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Comparative study of the effectiveness of dexmedetomidine with sufentanil in adding intrathecal ropivacaine on analgesia in the elective cesarean section - A Randomized Double-Blind Clinical Trial

Protocol summary

Study aim
Determination of the effectiveness of dexmedetomidine with sufentanil in intrathecal ropivacaine supplementation on analgesia in the elective cesarean section.
Design
This study is a double-blinded clinical trial. One hundred and thirty-six patients will be selected in an available method and simple randomly assigned to two intervention groups. Then the intervention is done. After the surgery, the pain and duration of analgesia and headaches are measured by means of the VAS tool and recorded in the checklist, and the two groups are compared with each other.
Settings and conduct
The study will be performed in the gynecology ward of Imam Reza Hospital in Kermanshah. Randomization of patients between the first intervention group (dexmedetomidine /ropivacaine ) and the second group(sufentanil /ropivacaine) is done using random allocation software. In this software, the total sample size and number of nodes are entered into the software. The output of Shalam software is a list that randomly distributes patients in groups 1 and 2.
Participants/Inclusion and exclusion criteria
Inclusion criteria include singleton and term pregnant women aged 18 to 45 years, having a body mass of 18 to 30 with ASA class I. Exclusion criteria include having any underlying disease, history of allergy to local anesthetic, dexmedetomidine and sufentanil, coagulation disorders, local skin infection at the site of spinal anesthesia, surgery Emergency cesarean section, and cases where we have to undergo general anesthesia during surgery.
Intervention groups
In the first intervention group, 5 micrograms of dexmedetomidine and 12.5 micrograms of isobaric ropivacaine 0.5%, and in the second intervention group, 5 micrograms of sufentanil with 12.5 micrograms of isobaric ropivacaine 0.5% isobars are injected intrathecally into the subarachnoid space.
Main outcome variables
Time of onset of analgesia, duration of analgesia.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201212049688N1
Registration date: 2021-05-18, 1400/02/28
Registration timing: registered_while_recruiting

Last update: 2021-05-18, 1400/02/28
Update count: 0
Registration date
2021-05-18, 1400/02/28
Registrant information
Name
haniyeh azadifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 4618
Email address
haniyeh.azadifar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effectiveness of dexmedetomidine with sufentanil in adding intrathecal ropivacaine on analgesia in the elective cesarean section - A Randomized Double-Blind Clinical Trial
Public title
Evaluation of the effectiveness of dexmedetomidine with sufentanil in combination with intrathecal ropivacaine on analgesia in cesarean section
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
singleton and term pregnant women 18 to 45 years. Having a body mass of 18 to 30. Patients referred for elective cesarean section, who are classified as Class I according to the American Society of Anesthesiology (A.S.A).
Exclusion criteria:
Having any underlying disease History of allergy to local anesthetic Coagulation disorders, local skin infection at the site of spinal anesthesia Surgery Emergency cesarean section Cases where we have to undergo general anesthesia during surgery
Age
From 18 years old to 30 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients between the first intervention group (dexmedetomidine with ropivacaine ) and the second intervention group(sufentanil with ropivacaine) is done using random allocation software. In this software, the total sample size and number of nodes are entered into the software. The output of Shalam software is a list that randomly distributes patients in groups 1 and 2. Patients are divided into two groups according to the time of referral according to the list of the mentioned group until the end of sampling.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person in charge of injecting drugs is not aware of the allocation of individuals to groups. The person evaluating the patients is also unaware of the allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Kermanshah University of Medical Science
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.Kermashah,Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-02-16, 1399/11/28
Ethics committee reference number
IR.KUMS.REC.1399.1136

Health conditions studied

1

Description of health condition studied
Cesarean section
ICD-10 code
O75.82
ICD-10 code description
Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section

Primary outcomes

1

Description
Time of onset of analgesia.
Timepoint
1,2,4,6,8,10,12,16,20,24 hours after the end of the surgery.
Method of measurement
With Visual Analog Scale.

2

Description
duration of analgesia
Timepoint
1,2,4,6,8,10,12,16,20,24 hours after the end of the surgery.
Method of measurement
With Visual Analog Scale.

Secondary outcomes

1

Description
Blood pressure changes
Timepoint
In minutes 1,5,10,15,20,25,30,60 after injection
Method of measurement
By barometer and registration in the relevant forms.

2

Description
Nausea
Timepoint
After the intervention
Method of measurement
By asking the patient questions and observing objectively.

3

Description
Vomiting
Timepoint
After the intervention
Method of measurement
By asking the patient questions and observing objectively.

4

Description
Headache
Timepoint
After the intervention
Method of measurement
By Visual Analog Scale.

5

Description
heart rate
Timepoint
In minutes 1,5,10,15,20,25,30,60 after injection
Method of measurement
By pulse oximeter.

6

Description
respiratory distress
Timepoint
After the intervention
Method of measurement
By objective observation.

Intervention groups

1

Description
Intervention group: In the first intervention group, 5 micrograms of dexmedetomidine and 12.5 micrograms of isobaric ropivacaine 0.5% are injected intrathecally into the subarachnoid space.
Category
Treatment - Drugs

2

Description
Intervention group: In the second intervention group, 5 micrograms of sufentanil with 12.5 micrograms of isobaric ropivacaine 0.5% isobars are injected intrathecally into the subarachnoid space.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital-Kermanshah
Full name of responsible person
Hanieh Azadifar
Street address
Next to the medical school, the end of Parstar Blvd, Kermanshah , Iran.
City
Kermanshah
Province
Kermanshah
Postal code
674277533
Phone
+98 83 3427 6300
Email
hooman.rafiee@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Taleghani Hospital, Taleghani Street, Kermanshah, Iran.
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3837 0541
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Hanieh Azadifar
Position
Anesthesia resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Next to the medical school, the end of Parstar Blvd, Kermanshah, Iran.
City
Kermanshah
Province
Kermanshah
Postal code
674277533
Phone
+98 83 3427 6300
Email
hooman.rafiee@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hanieh Azadifar
Position
Anesthesia resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Next to the medical school, the end of Parstar Blvd, Kermanshah, Iran.
City
Kermanshah
Province
Kermanshah
Postal code
674277533
Phone
+98 83 3427 6300
Email
hooman.rafiee@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hanieh Azadifar
Position
Anesthesia resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Next to the medical school, the end of Parstar Blvd, Kermanshah, Iran.
City
Kermanshah
Province
Kermanshah
Postal code
674277533
Phone
+98 83 3427 6300
Email
hooman.rafiee@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data on demographic information and the onset and duration of analgesia in patients are shared as anonymous codes.
When the data will become available and for how long
Data access to 2022 is possible.
To whom data/document is available
Access to the data will be open to those interested in research
Under which criteria data/document could be used
Giving data for scientific use is permissible without bias
From where data/document is obtainable
Can be contacted by .
What processes are involved for a request to access data/document
About a week from the time of the first email call.
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