FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/05/052458 [Registered on: 10/05/2023] Trial Registered Prospectively
Last Modified On: 09/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare Intrathecal Dexmeditomidine 10mcg versus Fentanyl 25mcg when added with Hyperbaric 0.75% Ropivacaine 18.75mg as additive in Spinal Anaesthesia in Patients Undergoing Infraumbilical Surgeries 
Scientific Title of Study   Comparative Study of Effects of Intrathecal Dexmeditomidine versus Fentanyl as adjuvants to Hyperbaric 0.75% Ropivacaine in Patients Undergoing Infraumbilical Surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chunnilal 
Designation  PG Student 
Affiliation  Dr. S.N.Medical Collage Jodhpur 
Address  Department of Anaesthesia
MDM Hospital Hostel no.7 Jodhpur
Jodhpur
RAJASTHAN
343003
India 
Phone  08209516803  
Fax    
Email  drclchoudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M L Tak 
Designation  Senior professor 
Affiliation  Dr. S.N.Medical Collage Jodhpur 
Address  Department of Anaesthesia
MDM Hospital Jodhpur
Jodhpur
RAJASTHAN
343003
India 
Phone  08209516803  
Fax    
Email  Mdmhjodhpur@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chunnilal 
Designation  PG Student 
Affiliation  Dr. S.N.Medical Collage Jodhpur 
Address  Department of Anaesthesia
MDM Hospital Jodhpur Main OT
Jodhpur
RAJASTHAN
343003
India 
Phone  08209516803  
Fax    
Email  drclchoudhary@gmail.com  
 
Source of Monetary or Material Support  
MDRU Jodhpur,Dr.s.n.medical collage Jodhpur and attached Hospitals (MDM Hospital Jodhpur,MGH Hospital and Ummaid Hospital Jodhpur) 
 
Primary Sponsor  
Name  Multidisciplinary Research Unit Dr SNMC Jodhpur 
Address  Multidisciplinary Research Unit (MDRU) Dr S.N.Medical Collage Jodhpur 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chunnilal  MDM Hospital Jodhpur  Department of Anaesthesia Operation Theater
Jodhpur
RAJASTHAN 		 8209516803

drclchoudhary@gmail.com 
Dr Chunnilal  MGH Hospital Jodhpur  Department of Anaesthesia Operation theater
Jodhpur
RAJASTHAN 		 08209516803

Mdmhjodhpur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee Dr S.N.Medical collage Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ropivacaine alone  2.5ml of Hyperbaric Ropivacaine 0.75% + normal saline 0.5ml 
Intervention  Ropivacaine with Dexmeditomidine  2.5ml of Hyperbaric Ropivacaine 0.75% + 10mcg Dexmeditomidine 
Intervention  Ropivacaine with Fentanyl  2.5ml of Hyperbaric Ropivacaine 0.75% + 25mcg Fentanyl 0.5ml 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult Patients of either sex ,aged between 18 and 60 years who will be Undergoing for infraumbilical surgeries
Patients belonging to ASA-PS class1 and class 2
Patients without any severe comorbid diseases 
 
ExclusionCriteria 
Details  Patients having any absolute contraindications for Spinal Anaesthesia such as patient not willing, raised intracranial pressure, severe hypovolemia, bleeding diathesis,local site infection,severe cardiac , respiratory,and CNS diseases are excluded from the study
Pregnant females,uncontrolled diabetes and hypertension
Patients with body mass index greater than 30kg/m2
Patients shorter than 150cm 
 
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 
Duration of Analgesia Postoperatively-VAS (visual analogue score) VAS equal or greater than 4 or time of first Analgesia request  Time in minutes-0,15,30,60,90,120,150,180,210,240,270,300 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Objectives
Time of onset and duration of Sensory blockade
Time of onset and duration of motor blockade
Maximum Sensory blockade attained and time taken for the same
Time taken for two segment Sensory regression
Quality of motor blockade and time taken for maximum Motor blockade
To compare the hemodynamic changes and side effects such as sedation, nausea and vomiting, shivering and respiratory depression 		 Time in minutes-0,1,5,10,20,30,40,50,60,70,80,90,120,150,180,210,240,270,300,330,360,390,420,450 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   10/05/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drclchoudhary@gmail.com].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Present Study Topic: Comparative study of Effects of Intrathecal Dexmeditomidine versus Fentanyl as adjuvants to Hyperbaric 0.75% Ropivacaine in Patients Undergoing Infraumbilical Surgeries
Aims and Objectives:
Primary Objectives:To compare the duration of Analgesia in the Intrathecal Dexmeditomidine (RD) , Fentanyl (RF),Control group (RC)
Secondary Objectives: following parameters will be compared in three groups e.g time of onset , duration and quality of Sensory blockade and Motor blockade, hemodynamic changes and side effects.
Study type: Randomized comparative study
Source of data: the study will be carried out in the department of Anaesthesiology,Dr S.N.Medical College and associated hospitals(MDM hospital,MGH hospital and Ummaid Hospital Jodhpur).
Study Duration:6months or till sample size achieved.
Sample size: Total 90 Patients (30 Patients in each group)
Study population: Study population will be randomly divided by computer generated random table and group allocation will be done by shuffled closed envelope technique into three equal groups.
1. Group(RF)(n=30): 2.5ml of 0.75% Hyperbaric Ropivacaine+ 25mcg Fentanyl (0.5ml)
2. Group (RD)(n=30): 2.5ml of 0.75% Hyperbaric Ropivacaine+10mcg Dexmeditomidine
3. Group (RC)(n=30): 2.5ml of 0.75% Hyperbaric Ropivacaine+0.5ml Normal saline
Inclusion Criteria and Exclusion criteria:as mentioned in above format.
Randomization:the each Patients will be received 3ml it the study drug according to randomization. Double blinding technique will be applied.hence the patient and the observer will be blinded to the study drug.
Intraoperatively and Postoperatively monitoring will be noted .
Statistical analysis:Data will be entered into Microsoft Excel data sheet and will be analysed using SPSS 22 version software.


 
Close