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CTRI Number  CTRI/2017/12/011024 [Registered on: 28/12/2017] Trial Registered Retrospectively
Last Modified On: 27/12/2017
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   Evaluation of the role of Dexmedetomidine in reducing pain after surgery for brain tumors. 
Scientific Title of Study   Effect of Dexmedetomidine as an adjuvant to Bupivacaine for scalp blocks in supratentorial craniotomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Prasad Hrishi P 
Designation  Assistant Professor 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology 
Address  Department of Anesthesiology Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum, Kerala

Thiruvananthapuram
KERALA
695011
India 
Phone  9495239765  
Fax    
Email  drajay@sctimst.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajay Prasad Hrishi P 
Designation  Assistant Professor 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology 
Address  Department of Anesthesiology Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum, Kerala

Thiruvananthapuram
KERALA
695011
India 
Phone  9495239765  
Fax    
Email  drajay@sctimst.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Ajay Prasad Hrishi P 
Designation  Assistant Professor 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology 
Address  Department of Anesthesiology Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum, Kerala

Thiruvananthapuram
KERALA
695011
India 
Phone  9495239765  
Fax    
Email  drajay@sctimst.ac.in  
 
Source of Monetary or Material Support  
No source of external funding disclosed. The study is to be performed at Sree Chitra Tirunal Institute for Medical Sciences and Technology Hospital 
 
Primary Sponsor  
Name  Sree Chitra Tirunal Institute for Medical Sciences and Technology 
Address  Department of Anesthesiology Sree Chitra Tirunal Institute of Medical Sciences and Technology Trivandrum Kerala 695011 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Gautham N S  Senior Resident Department of Anesthesiology Sree Chitra Tirunal Institute of Medical Sciences and Technology Trivandrum Kerala 695011 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Prasad Hrishi P  Sree Chitra Tirunal Institute for Medical Sciences and Technology  Neurosurgery OT complex, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Thiruvananthapuram
KERALA 		 9495239765

drajay@sctimst.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Consenting, non pregnant, non lactating adult patients coming for supratentorial craniotomy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bupivacaine  Bilateral scalp block with injection of 2 ml of 0.5% Bupivacaine at each of the following nerves; Supratrochlear, Supraorbital, Zygomaticotemporal, Auriculotemporal, Great auricular, Lesser occipital and Greater occipital nerves, will be given following indutcion of anesthesia. 
Intervention  Dexmedetomidine as an adjuvant to scalp block  Dexmedetomidine 100 micrograms to be added to a solution containing 28ml 0.5% Bupivacaine, for scalp block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Consenting, non pregnant, non lactating adult patients coming for supratentorial craniotomy will participate in the study. Minors, neonates, persons incompetent to give informed consent, prisoners, normal/healthy volunteer, student, staff of the institute are not planned to be included in the study. 
 
ExclusionCriteria 
Details  Previous craniotomy,Hypertensive patients, Diabetics, Pre-operative GCS < 15/15, Known allergy to local anaesthetics, Pregnancy, Scalp infection, Coagulopathy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of post-operative analgesia, defined as the time when the Visual Analog Score is greater than or equal to 4 in the post operative period  Visual Analog Score to be assessed post operatively at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours and 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
Intra-operative anaesthetic requirement; Number of additional doses of Fentanyl required to ensure adequate intraoperative analgesia  At the end of surgery 
Post-operative analgesia   VAS score 
Post operative sedation score; Ramsay Sedation Scale  Every hour for 6 hours post operatively 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3 
Date of First Enrollment (India)   01/10/2016 
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)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Primary purpose of the study is to evaluate the effect of adding Dexmedetomidine as an adjuvant to scalp block, with respect to its effect on the duration of scalp block.Dexmedetomidine as an adjuvant to scalp block will prolong the duration of scalp block, thereby increasing the duration of the block, and therefore, decreasing the requirement of analgesic use in the post operative period.  
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