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CTRI Number  CTRI/2017/01/007667 [Registered on: 10/01/2017] Trial Registered Retrospectively
Last Modified On: 10/01/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of drug Dexmedetomidine as part of anaesthetic regimen during conduct of brain tumor surgery. 
Scientific Title of Study   Evaluation of Dexmedetomidine as anaesthetic adjunct to Propofol during Bispectral Index guided anaesthesia for cerebello-pontine angle surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhritiman Chakrabarti 
Designation  Senior Resident 
Affiliation  National Insitute of Mental Health and Neuro Sciences 
Address  Dept of Neuroanaesthesia, 3rd Floor, Faculty Block, NIMHANS, Hosur Road, Bangalore
#152, 4th Cross, 6th Main, JP Nagar 3rd Phase
Bangalore
KARNATAKA
560029
India 
Phone  8197781240  
Fax    
Email  rosesrred90@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dhritiman Chakrabarti 
Designation  Senior Resident 
Affiliation  National Insitute of Mental Health and Neuro Sciences 
Address  Dept of Neuroanaesthesia, 3rd Floor Faculty Block, NIMHANS, Hosur Road
#152, 4th Cross, 6th Main, JP Nagar 3rd Phase
Bangalore
KARNATAKA
560029
India 
Phone  8197781240  
Fax    
Email  rosesrred90@gmail.com  
 
Details of Contact Person
Public Query
 
Name  KR Madhusudan Reddy 
Designation  Professor and Head 
Affiliation  National Insitute of Mental Health and Neuro Sciences 
Address  Dept of Neuroanaesthesia, 3rd Floor Faculty Block, NIMHANS, Hosur Road

Bangalore
KARNATAKA
560029
India 
Phone  91-9480829730  
Fax    
Email  krmsr2000@yahoo.com  
 
Source of Monetary or Material Support  
Non Funded 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [None] 
 
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 Dhritiman Chakrabarti  Bangalore  National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore
Bangalore
KARNATAKA 
8197781240

rosesrred90@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cerebello-pontine angle tumour patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine; Propofol; Fentanyl  Intraoperative continuous infusion of Dexmedetomidine (0.5 micgm/kg/hr) + Fentanyl (0.5 micgm/kg/hr) + Propofol (via Target Controlled Infusion - Schnider model - titrated to maintain Bispectral Index between 40 - 60) 
Comparator Agent  Propofol; Fentanyl  Intraoperative continuous infusion of Fentanyl (0.5 micgm/kg/hr) + Propofol (via Target Controlled Infusion - Schnider model - titrated to maintain Bispectral Index between 40 - 60) 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing Cerebello-pontine angle surgeries with cranial nerve monitoring. 
 
ExclusionCriteria 
Details  1) Patients with evidence of sino-atrial nodal or atrio-ventricular nodal bradyarrhythmia on ECG, baseline heart rate < 50/min.
2) Patients with known history of hypertension and being treated with anti-hypertensive drugs.
3) Patients on tricyclic antidepressant, clonidine, monoamine oxidase-inhibitor therapy.
4) Patients with evidence of impaired hepatic/renal function according to past history or preoperative biochemistry parameters.
5) Need for intraoperative inotrope/vasopressor drug.
6) Allergy to egg/propofol
7) Absence of cranial nerve monitoring during surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Quantification of anaesthetic and analgesic sparing effect of dexmedetomidine.  End of anaesthesia. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Recovery from anaesthesia based on time to opening eyes, time to following commands and time to extubation after anaesthetic withdrawal.
2) Evaluate the effect propofol alone and propofol-dexmedetomidine combination on acid base status.
3) Observe the incidence of adverse haemodynamic events.
4) Observe the effect of these two anaesthetic techniques on postoperative sedation, nausea and vomiting, shivering and pain scores.
 
End of anaesthesia. 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Cerebello-pontine angle (CPA) surgeries tend to carry the surgeon’s knife uncomfortably close to the brainstem, putting various cranial nerves at risk for damage. For preventing this, cranial nerve monitoring using continuous electromyography (EMG) of the regional motor supply of the nerve or evoked potentials is utilized. It has been recommended in literature that propofol as a primary hypnotic component of anaesthesia would provide better conditions for cranial nerve monitoring compared to inhalational agents. High dose of propofol has certain undesirable effects as such as occasional delayed awakening, metabolic acidosis with increased lactate levels and myocardial depression causing hypotension. Dexmedetomidine has been used as an anaesthetic adjunct to propofol and has been shown to reduce propofol requirements, when used along with processed EEG monitoring. In this study, we propose to quantify the probable dose reduction of propofol with use of dexmedetomidine during CPA surgeries and compare the recovery profile, adequacy of cranial nerve monitoring, acid base status and intraoperative haemodynamics with and without the usage of dexmedetomidine.

 
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