The effect of dexmedetomidine and neostigmine on reducing postoperative pain by cesarean section with spinal anesthesia
Design
Randomization is based on block randomization, which is double-blind
The sample size is calculated in each group of 51 people. Patient. Excel software rand function was used for randomization.
Settings and conduct
This study is a randomized clinical trial study that will be performed at Imam Khomeini Hospital in Sari, Mazandaran Province, on women who are candidates for cesarean delivery and are between 18 and 50 years old.
Participants/Inclusion and exclusion criteria
Women who have had a cesarean delivery and are between 18 and 50 years old.
Intervention groups
It consisted of two groups of 51 women who were candidates for cesarean section and efficacy o f dexmedetomidine and neostigmine that added to bupivacaine for spinal anesthesia has compared
Main outcome variables
Pain based on visual analog scale criteria; Calming based on Ramsey criteria; Immobility according to Broming criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161126031095N2
Registration date:2021-07-13, 1400/04/22
Registration timing:retrospective
Last update:2021-07-13, 1400/04/22
Update count:0
Registration date
2021-07-13, 1400/04/22
Registrant information
Name
Alieh Zamani Kiasari
Name of organization / entity
Mazandaran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3335 5080
Email address
azamani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
2020-12-05, 1399/09/15
Actual recruitment end date
2021-03-02, 1399/12/12
Trial completion date
2021-04-19, 1400/01/30
Scientific title
Comparison of the additive effect of dexmedetomidine and neostigmine to bupivacaine on pain intensity after cesarean section with spinal anesthesia
Public title
Comparison of the additive effect of dexmedetomidine and neostigmine to bupivacaine on pain intensity after cesarean section with spinal anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have had a cesarean delivery
Exclusion criteria:
Patients who have refused to participate
Drug addiction
Have underlying diseases (moderate or severe heart, kidney, lung or nerve disease, significant scoliosis, kyphosis, obesity or blood clotting disease)
Patients with a height of less than 130 cm or aBody mass Index ( BMI) of more than 35
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
110
Actual sample size reached:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by randomized block method with various block sizes (multiples of 2). The unit is individual and is made by statistical software and delivered in a sealed envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The facilitator, the senior assistant performing spinal anesthesia, and the anesthesist present at the patient's bedside, as well as the first-year assistant filling out research forms were kept blind for each patient' administered drugs. The drugs were the same color and volume in the same syringes that could not be differentiated by the above individuals
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital of Sari - Mazandaran University of Medical Sciences
Street address
Office Building Ethics Committee of Imam Khomeini Hospital Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
48166-33131
Approval date
2020-11-25, 1399/09/05
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1399.062
Health conditions studied
1
Description of health condition studied
Other acute postprocedural pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain after cesarean section
Timepoint
Hours 0, 2, 4, 8 and 12
Method of measurement
According to the Visual Analogue Scale criteria
Secondary outcomes
1
Description
Sedation
Timepoint
0,2,4,8,12
Method of measurement
Ramsay Criteria
2
Description
Immobilization
Timepoint
0,2,4,8,12
Method of measurement
Bromage scale
3
Description
Moderate arterial blood pressure
Timepoint
0,2,4,8,12
Method of measurement
Checklist
4
Description
Oxygen saturation
Timepoint
0,2,4,8,12
Method of measurement
pulse oximetry
5
Description
Apgar score
Timepoint
0,2,4,8,12
Method of measurement
Checklist
Intervention groups
1
Description
Intervention group1: 1 microgram of dexmedetomidine is equivalent to a volume of 0.5 ml plus 2.5 ml of 0.5% bupivacaine. As a result, the total injection volume in each sample is 3 ml, which have the same color and shape. No. 25 and is performed from the lumbar intervertebral space in the cerebrospinal fluid
Category
Treatment - Drugs
2
Description
Intervention group2:10 micrograms of neostigmine is equivalent to a volume of 0.5 ml plus 2.5 ml of 0.5% bupivacaine. As a result, the total injection volume in each sample is 3 ml, which have the same color and shape. Spinal cord No. 25 and is performed from the lumbar intervertebral space in the cerebrospinal fluid
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Alieh Zamani Kiasari
Street address
Imam Khomeini Hospital, Amir Mazandarani Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1630
Email
aliehzamani@yahoo.com
Web page address
https://www.mazums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saedi
Street address
Moalem Ave
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3325 7230
Email
m.saedi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Iman Asdaghi Jahromi
Position
Anesthesia Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3335 5080
Fax
+98 11 3335 5080
Email
Iman.asdaghi@gmail.com
Web page address
https://www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Alieh Zamani Kiasari
Position
Assistance professor of Anesthesiology and Intensive Care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3335 5080
Fax
+98 11 3335 5080
Email
aliehzamani@yahoo.com
Web page address
https://www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Alieh Zamani Kiasari
Position
Associate Professor of Anesthesiology and Vegetative Care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3335 5080
Fax
+98 11 3335 5080
Email
aliehzamani@yahoo.com
Web page address
https://www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available