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CTRI Number  CTRI/2023/11/059618 [Registered on: 07/11/2023] Trial Registered Prospectively
Last Modified On: 22/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of fentanyl and midazolam in spinal anaesthesia in lower segment caesarean section patients 
Scientific Title of Study   A comparative study to evaluate efficacy of intrathecal fentanyl and intrathecal midazolam added as adjuvant to Bupivacaine 0.5 (heavy) in patients undergoing LSCs 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rutuja Gohad 
Designation  Junior Resident 
Affiliation  Acharya Vinobha Bhave Rural Hospital, JMNC 
Address  Department of Anaesthesiology, 2nd floor, new building, AVBRH, JNMC, Sawangi (Meghe), Wardha, Maharashtra, India 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9623126644  
Fax    
Email  rutujagohad29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Aruna Chandak 
Designation  Professor, Department of Anaesthesia, JNMC 
Affiliation  Acharya Vinobha Bhave Rural Hospital, JMNC 
Address  Department of Anaesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India 442001
AVBRH, JNMC, Sawangi (Meghe), Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India 
Phone  9422903551  
Fax    
Email  doctorchandak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rutuja Gohad 
Designation  Junior Resident 
Affiliation  Acharya Vinobha Bhave Rural Hospital, JMNC 
Address  Department of Anaesthesiology, 2nd floor, new building, AVBRH, JNMC, Sawangi (Meghe), Wardha, Maharashtra, India 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9623126644  
Fax    
Email  rutujagohad29@gmail.com  
 
Source of Monetary or Material Support  
Acharya Vinobha Bhave Rural Hospital, JNMC, Sawangi (Meghe), Wardha 442001 
 
Primary Sponsor  
Name  Acharya Vinobha Bhave Rural Hospital 
Address  Sawangi (Meghe), Wardha, Maharashtra, India 
Type of Sponsor  Private 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 
Rutuja Gohad  Acharya Vinobha Bhave Rural Hospital  Department of Anaesthesiology, JNMC, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India, 442001
Wardha
MAHARASHTRA 
9623126644

rutujagohad29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Institutional ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fentanyl  0.3 milliliters Fentanyl as adjuvant to Bupivacaine 0.5 % (heavy) while giving spinal anaesthesia 
Comparator Agent  Midazolam  0.3 milliliters Midazolam as adjuvant to Bupivacaine 0.5 % (heavy) while giving spinal anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Age between 18 to 35years
2. Patients undergoing cesarean section
3. Primi gravida with gestational age more than 37 weeks
4. Body mass index 20 to 29.9kg/meter square
5. Intact amniotic membrane
6. No history of bleeding tendency or coagulopathies or with any neuromuscular disorders or neurological diseases.
7. No previous uterine operations except cesarean sections
8. Living fetus
9. ASA II
10. Patients giving informed consent.
 
 
ExclusionCriteria 
Details  1. Patients who are multigravida, previous LSCS.
2. ASA CLASS 3 AND CLASS 4.
3. Patients refusal.
4. Patients with any co-morbities.
5. Patients with infection at the site of injection.
6. Patients with sensitivity to local anaesthetic agent, fentanyl and midazolam.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare and to evaluate efficacy of intrathecal Fentanyl and intrathecal Midazolam added as adjuvant to Bupivacaine 0.5% (heavy) in patients undergoing lower segment caesarean section  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the effect of fentanyl & midazolam on
intraoperative haemodynamics
The Onset & Duration of Sensory And Motor Block
To compare the role of fentanyl and midazolam as an adjuvant
for prevention of side effects
To access APGAR score
 
24 HOURS 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2 
Date of First Enrollment (India)   01/01/2024 
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="2"
Months="0"
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  

Spinal anaesthesia is preferred for lower abdominal and lower limb surgeries especially in cesarean sections due to long duration of analgesic effect, lesser thromboemolic events, because it is economical, easy to administer and fewer adverse effects in mother and infant. Bupivacaine is the most popular local anaesthetic for subarachnoid blockade because of less neurotoxicity. Intrathecal bupivacaine alone may be insufficient to provide prolonged post-operative analgesia, even with high sensory block. So, various adjuvants are used like ketamine, midazolam, clonidine, fentanyl, neostigmine etc. to prolong the effect of local anaesthetic. Fentanyl, an opioid, after intrathecal administration diffuses into epidural space and subsequently into the plasma, suggesting that it acts not only through spinal opioid receptors but also systemically. Fentanyl added to bupivacaine intrathecally provides better surgical anaesthesia.  Midazolam, a benzodiazepine is an anxiolytic and sedative, it when administered intrathecally has antinociceptive properties.

PRIMARY OBJECTIVE: COMPARISION OF DURATION OF ANALGESIA BETWEEN FENTANYL AND MIDAZOLAM AS AN ADJUVANT WITH BUPIVACAINE.

SECONDARY OBJECTIVE:

1. Compare the effect of fentanyl and midazolam on intraoperative haemodynamics. 

2. The Onset and Duration of Sensory And Motor Block . 

3. To compare the role of fentanyl and midazolam as an adjuvant for prevention of side effects like nausea, vomiting, shivering, pruritis. 

4. To access APGAR score.

METHODOLOGY: Patients for the study will be conducted on 60 patients fulfilling the inclusion criteria. Patients will be randomly allocated into 2 study groups who will be administered with the following combination of drugs.

GROUP A (n=30): 15 mcg Fentanyl intrathecal (0.3ml) with 2ml 0.5% Bupivacaine

GROUP B (n=30): 0.3 mg Midazolam intrathecal (0.3ml) with 2ml 0.5% Bupivacaine and the onset of duration of sensory and motor blockade , hemodynamic parameters, post operative analgesia and side effects will be recorded.


 
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