| 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
|
|
|
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
|
|
|
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) |