospital in Semnan
Participants/Inclusion and exclusion criteria
Women are in the age of 18-40 years old, which candidate for a repeated nonprescription cesarean section at Amiralmomenin Hospital in Semnan.
Inclusion Criteria: No Contraindication of Spinal Anesthesia; No history of sensitivity to the three drugs used in this study and other local anesthetics; no neuropathy; no previous history of non-gestational cesarean.
Exclusion criteria: women with GI disease; preterm delivery; febrile women (sub-axillary temperature greater than 37.5); preeclampsia; obese women (BMI> 35); cesarean delivery more than 4 times; receiving antiemetic drugs 24 hours before Surgery; Patients with gestational hypertension; Narcotic recipients during surgery; Diabetic; History of PONV; Receiving misoprostol; Patients who cannot perform medication.
Intervention groups
Intervention group 1: Spinal anesthesia with 2.5 cc Bupivacaine 0.5%
Intervention group 2: Spinal anesthesia with 2.5 cc bupivacaine 0.5% and 10 mg tramadol.
Intervention group 3: Spinal anesthesia with 2.5 cc of bupivacaine 0.5% and 10-5 micrograms (equivalent to 1-2 cc) of sufentanil.
Main outcome variables
Pain relief time, Chill
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N25
Registration date:2017-12-20, 1396/09/29
Registration timing:retrospective
Last update:2017-12-20, 1396/09/29
Update count:0
Registration date
2017-12-20, 1396/09/29
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the incidence of shivering, analgesic quality and post-operative complications of cesarean section, treated with sputum sufentanil and tramadol
Public title
To evaluate the incidence of shivering, analgesic quality and post-operative complications of cesarean section, treated with sputum sufentanil and tramadol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No Contraindication of Spinal Anesthesia
No history of sensitivity to the three drugs used in this study and other local anesthetics
no neuropathy
no previous history of non-gestational cesarean
Women 18 to 40 years
Exclusion criteria:
women with GI disease
preterm delivery
febrile women (sub-axillary temperature greater than 37.5)
preeclampsia
obese women (BMI> 35)
cesarean delivery more than 4 times
receiving antiemetic drugs 24 hours before Surgery
Patients with gestational hypertension
Narcotic recipients during surgery
Diabetic
History of PONV
Receiving misoprostol
Patients who cannot perform medication
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized (random block method)
Blinding (investigator's opinion)
Double blinded
Blinding description
Injections were performed by the anesthesiologist with spinal cord needle number 25 from lumbar space L4-L5. (The anesthetist and Participate did not know the contents of the syringe).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.SEMUMS.REC.1395.209
Health conditions studied
1
Description of health condition studied
Complications after cesarean section
ICD-10 code
O34.21
ICD-10 code description
Maternal care for scar from previous cesarean delivery
Primary outcomes
1
Description
Pain relief time
Timepoint
Before and after anesthesia and after delivery (first 20 minutes, every 3 minutes and up to recovery, every 5 minutes), measurements are recorded and recorded.
Method of measurement
Examination
2
Description
Chill
Timepoint
Before and after anesthesia and after delivery (first 20 minutes, every 3 minutes and up to recovery, every 5 minutes), measurements are recorded and recorded.
Method of measurement
See
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Spinal anesthesia with 2.5 cc Bupivacaine 0.5%
Category
Treatment - Other
2
Description
Intervention group 2: Spinal anesthesia with 2.5 cc bupivacaine 0.5% and 10 mg tramadol.
Category
Treatment - Other
3
Description
Intervention group 3: Spinal anesthesia with 2.5 cc of bupivacaine 0.5% and 10-5 micrograms (equivalent to 1-2 cc) of sufentanil.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Elham saffarieh
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Scienes, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham saffarieh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham saffarieh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Neda Tebyanian
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 33451336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Elham saffarieh.
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd, Semnan.
00989123313982
What processes are involved for a request to access data/document