| CTRI Number |
CTRI/2024/10/075255 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different doses of dexmedetomidine drug as adjuvant to ropivacaine drug in epidural labor analgesia in pregnant women. |
|
Scientific Title of Study
|
To compare the efficacy and safety of two different doses of dexmedetomidine 0.2 mcg per ml and 0.5 mcg per ml as adjuvant to ropivacaine 0.2 percent for epidural labor analgesia. A prospective randomized control trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sagar P Kanani |
| Designation |
Resident Doctor Anesthesiology |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
Department of anaesthesia, Sir T hospital, jail road, Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9510080163 |
| Fax |
|
| Email |
kananisagar15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Shah |
| Designation |
Associate Professor of Anesthesiology |
| Affiliation |
Government medical College |
| Address |
Associate Professor, Dept. of
Anesthesiology, Government
Medical College,
Bhavnagar-364001, Gujarat.
Sir T. General Hospital jail Road Kalanala Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215252 |
| Fax |
|
| Email |
shah.komal212@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Shah |
| Designation |
Associate Professor of Anesthesiology |
| Affiliation |
Government medical College |
| Address |
Associate Professor, Dept. of
Anesthesiology, Government
Medical College,
Bhavnagar-364001, Gujarat.
Sir T. General Hospital jail Road Kalanala Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215252 |
| Fax |
|
| Email |
shah.komal212@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anesthesiology department Government Medical College Bhavnagar Gujarat India 364001 |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
SIR TAKHTSINHJI GENERAL HOSPITAL, JAIL ROAD, KALANALA BHAVNAGAR |
| 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 Sagar Kanani |
Sir T. General Hospital jail Road Kalanala Bhavnagar |
Labor room, obstetrics and gynaecology department
Bhavnagar
GUJARAT |
9510080163
Kananisagar15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O759||Complication of labor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomedine 0.2 mcg/ml |
EFFICACY AND SAFETY OF 0.2 MCG/ML DOSE OF DEXMEDETOMIDINE AS ADJUVANT TO ROPIVACAINE FOR EPIDURAL LABOR ANALGESIA.
TOTAL DURATION OF INTERVENTION : 4-8 HOURS. |
| Comparator Agent |
Dexmedetomidine 0.5 mcg/ml |
EFFICACY AND SAFETY OF 0.5 MCG/ML DOSE OF DEXMEDETOMIDINE AS ADJUVANT TO ROPIVACAINE FOR EPIDURAL LABOR ANALGESIA.
TOTAL DURATION OF INTERVENTION : 4-8 HOURS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 18 to 30 years
2. Term primi gravida, cephalic singleton pregnancy
3. Uterine contractions at least once in 5 minutes with cervical dilatation 3 to 4 cm |
|
| ExclusionCriteria |
| Details |
1. Patient having history of allergy to Local anesthetic agent
2. Patient having preterm labor, pre-eclampsia, eclampsia, thyroid disorder, cardiomyopathies, multiple
pregnancy, previous LSCS, Abnormal lie, antepartum hemorrahge, morbid obesity, severe anemia,
hemodynamic instability
3. Any psychiatric or neurological disorder or altered mental status |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To compare the quality of pain relief using VAS (Visual Analogue Scale) score.
|
Before bolus
At 10 min of bolus
At 20 min of bolus
At 30 min of bolus
At 1 hour of bolus
At 1.5 hour of bolus
At 2 hour of bolus
At 2.5 hour of bolus
At 3 hour of bolus
At 3.5 hour of bolus
At 4 hour of bolus
Every half hourly till expulsion of placenta |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare hemodynamic parameters changes(pulse, blood pressure, spo2) during labor
2. To compare duration of progression of 1
st
, 2
nd and 3
rd stage of labor.
3. To compare total dose of ropivacaine(0.2%) with dexmedetomidine required for labor analgesia
4. To compare fetal heart sound during labor.
5. To compare the percentage(%) of instrumental delivery(including Cesarean section)
6. To compare the degree of motor blockade, if present, using modified Bromage scale (Grade 1-4)
7. To compare sedation in mother using Ramsay Sedation Scale(RSS)
8. To compare the neonatal outcome in the form of APGAR score after delivery of baby at 1 minute and 5
minute
9. To compare maternal satisfaction using likert scale
10. To compare obstetrician satisfaction likert scale |
Before bolus
At 10 min of bolus
At 20 min of bolus
At 30 min of bolus
At 1 hour of bolus
At 1.5 hour of bolus
At 2 hour of bolus
At 2.5 hour of bolus
At 3 hour of bolus
At 3.5 hour of bolus
At 4 hour of bolus
Every half hourly till expulsion of placenta |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/10/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Child birth is natural, memorable yet most painful experience of the women. Throughout pregnancy, painless Braxton Hicks contractions with simultaneous hardening of uterus occur. As the labor progresses, these contractions change its character, become more powerful, intermittent and are associated with pain. Pain more often felt in front of the abdomen or radiating toward thigh. • Ropivacaine, an amide local anesthetic which is selective for sensory fibers and preserving motor thus produce true walking epidural, can be used successfully. • Local anesthetic solutions in very low doses with alpha-2 agonist as an adjuvant can be used safely to prolong effect of local anesthetic in labor analgesia.
Pain relief is fundamental right parturient. pain relief in labor has always been surrounded with myth and misbelief. • Amongst all, epidural analgesia remained the gold standard. • As newer local anesthetic drug like ropivacaine will provide pain relief in labor without affecting motor fibers thus provide true walking epidural. |