Protocol summary

Study aim
Comparison of the effects of morphine along with low dose naloxone and dexmedetomidine during analgesia after cesarean section under spinal anesthesia
Design
Clinical trial with a control group, with parallel groups, doubleblind,randomized, phase 3 on 90 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This study is a double-blind randomized clinical trial that was conducted in Imam Khomeini Sari Educational-Therapeutic Hospital in Mazandaran province on women who are candidates for elective cesarean delivery between 18 and 50 years old who are the first and second gravid. will be executed. Patients will be randomly divided into three groups A, B and C based on a computerized list which is a statistic and does not know about the people present in the treatment groups. 2) and the receiving patient are not aware of the content of the injected drug.
Participants/Inclusion and exclusion criteria
Entry conditions: women aged 18 to 50 years, elective cesarean delivery, first and second gravidExclusion criteria: patient refusal to participate in the study, failure to create the required level of anesthesia and conversion of spinal anesthesia to general, history of drug addiction, history of sensitivity to any of the drugs used in this research, history of known heart disease vascular, liver, kidney and blood coagulation problems and asthma, scoliosis or kyphosis or morbid obesity, height less than 130 cm and BMI higher than 35
Intervention groups
Intervention group: 100 micrograms of morphine with 2.5 cc of bupivacaine 0.5% plus a low dose of 2 micrograms of naloxone. Intervention group: 1 microgram (dexmedetomidine) with 2.5 cc bupivacaine 0.5% Control group: 2.5 cc of bupivacaine 0.5% will be injected intrathecally
Main outcome variables
Pain intensity, sedation scores

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161126031095N5
Registration date: 2023-08-10, 1402/05/19
Registration timing: prospective

Last update: 2023-08-10, 1402/05/19
Update count: 0
Registration date
2023-08-10, 1402/05/19
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
2023-08-12, 1402/05/21
Expected recruitment end date
2023-10-13, 1402/07/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of adding dexmedetomidine and low dose of naloxone to morphine on the pain-free period of post-operative analgesia after spinal anesthesia in cesarean section
Public title
Comparing the effect of adding dexmedetomidine and low dose of naloxone to morphine on the pain-free period of post-operative analgesia after spinal anesthesia in cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18 to 50 years Elective cesarean birth for first and second gravid
Exclusion criteria:
Patient refusal to participate in the study Failure to create the required level of anesthesia and turning spinal anesthesia into general History of drug addiction History of allergy to any of the drugs used in this research History of known cardiovascular, liver, kidney disease and blood coagulation problems and asthma Scoliosis or kyphosis or morbid obesity Height less than 130 cm and BMI greater than 35 Ketamine or narcotic injection to treat shivering in the second line
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be divided based on the basic variables: age and gestational age. The participants will be randomly divided into 3 groups: 1) 100 micrograms of morphine with 2.5 cc of bupivacaine 0.5% plus a low dose of 2 micrograms of naloxone 2) 1 microgram of dexmedetomidine with 2.5 cc of bupivacaine 0.5% 3) 2.5cc bupivacaine 0.5% All syringes containing medicine are transparent and in the same volume and different concentrations which are delivered in sealed envelopes, the patients are divided into three groups A, B and C based on the computer list which is a statistic, there is no information about the people present in the treatment groups the people present in the treatment groups
Blinding (investigator's opinion)
Double blinded
Blinding description
All the syringes containing drugs are transparent and in the same volume and different concentrations, only the project manager (senior anesthesiology assistant) administers morphine, naloxone and dexmedetomidine drugs with a certain effective dose to add to bupivacaine to the second year anesthesiology assistants. to perform spinal) delivers. The injecting doctor (second-year anesthesiology resident) and the receiving patient are not aware of the content of the injected drug.
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 Educational and Medical Hospital (RA) Sari - Mazandaran University
Street address
Office Building Ethics Committee of Imam Khomeini Hospital Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
48166-33131
Approval date
2023-02-01, 1401/11/12
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1402.013

Health conditions studied

1

Description of health condition studied
Intensity of pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
Severity of patients' pain
Timepoint
In hours 2, 4, 8, 12 after surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Sedation score
Timepoint
In hours 2, 4, 8, 12 after surgery
Method of measurement
Reverse Observer Assessment Scale of Consciousness/Sedation

Intervention groups

1

Description
Intervention group: 100 micrograms of morphine (manufactured by Abu Rehan Company) with 2.5 cc of bupivacaine 0.5% (manufactured by Abu Rehan Pharmaceuticals) plus a low dose of 2 micrograms of naloxone (manufactured by Drug Manufacturing Company) as a single dose by injection.
Category
Treatment - Surgery

2

Description
Intervention group:1 microgram of dexmedetomidine (manufactured by Elixir Pharmaceutical Company) with 2.5 cc of bupivacaine 0.5% (manufactured by Abu Rahian Pharmaceutical Company) as a single dose by injection
Category
Treatment - Surgery

3

Description
2.5 cc bupivacaine 0.5% (manufactured by Abu Rahian Pharmaceuticals) intrathecally as a single dose by injection
Category
Treatment - Surgery

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 1700
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
Iran 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

Person responsible for scientific inquiries

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

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
+98 911 151 7833
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
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