CTRI Number |
CTRI/2021/09/036511 [Registered on: 15/09/2021] Trial Registered Prospectively |
Last Modified On: |
14/09/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Fentanyl vs Dexmedetomidine with intrathecal levobupivacaine in elective cesarean section |
Scientific Title of Study
|
Intrathecal Fentanyl versus Intrathecal Dexmedetomidine as an adjuvant to Isobaric Levobupivacaine in Cesarean section in a Tertiary care center in Chengalpet district-Randomised control trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
MOHAMED BASITH |
Designation |
post gradate student |
Affiliation |
Shri sathya sai medical college and research institute. |
Address |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE,THIRUPORUR GUDUVANCHERRY MAIN ROAD,CHENGALPET TALUK, KANCHEEPURAM DISTRICT DEPARTMENT OF ANAESTHESIOLOGY,
2ND FLOOR OT COMPLEX,
SHRI SATHYA SAI MEDICAL COLLEGE
CHENNAI Kancheepuram TAMIL NADU 603108 India |
Phone |
9944882312 |
Fax |
|
Email |
sweetbasith@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrDilip KumarG |
Designation |
Associate Professor |
Affiliation |
Shri sathya sai medical college and research institute. |
Address |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE,THIRUPORUR GUDUVANCHERRY MAIN ROAD,CHENGALPET TALUK, KANCHEEPURAM DISTRICT DEPARTMENT OF ANAESTHESIOLOGY,
2ND FLOOR OT COMPLEX,
SHRI SATHYA SAI MEDICAL COLLEGE
CHENNAI Kancheepuram TAMIL NADU 600130 India |
Phone |
909490243 |
Fax |
|
Email |
dilipko@gmail.com |
|
Details of Contact Person Public Query
|
Name |
MOHAMED BASITH |
Designation |
post gradate student |
Affiliation |
Shri sathya sai medical college and research institute. |
Address |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE,THIRUPORUR GUDUVANCHERRY MAIN ROAD,CHENGALPET TALUK, KANCHEEPURAM DISTRICT DEPARTMENT OF ANAESTHESIOLOGY,
2ND FLOOR OT COMPLEX,
SHRI SATHYA SAI MEDICAL COLLEGE
CHENNAI Kancheepuram TAMIL NADU 603108 India |
Phone |
9944882312 |
Fax |
|
Email |
sweetbasith@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
MOHAMED BASITH |
Address |
SHRI SATHYA SAI MEDICAL COLLEGE AND RSEARCH INSTITUTE AMMAPETTAI GUDUVANCHERRY MAIN ROAD, CHENGALPET TALUK, KANCHEEPURAM DISTRICT |
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 |
MOHAMED BASITH |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE,DEPARTMENT OF ANAESTHESIOLOGY-2ND FLOOR OT COMPLEX, THIRUPORUR GUDUVANCHERRY MAIN ROAD, CHENGALPET TALUK, AMMAPETTAI, KANCHEEPURAM DISTRICT Kancheepuram TAMIL NADU |
9944882312
sweetbasith@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Shri sathya sai medical college ethical committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
DEXMEDETOMIDINE AS AN ADJUVANT TO ISOBARIC LEVOBUPIVACAINE . |
GROUP LD WILL RECEIVE PATIENT WILL RECEIVE 2ML OF 0.5% LEVOBUPIVACAINE WITH DEXMEDETOMIDINE 5MCG INTRATHECALLY. PATIENTS WILL BE MONITORED INTRAOPERATIVELY FOR EVERY 5 MINUTES FOR FIRST 20 MINUTES THEN FOLLOWED BY EVERY 10 MINUTES TILL THE SURGERY GETS OVER. |
Intervention |
FENTANYL AS AN ADJUVANT TO ISOBARIC LEVOBUPIVACAINE |
GROUP LF WILL RECEIVE
2ML OF 0.5% LEVOBUPIVACAINE WITH FENTANYL 25MCG INTRATHECALLY .PATIENTS WILL BE MONITORED INTRAOPERATIVELY FOR EVERY 5 MINUTES FOR FIRST 20 MINUTES THEN FOLLOWED BY EVERY 10 MINUTES TILL THE SURGERY GETS OVER. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Female |
Details |
WOMEN WITH FULL TERM PREGNANCIES
WOMEN BELONGING TO ASA 1 AND 2 POSTED FOR ELECTIVE CESAREAN SECTION
AGE GROUP 18-35 YEARS |
|
ExclusionCriteria |
Details |
EMERGENCY CESAREAN SECTION
MATERNAL MEDICAL CO-MORBIDITIES
INFECTION AT NEEDLE SITE
REFUSAL TO SPINAL ANAESTHESIA
ALLERGIC TO LOCAL ANAESTHETICS AND ADJUVANTS
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
TO COMPARE THE DURATION OF POST OPERATIVE ANALGESIA OF LEVOBUPIVACAINE WITH FENTANYL VERSUS LEVOBUPIVACAINE WITH DEXMEDETOMIDINE |
18 MONTHS |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the intraoprative haemodynamic changes, level pf motor ad sensory blockade between the two groups |
18 MONTHS |
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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 4 |
Date of First Enrollment (India)
|
15/09/2021 |
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
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
After getting approval from the ethical committee, the patients who were willing for the study, fulfilling the criteria for the study will be included.The patients would be randomly divided into two groups by computer generated list of random numbers. Doses will be calculated after analyzing previous studies.Group 1 (LF) will receive 0.5% levobupivacaine 2ml + fentanyl 25 mcg.Group 2 (LD)will receive 0.5%levobupivacaine 2ml + dexmedetomidine 5 mcg.The patient as well as the anesthetist involved in the study will be blinded to the drug used. Separate independent anesthesiologist who otherwise will not be a part of the procedure will prepare the syringe with drugs and will hand it over to the attending anesthesiologist.On the day before the surgery patient will be assessed in the pre anaesthetic clinic. Patient will be kept NPO 8 hours before surgery. Pre medication with T.alprazolam 0.5 mg and inj.pantoprazole 40 mg IM will be given. Standared ASA monitoring like non invasive blood pressure , ECG, pulse oximetry are observed. Patients will be cannulated with 18 G intravenous cannula. Patients will be preloaded with 15 ml / kg of ringer lactate. Spinal will be given with the labeled syringe ,patient will be put in supine position and sensory level should be checked with pin prick method ,review of motor blocked is assessed with bromage scale .intraoperative parameters like BP, PR and spo2 will be recorded every 5minutes for the first 20 minutes then every 10 minutes till the end of the surgery. Pain score will be monitored by VAS score postoperatively patient will be observed for 24 hours for postoperative complications like nausea, vomiting ,pruritis, shivering, respiratory depression, hypotension, bradycardia. |