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CTRI Number  CTRI/2022/01/039726 [Registered on: 25/01/2022] Trial Registered Prospectively
Last Modified On: 20/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of drug Dexmedetomidine and Fentanyl as an adjuvant to Ropivacaine in epidural space for post operative pain relief in abdominal hysterectomy patients. 
Scientific Title of Study   COMPARISON OF DEXMEDETOMIDINE AND FENTANYL AS AN ADJUVANT TO ROPIVACAINE FOR EPIDURAL ANALGESIA IN ABDOMINAL HYSTERECTOMY REGARDING QUALITY OF POSTOPERATIVE ANALGESIA.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Puja Kumari 
Designation  Junior Resident 
Affiliation  Rajendra Institute of Medical Sciences, Ranchi 
Address  3rd floor , Department of anaesthesiology,Rims,Bariatu,Ranchi.

Ranchi
JHARKHAND
834009
India 
Phone  9972289203  
Fax    
Email  drpujakumari2502@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukesh Kumar 
Designation  Associate Professor 
Affiliation  Rajendra Institute of Medical Sciences, Ranchi 
Address  Department of anaesthesiology,Rims,Bariatu, Ranchi.

Ranchi
JHARKHAND
834009
India 
Phone  9955360544  
Fax    
Email  drkmukesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Puja Kumari 
Designation  Junior Resident 
Affiliation  Rajendra Institute of Medical Sciences, Ranchi 
Address  3rd floor, Department of anaesthesiology,Rims,Bariatu,Ranchi.

Ranchi
JHARKHAND
834009
India 
Phone  9972289203  
Fax    
Email  drpujakumari2502@gmail.com  
 
Source of Monetary or Material Support  
Rajendra institute of medical sciences 
 
Primary Sponsor  
Name  Rajendra Institute of medical sciences 
Address  Department of anesthesiology,Rims ,Ranchi 
Type of Sponsor  Government medical college 
 
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 
Dr Shio Priye  Rajendra institute of medical sciences  Room no 61,Department of anaesthesiology,Rims,Bariatu.
Ranchi
JHARKHAND 		 9986743162

shiopriye@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajendra institute of medical sciences,Ranchi  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 
Intervention  Dexmedetomidine  Group RD: Ropivacaine (0.125 %) +1µg/ml Dexmedetomidine @7ml/hr for 24 hours. 
Comparator Agent  Fentanyl  Group RF: Ropivacaine (0.125%) +2µg /ml Fentanyl @7ml/hr for 24 hrs 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  All patients with ASA status type I, II aged between 30-60 who will be undergoing abdominal hysterectomy surgeries. 
 
ExclusionCriteria 
Details  a) All patients who are not willing to consent, b) All patients who have a history of allergies to any of the drugs used in the study, c) Bleeding diathesis, uncontrolled hypertension and heart rate. 
 
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 
The degree of motor block will be assessed by the Modified Bromage scale  1 hr-24hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Post-operative pain scores will be recorded using visual analogue scale (VAS) ranging from 0 to 10  1 hr -24hrs 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   15/02/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 (Others) -  Publication

  6. For how long will this data be available start date provided 20-01-2022 and end date provided 20-01-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This prospective, randomised controlled, double blind study will be conducted on 60 patients belonging to the ASA physical status 1 or 2, aged 30 - 60 years posted for elective abdominal hysterectomy.
Pre-anaesthetic check up will be done a day before surgery including a detailed history,a thorough physical and systemic examination. Routine investigations will include CBC, routine urine test, ECG, serum urea, serum creatinine, blood sugar and chest radiograph. In the operating room standard monitoring will be established (ECG, Non-invasive Blood pressure, pulse oximetry) and baseline measurements will be recorded. Under aseptic precautions, epidural catheter will be placed using 18 G Touhy needle with patients in the sitting position in L3-L4 interspace and location of epidural space will be confirmed using loss of resistance technique. A test dose of 3 ml of 2% Lignocaine with adrenaline will be administered into epidural space and thereafter epidural catheter will be secured 3 to 5 cm into epidural space and patient will be placed in the supine position. Heart rate, mean arterial pressure, SPO2 will be recorded using standard monitors before and after epidural test dose. General anaesthesia will be induced with Propofol (1.5-2mg/kg) + Succinyl choline(1.5mg/kg) + Fentanyl (2 µg/kg) and maintained with O₂, N₂O and Isoflurane. Muscle relaxation will be done with vecuronium 4mg and then 1mg intermittently. The respective drugs depending on the group allocated will be given by epidural infusion at the rate of 7ml/hr (Ropivacaine (0.125 %) +1µg/ml Dexmedetomidine or Ropivacaine (0.125%) +2µg /ml Fentanyl) into the epidural space 1hr after the skin incision using syringe pump. After extubation, the patient will be put on PCEA pump with study drug with background infusion
of 5ml/hr(Ropivacaine (0.125 %) +1µg/ml Dexmedetomidine or Ropivacaine (0.125%) +2µg /ml Fentanyl), demand bolus dose of 2ml, lock-out interval of 10 min (Maximum dose=10ml/hr). The degree of motor block will be assessed by the Modified Bromage scale:
 Bromage 0 – able to perform a full straight leg raise over the bed for 5 sec
 Bromage 1 – unable to perform the leg raise but can flex the leg on the knee articulation.
 Bromage 2 – unable to flex the knee but can flex the ankle.
 Bromage 3 – unable to flex ankle but can move the toes.
 Bromage 4 – unable to move toes (total paralysis).
 Post-operative pain scores will be recorded using visual analogue scale (VAS) ranging from 0 to 10 (0 – no pain ,10- worst pain ever) at 0,1,2,4,8,12,16,20,24 hours.
Patients with breakthrough pain will be given 25µg Fentanyl IV bolus. Rescue analgesia requirement will be noted and side effects if any will be addressed accordingly.

 
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