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Investigating the effect of adding intravenous ketamine to Midazolam in reducing the need for analgesia after spinal anesthesia in elective cesarean section

Protocol summary

Study aim
Determining the effect of adding intravenous ketamine to Midazolam in reducing the need for analgesia after spinal anesthesia in elective cesarean section
Design
Clinical trial with control and parallel groups, randomized and double blind, phase 3 and conducted on 80 patients
Settings and conduct
This study will be conducted on 80 pregnant women referring to Imam Reza, Ghaem and Umm Al-Banin hospitals in Mashhad. In this clinical trial, women are randomly assigned to two different groups using the table of random numbers. In the intervention group, patients are injected with 0.5 mg/kg ketamine and 0.02 mg/kg midazolam in a 2ml syringe during cesarean section after umbilical cord clamping, and in the control group, they are only injected with 0.02 mg/kg midazolam. Pain intensity in patients is measured at 1, 6, 12, and 24 hours after labor. Apgar score of the newborn is measured at minutes 1 and 5 after birth. This study is double blind and the participants as well as the outcome assessors are unaware of the type of intervention and grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women over the age of 18 who have elective cesarean section with ASA I (American Anesthesiology Association). Exclusion criteria: History of trauma to head, addiction and use of psychiatric medication; hallucinations, delusions and hypertension; intracranial hemorrhage; history of ketamine allergy
Intervention groups
Intervention group: In this group, patients are injected with 0.5 mg/kg ketamine and 0.02 mg/kg midazolam in a 2ml syringe during cesarean section after umbilical cord clamping. Control group: In this group, patients are injected only with 0.02 mg/kg midazolam in a 2ml syringe during cesarean section after umbilical cord clamping.
Main outcome variables
Pain intensity, the amount of pain medication used, Apgar score of the newborn

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211013052753N1
Registration date: 2021-11-14, 1400/08/23
Registration timing: prospective

Last update: 2021-11-14, 1400/08/23
Update count: 0
Registration date
2021-11-14, 1400/08/23
Registrant information
Name
Mitra Samedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2031
Email address
mitra.samedi@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-16, 1400/08/25
Expected recruitment end date
2022-02-14, 1400/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of adding intravenous ketamine to Midazolam in reducing the need for analgesia after spinal anesthesia in elective cesarean section
Public title
The effect of adding intravenous ketamine to Midazolam in reducing the need for analgesia after spinal anesthesia in elective cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women over the age of 18 who have elective cesarean section with ASA I (American Anesthesiology Association)
Exclusion criteria:
History of trauma to head, addiction and use of psychiatric medication Hallucinations, delusions and hypertension Intracranial hemorrhage History of ketamine allergy
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with the table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and these envelopes will place the participants in one of the two groups of control and intervention. An anesthetic technician injects the syringes based on the numbers obtained from the random number table and the envelopes during the cesarean section.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants are not aware of the type of treatment and the intervention conducted in each group. That is, the patients are not aware of the type of injection used in each group. Similarly, outcome assessors are unaware of the grouping and the type of injection prescribed for patients in each group. No placebo drug will be used in this study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-05-25, 1400/03/04
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.119

Health conditions studied

1

Description of health condition studied
Fetal cesarean section
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified

Primary outcomes

1

Description
Pain intensity
Timepoint
At 1,6,12 and 24 hours after labor
Method of measurement
The visual analog scale (VAS) for pain

2

Description
The amount of pain medication used
Timepoint
During the first day after the intervention
Method of measurement
Based on milligrams of Apotel and meperidine used

3

Description
Apgar score of the newborn
Timepoint
Minutes 1 and 4 after birth
Method of measurement
Examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, patients are injected with 0.5 mg/kg ketamine and 0.02 mg/kg midazolam in a 2ml syringe during cesarean section after umbilical cord clamping.
Category
Treatment - Drugs

2

Description
Control group: In this group, patients are injected only with 0.02 mg/kg midazolam in a 2ml syringe during cesarean section after umbilical cord clamping.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Mitra Samedi
Street address
Ghaem hospital, Ahmad Abad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Email
mitra.samedi@ymail.com

2

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mitra Samedi
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2051
Email
mitra.samedi@ymail.com

3

Recruitment center
Name of recruitment center
Umm Al-Banin Hospital
Full name of responsible person
Mitra Samedi
Street address
Zarrineh Crossroads - Ayatollah Behjat Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9144734756
Phone
+98 51 3223 1061
Email
mitra.samedi@ymail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Saleheh Asghari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Email
AsghariSA@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saleheh Asghari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2051
Email
AsghariSA@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mitra Samedi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2051
Email
mitra.samedi@ymail.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
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data can be accessible through an email to the corresponding author.
Under which criteria data/document could be used
Data will be available for researchers in universities and other scientific institutes.
From where data/document is obtainable
After sending a request email to the corresponding author, data will be sent in 1 month.
What processes are involved for a request to access data/document
Carrying out analysis on data is permitted.
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