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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  
NIL 
 
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  
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 
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  
Status 
Not Applicable 
 
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.

 


 
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