| CTRI Number |
CTRI/2024/01/061650 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effectiveness of two local anaesthetic drugs as an additive in epidural labour analgesia |
|
Scientific Title of Study
|
A comparative study on the efficacy of Dexmedatomidine and Fentanyl as a local anaesthetic adjuvant to Levobupivacaine 0.125% in epidural labour analgesia- A randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUKESH |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Thiruporur, Guduvancherry Main Road, Ammapettai, Nellikuppam, Kancheepuram, Tamil Nadu
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9677042039 |
| Fax |
|
| Email |
mukeshdhana96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KRISHNA PRASAD T |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Thiruporur, Guduvancherry Main Road, Ammapettai, Nellikuppam, Kancheepuram, Tamil Nadu
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9944579455 |
| Fax |
|
| Email |
drkrishna86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KRISHNA PRASAD T |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Thiruporur, Guduvancherry Main Road, Ammapettai, Nellikuppam, Kancheepuram, Tamil Nadu
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9944579455 |
| Fax |
|
| Email |
drkrishna86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Thiruporur, Guduvancherry Main Road, Ammapettai, Nellikuppam, Kancheepuram, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Mukesh |
| Address |
No 26/17, Hussain Subedhar Street, Alandur, Chennai 600016 |
| Type of Sponsor |
Other [Self] |
|
|
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 Mukesh |
Shri Sathya Sai Medical College and Research Institute |
First Floor OT Complex, Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Thiruporur, Guduvancherry Main Road, Ammapettai, Nellikuppam, Kancheepuram, Tamil Nadu
Kancheepuram
TAMIL NADU |
9677042039
mukeshdhana96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF HUMAN ETHICAL 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 |
| Comparator Agent |
Addititive:Dexmedetomidine
Addititive:Fentanyl |
Dexmedetomidine- 0.5mcg/Kg
Fentanyl-2mcg/ml.
duration of 3-6 hours |
| Intervention |
Levobupivacaine |
Levobupivacaine 0.125% in epidural labor analgesia,
for 3- 6 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age> 18 years
Full term primigravida with singleton pregnancy (>37 weeks gestation) and required labor analgesia in hospital
Patients who met the criteria for American Society of Anaesthesiology physical status I/II
Patients willing to participate in the trial |
|
| ExclusionCriteria |
| Details |
1)Severe Heart, Lung, Liver and Kidney diseases,hemorraghic diseases or other systemic diseases
2)Known genteic or congenital malformations, fetal growth restrictions or Oligohydramnios.
3)Lower abdominal or urological surgery history, spinal deformity or previous spinal surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE ANALGESIC EFFECTS IN BOTH THE GROUPS FOR THE MOTHER |
Intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COMPARING THE EFFECTIVENESS OF DEXMEDETOMIDINE AND FENTANYL AS A LOCAL ANESTHETIC ADJUVANT TO LEVOBUPIVACAINE IN EPIDURAL LABOR ANELGESIA |
Intraoperative period. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
22/01/2024 |
| 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="1"
Months="6"
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
|
A Comparative study on the efficacy of Dexmedetomidine and Fentanyl as a local anesthetic adjuvant to Levobupivacaine 0.125% in epidural labor analgesia : Randomized controlled study in a tertiary care hospital kancheepuram district
PRIMARY OBJECTIVE To compare the analgesic effects of two drugs in epidural anesthesia in antenatal mother
SECONDARY OBJECTIVE To compare the variables like, Heart rate, Mean blood pressure, and Spo2 Adverse reactions of parturient women
DATA COLLECTION PROCESS: Pre anesthetic checkup will be done and those patients who fit into the inclusion criteria will be taken up for the study. Study will be started after ethical committee and institutional committee approval . CTRI registration will be done before enrolling patient to the study. • NPO of 6 hours for solid foods and 4 hours for liquids (prior to the procedure) will be ensured in all the patients. They would be pre medicated in the night before surgery followed by Inj. Pantoprazole 40 mg IV on the morning of surgery. IV access with 18G venflon secured in all patients. Monitors- Pulse oximeter, NIBP, ECG. ETCO2, Baseline values will be noted. • Patients will be randomized into two groups 1 and 2 by the computer-generated technique.
• Group 1 includes 12 ml of 0.125% levobupivacaine with 0.5mcg/kg dexmedetomidine • Group 2 includes 12 ml of 0.125% levobupivacaine with 2mcg/ml fentanyl • Patients will be monitored for the following • Blood pressure and heart rate will be monitored noninvasively. • Intra and postoperative complications if any will be noted.
|