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CTRI Number  CTRI/2019/11/022038 [Registered on: 18/11/2019] Trial Registered Prospectively
Last Modified On: 15/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two drug combinations for sedation and pain relief for bone biopsy under CT-scan. 
Scientific Title of Study   Comparison of ketamine dexmedetomidine combination with fentanyl-dexmedetomidine combination for procedural sedation and analgesia during CT guided core biopsy: a randomized 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  Dr Shagun Bhatia Shah 
Designation  Consultant Anaesthesiology 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room;Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini ; New Delhi -110085

North West
DELHI
110085
India 
Phone  9891769779  
Fax    
Email  shah.shagun@rgcirc.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Shagun Bhatia Shah 
Designation  Consultant Anaesthesiology 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room;Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini ; New Delhi -110085

North West
DELHI
110085
India 
Phone  9891769779  
Fax    
Email  shah.shagun@rgcirc.org  
 
Details of Contact Person
Public Query  
Name  Dr Shagun Bhatia Shah 
Designation  Consultant Anaesthesiology 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room;Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini ; New Delhi -110085

North West
DELHI
110085
India 
Phone  9891769779  
Fax    
Email  shah.shagun@rgcirc.org  
 
Source of Monetary or Material Support  
Rajiv Gandhi Cancer Institute and research Centre; Sector -5; Rohini; Delhi-110085 
 
Primary Sponsor  
Name  Dr Shagun Bhatia Shah 
Address  H.No-174-175; ground floor ;pocket -17; sector-24; Rohini- Delhi-110085 
Type of Sponsor  Other [[Being the Principal Investigator]] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Rajiv Chawla  Rajiv Gandhi Cancer Institute and Research Centre Sector-5 Rohini Delhi-110085 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shagun Bhatia Shah  Rajiv Gandhi Cancer Institute and Research Centre  Operation Theatre no:6;Department of Anaesthesia;Operation Theatre Division;Third Floor ;Old Building;Sect or-5;Rohini;Delhi-11008 5
North West
DELHI 		 9891769779

shah.shagun@rgcirc.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board of Rajiv Gandhi Cancer Institute and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C800||Disseminated malignant neoplasm, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fentanyl  Intravenous bolus dose of fentanyl (0.5µg/kg) 1 min prior to LA infiltration by the interventionalist. A repeat dose of intravenous fentanyl 0.25 µg/kg at 20 mins and 40 minutes post beginning of Bx, the total duration of procedure being 75 minutes  
Intervention  Ketamine  Intravenous bolus dose of ketamine (0.5mg/kg; analgesic dose) 1 min prior to LA infiltration by the interventionalist. A repeat dose of intravenous ketamine 0.25 mg/kg at 20 mins and 40 minutes post beginning of Bx, total duration of the procedure being 75 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I- II patients
Weight 40-80 kg
Either Sex
Undergoing CT-guided core biopsy/RFA
 
 
ExclusionCriteria 
Details  Patients with raised intracranial tension
Pre-existing psychiatric disorder
Opioid dependence
Geriatric age group(Age>60 yrs)
Bradycardia (Heart Rate< 60/min)
 
 
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 
Heart rate; Mean Arterial Pressure;Pain response;Respiratory rate;Arterial Oxygen Saturation  0 min(Baseline);10mins (After dexmedetomidine loading dose),14mins (1 minute post ketamine/ fentanyl boluses);15 mins (At Biopsy);25 mins (After 10 minutes of procedure);35 mins (After 20 minutes of procedure); 45 mins (After 30 minutes of procedure); 55 mins (After 40 minutes of procedure);65 mins (After 50 minutes of procedure);75 mins (At end of procedure) 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analog Score(VAS)at rest;Visual Analog Score(VAS)on coughing;
Post-Operative nausea/Vomiting(PONV);
Orientation;
Aldrete Score 		 After 75 mins(At The end of procedure) 
 
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   N/A 
Date of First Enrollment (India)   19/11/2019 
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 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)?  

Brief Summary   This study is a prospective, interventional, double blind, randomised, parallel arm, active controlled, single centric study comparing two anaesthetic drug combinations for providing sedation and analgesia in 60 adult patients of either sex undergoing either CT-guided core biopsy or radiofrequency ablation in metastatic cancer patients.The patients shall be randomly allocated to either Group K( Ketamine+ Dexmedetomidine) or Group F(Fentanyl + Dexmedetomidine). All patients shall be premedicated with midazolam ( 0.03mg/kg) and shall receive dexmedetomidine infusion(1mg/kg loading dose over 10 minutes followed by 0.5mg/kg maintenance infusion). Dexmedetomidine is expected to neutralize the tachycardia, hypertension and salivary secretions and hallucinations produced by ketamine whereas ketamine is expected to neutralize the bradycardia , hypotension and dry mouth due to ketamine. Hence this combination i expected to provide maximal analgesia with minimum complications and may prove to be the ideal combination for procedural sedation. The primary outcome measures would be the heart rate , mean arterial pressure, response to pain, respiratory rate and arterial oxygen saturation at various time points( Baseline; After dexmedetomidine loading dose; 1 minute after ketamine/fentanyl bolus; on Biopsy; After 10 minutes of procedure; After 20 minutes of procedure; After 30 minutes of procedure; After 40 minutes of procedure; After 50 minutes of procedure; At the end of procedure). The secondary outcome measures would be the post-operative visual analog score (VAS) at rest and on coughing, postoperative nausea/ vomiting(PONV), orientation of the patient and Aldrete score at the end of the procedure. 
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