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
|
|
Primary Sponsor
|
Name |
None |
Address |
None |
Type of Sponsor |
Other [None] |
|
Details of Secondary Sponsor
|
|
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
|
|
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. |