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the efficacy of intravenous midazolam on maternal hemodynamic status and neonatal apgar score in cesarean section under spinal anesthesia

Protocol summary

Study aim
Overall Objective: To determine the effect of intravenous midazolam on maternal hemodynamic status and neonatal Apgar score in cesarean section under spinal anesthesia
Design
A controlled, parallel-group, single-blind, randomized, phase 2-3 clinical trial on 108 patients.
Settings and conduct
After obtaining the approval of the ethics committee, all patients who are candidates for cesarean surgery with spinal anesthesia in Bahlul Gonabadi Hospital will be selected based on the entry criteria. Patients do not know what intervention is being done on them and in which group they are. One group will be injected with midazolam 10 minutes before the start of spinal anesthesia, and the control group will receive conventional treatment. The hemodynamic status of patients in two groups will be monitored during the operation and will be recorded every 5 minutes. After the birth of the baby, Apgar 1 and 5 minutes of the baby will be examined and recorded. The method of performing spinal anesthesia will be the same for all research units. Serum therapy will be the same in all patients.
Participants/Inclusion and exclusion criteria
Entry conditions: pregnant patient candidate for caesarean section with spinal anesthesia, mother's consent, anesthesia class 1 and 2, body mass index less than 35, age range 18 to 45 years, absence of fetal distress. Conditions of non-entry: unfavorable condition of the fetus during pregnancy (fetal distress), severe systemic disease, high blood pressure during pregnancy, emergency caesarean section, presence of any abnormality in the fetus.
Intervention groups
Intervention group: Midazolam will be injected 10 minutes before the start of spinal anesthesia. Control group: will receive the usual treatment, which means they will receive midazolam after the baby is born.
Main outcome variables
Hemodynamic factors; Neonatal Apgar

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220501054718N1
Registration date: 2022-08-02, 1401/05/11
Registration timing: registered_while_recruiting

Last update: 2022-08-02, 1401/05/11
Update count: 0
Registration date
2022-08-02, 1401/05/11
Registrant information
Name
Arash Hamzeie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 4222
Email address
hamzeie.a@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-01, 1401/05/10
Expected recruitment end date
2022-10-02, 1401/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the efficacy of intravenous midazolam on maternal hemodynamic status and neonatal apgar score in cesarean section under spinal anesthesia
Public title
the efficacy of intravenous midazolam on maternal hemodynamic status and neonatal apgar score in cesarean section under spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant patient who is a candidate for cesarean section with spinal anesthesia Mother's satisfaction Term fetus Anesthesia class 1 or 2 Absence of history of mental disorders Body mass index less than 35 No history of preeclampsia Age range 45-18 years Absence of fetal distress No history of eclampsia No history of taking psychotropic drugs Fetus without anomalies
Exclusion criteria:
Improper condition of the fetus during pregnancy (fetal distress) A fetus that is going to be born before the 37th week of pregnancy (preterm) Severe systemic disease (hepatitis, diabetes, Chronic obstructive pulmonary disease(COPD), End-stage kidney disease(ESRD), alcohol dependence) High blood pressure during pregnancy Emergency caesarean section The presence of any abnormality in the fetus History of seizures during pregnancy
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation using permutation blocks. In this way, in the permutation block method of four, the letter A will represent the intervention group and the letter B will represent the control group. There are six possible states in blocks of four ABBA, AABB, BAAB, BBAA, ABAB, BABA, one number will be assigned to each block and each time one number will be selected by lottery and the patients will enter the study in order.
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that this research compares the results of midazolam injection to the mother before and after the baby is born, a consent form explaining the possible positive and negative effects of midazolam will be given to the patient. However, the patient is not told which of the intervention groups (midazolam injection before the start of the spinal cord) and control (midazolam injection after the baby is discharged) will be placed, and in this sense the patient will be kept blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
No. 0, Imam Khomeini Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2022-05-07, 1401/02/17
Ethics committee reference number
IR.GMU.REC.1401.033

Health conditions studied

1

Description of health condition studied
Hemodynamic status
ICD-10 code
JB22.0
ICD-10 code description
Delivery by elective caesarean section

2

Description of health condition studied
Neonate Apgar score
ICD-10 code
KB21
ICD-10 code description
Birth asphyxia

Primary outcomes

1

Description
hemodynamic factors
Timepoint
Before starting spinal anesthesia, every 5 minutes during the procedure
Method of measurement
monitoring

2

Description
Neonatal Apgar
Timepoint
The first minute and the fifth minute after birth
Method of measurement
Neonatal Apgar score checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will be intravenously injected with midazolam at a bolus dose of 0.02 miligram per kilogram 10 minutes before the start of spinal anesthesia (that is, at the start of fluid therapy). The ampoule of midazolam used in this research is 5 miligram per 1 milliliter and is a product of Tehran Chemical Company, which is diluted with 4 milliliter of distilled water. (concentration 5 miligram per 5 milliliter )
Category
Treatment - Drugs

2

Description
Control group: This group will receive intravenous midazolam with a bolus dose of 0.02 miligram per kilogram after the birth of the baby. (common treatment). The ampoule of midazolam used in this research is 5 miligram per 1 milliliter and is a product of Tehran Chemical Company, which is diluted with 4 milliliter of distilled water. (concentration 5 miligram per 5 milliliter )
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Allameh Behlool Hospital
Full name of responsible person
Dr. Arash Hamzei
Street address
No. 48, Emam Ali Ave.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691986765
Phone
+98 51 5725 4222
Email
Hamzeie.a@gmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Leila Sadegh Moghadam
Street address
No. 0, Imam Khomeini Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0578
Email
research@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Arash Hamzei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 48,Emam Ali Ave.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691986765
Phone
+98 51 5725 4222
Email
Hamzeie.a@gmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Arash Hamzei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 48, Emam Ali Ave.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691986765
Phone
+98 51 5725 4222
Email
Hamzeie.a@gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Arash Hamzei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 48,Emam Ali Ave.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691986765
Phone
+98 51 5725 4222
Email
Hamzeie.a@gmu.ac.ir

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
Undecided - It is not yet known if there will be 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
The data related to the main outcome will be shared in the extracted article.
When the data will become available and for how long
After the publication of the results and probably in the winter of 1401
To whom data/document is available
Available to other researchers
Under which criteria data/document could be used
Meta-analysis and related statistical tests
From where data/document is obtainable
Vice Chancellor for Research and Technology of Gonabad University of Medical Sciences
What processes are involved for a request to access data/document
Request to the Vice Chancellor for Research, Referral to the School of Paramedical, Referral to the Department of Anesthesiology and the relevant researcher
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