| CTRI Number |
CTRI/2023/02/050005 [Registered on: 23/02/2023] Trial Registered Prospectively |
| Last Modified On: |
14/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing different methods of monitoring pain, heart rate and blood pressure with opioid and non opioid medicines in patients undergoing the brain surgeries. |
|
Scientific Title of Study
|
Comparison of changes in Analgesia Nociceptive Index, Surgical Pleth Index, and
Hemodynamic parameters to noxious stimuli in patients receiving opioid and opioid free
analgesia undergoing supratentorial craniotomies – An open label comparative study. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAKESH T L |
| Designation |
SENIOR RESIDENT |
| Affiliation |
National Institute of Mental Health and Neurosciences, Bengaluru |
| Address |
FACULTY BUILDING, 3RD FLOOR, NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, BENGALURU
Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 5600029
Bangalore
KARNATAKA
560029
India |
| Phone |
9535751263 |
| Fax |
|
| Email |
rakeshtambi92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SONIA BANSAL |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
National Institute of Mental Health and Neurosciences, Bengaluru |
| Address |
FACULTY BUILDING, 4th FLOOR, NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, BENGALURU
Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 5600029
ph no - 080-26995000
Bangalore
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
itz.sonia77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SONIA BANSAL |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
National Institute of Mental Health and Neurosciences, Bengaluru |
| Address |
FACULTY BUILDING, 4th FLOOR, NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, BENGALURU
Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 5600029
ph no - 080-26995000
Bangalore
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
itz.sonia77@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES
Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka 560029 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES |
| Address |
Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RAKESH T L |
NATIONAL INSTITUTE MENTAL HEALTH AND NEUROSCIENCES |
Hosur Road, near Bangalore Milk Dairy, Bengaluru
Bangalore
KARNATAKA |
9535751263
rakeshtambi92@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D330||Benign neoplasm of brain, supratentorial, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj Dexemedetomidine |
-Group D – will receive inj dexmedetomidine at 1 mcg/kg iv over 10 min after
which the dose will be reduced to 0.5 mcg/kg/hr. |
| Comparator Agent |
Inj Fentanyl |
-Group F – will receive inj fentanyl at 2 mcg/kg iv over 10 min after which the dose will be
reduced to 1 mcg/kg/hr. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Patients aged between 18 and 65years of ASA I and II
-Patients undergoing elective supratentorial craniotomy |
|
| ExclusionCriteria |
| Details |
-Patients in whom dexmedetomidine is contraindicated (second and third degree heart block),
-Patients in whom ANI will be unreliable (patients with pacemakers, patients on drugs affecting
sinus node, patients having arrhythmias).
-Patients with liver and renal diseases.
-Patients on gabapentinoids, tricyclic antidepressants and other analgesics
-Patients posted for aneurysmal clipping
-Patients with decreased sensorium |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the magnitude of change and response time in ANI, SPI and hemodynamic parameters (HR and MAP) to various noxious stimuli between patients receiving OFA with dexmedetomidine and those receiving opioid analgesia with fentanyl for
supratentorial craniotomies.
(Response time is the time taken for the parameter to change maximally due to noxious
stimuli from the pre-stimuli value, i.e. lowest for the ANI and highest for SPI, HR and
BP)
(Magnitude of change is the difference between highest/lowest value after stimulation as compared to baseline i.e. pre-stimuli value) |
Before starting analgesic drug infusion and after 5 min and 10 min of starting infusion. At Intubation, skull pin insertion, skin incision, first burr hole placement, and durotomy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To compare the magnitude of change and response timein ANI, SPI, hemodynamics with in the group
-To determine and correlation between ANI and SPI in patients receiving opioid and OFA |
Before starting analgesic drug infusion and after 5 min and 10 min of starting infusion. At Intubation, skull pin insertion, skin incision, first burr hole placement, and durotomy. |
|
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Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/05/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
We hypothesize that while the performance of SPI(Surgical Pleth Index) may be similar with opioid and OFA (Opioid Free Analgesia), ANI(Analgesia Nociceptive Index) changes with noxious stimuli during surgery may be different (smaller magnitude of change with stimuli) due to the effect of dexmedetomidine on Heart Rate Variation. Dexmedetomidine has been shown to cause an increase in the HF (high frequency) component of power in ANI spectra. (Increase in HF component power indicates predominant parasympathetic surge). SPI has been effectively used as a guide to analgesia in patients receiving opioid and non opioid analgesia undergoing supratentorial craniotomies.10 Studies have established that ANI can detect painful stimuli in patients undergoing general surgeries under anaesthesia with opioid free analgesia. To the best our knowledge there are no studies assessing the performance of ANI in detecting nociception in patients receiving OFA in neurosurgical population. Hence, we intend to compare the changes in ANI, SPI and the hemodynamic parameters to nociception in patients receiving opioid and non opioid analgesia undergoing supratentorial craniotomies. |