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CTRI Number  CTRI/2025/06/089590 [Registered on: 26/06/2025] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A STUDY TO ASSESS THE ANXIOLYTIC EFFECTIVENESS OF MIDAZOLAM IN PATIENTS OF CESAREAN SECTION  
Scientific Title of Study   A Randomized Controlled Study To Evaluate The Anxiolytic Effect Of Midazolam In Patients Of Cesarean Section At S M S Medical College ,Jaipur  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Trishala Jain 
Designation  Seniour Professor 
Affiliation  Sawai Man Singh Medical College Jaipur 
Address  Department Of Anaesthesiology Second Floor Dhanvantri Complex S M S Medical College Jaipur Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9414281744  
Fax    
Email  trishala.jain31@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Trishala Jain 
Designation  Seniour Professor 
Affiliation  Sawai Man Singh Medical College Jaipur 
Address  Department Of Anaesthesiology Second Floor Dhanvantri Complex S M S Medical College Jaipur Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9414281744  
Fax    
Email  trishala.jain31@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rohit Bairwa 
Designation  Junior Resident 
Affiliation  Sawai Man Singh Medical College Jaipur 
Address  Department Of Anaesthesiology Second Floor Dhanvantri Complex S M S Medical College Jaipur Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  6376783315  
Fax    
Email  rohit20061994@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology Second Floor Dhanvantri Complex S M S Medical College J L N Marg Jaipur Rajasthan India Pin code 302004 
 
Primary Sponsor  
Name  Sawai Man Singh Medical CollegeJaipur 
Address  Department Of Anaesthesiology Second Floor Dhanvantri Complex S M S Medical College J L N Marg Jaipur Rajasthan India Pin code 302004 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Trishala Jain  Sawai Man Singh Medical College And Attached Hospitals  Department Of Anaesthesiology Second Floor Dhanvantri Complex S M S Medical College Jaipur
Jaipur
RAJASTHAN 
9414281744

trishala.jain31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office Of The Ethics Committee S M S Medical College And Attached Hospitals Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal Saline Placebo   Identical Volume Of 0.9% Saline Placebo Solution Before The Spinal Anaesthesia 
Intervention  Prophylactic Injection Prior To Spinal Anaesthesia  Single Intravenous Bolus Of Midazolam 0.0125mg/kg Before The Spinal Anaesthesia ,Dose - 0.0125mg/kg ,Route - Intravenous ,Single Dose Administration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Patients Undergoing Cesarean Section
2.Patients Giving Informed Written Consent
3. Patients Belonging To American Society Of Anaesthesiologist Physical Status 2 
 
ExclusionCriteria 
Details  1. Pregnant Woman With Under Developed Fetus Or With Malformation
2. Pregnant Woman With Acute Fetal Distress
3. Pregnant Woman With Multiple Pregnancy
4. Pregnant Woman With Cardiac Disorder Moderate To Lung Disorder Moderate To Severe Psychopathologies Pregnancy Induced Hypertension coagulopathies Allegic To Drugs Local Infection At Site Spinal Deformities
5. Patients Should Not Be A Part Of Any Other Study 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Asses And Compare Anxiolytic Effect Of With Or Without Midazolam In Patients Of Cesarean Section  90 Minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1. To Asses And Compare APGAR Ramsay Sedation Scale Recall Of Moments Of Birth In Study Groups
2. To Determine The Change In Hemodynamic Parameter HR SBP DBP SPO2
3.Proportion Of Cases Of Complication (IF Any) 
90 Minutes 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
This study is a randomized,double blind,interventional controlled study.The aim of study : To deyermine anxiolytic efficacy of midazolam administered pre operatively,in patients of cesarean section and to evaluate whether its administration impacts neonatal vitality,maternal consciousness and recall of moment the baby was born.

patient fulfilling inclusion criteria will be selected 
patient will be received in the OT,patients will be identified PAC,informed written consent and fasting status will be checked
following data will be recorded - age ,weight,height,parity,caesarean deliveries , gestational age 
pre operative vitals will be recorded (HR,SBP.DBP,SPO2)
18G iv line will be secured in upper limb and ringer lactate solution will be started
perform visual facial anxiety scale score for level of anxiety assessment 
randomisation and allocation
 GROUP A    (n=80)                                                                   GROUP B (n=80)
MIDAZOLAM GROUP                                                 CONTROL GROUP
will receive single intravenous bolus                            will receive intravenous an identical volume of 0.9%saline as placebo solution
dose of midazolam of 0.0125mg/kg 
administration of solution occur in the interval between randiomisation and positioning the patient for spinal anaesthesia
spinal anaesthesia performed with patient in a sitting position with a 25G quincke type needle by injection 0.5% hyperbaric bupivacaine 2ml
visual facial anxiety scale score assessment at 5 min, 15min,15min
5 minutes after level of sedation by ramsay scale
apgar score at 1st and 5 th minute will be noted
intraoperative vital parameters will be recorded at 5 min interval 
at the last, the mother will be asked about recall of moments of birth(at time of presentation and 90 minutes after time of birth)
 
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