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
|
|
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
|
|
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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