| CTRI Number |
CTRI/2024/08/072722 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
18/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of dexmedetomidine and ketamine |
|
Scientific Title of Study
|
Effect of dexmedetomidine and ketamine on bispectral index during induction with propofol: A randomised double blinded controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivedita patil |
| Designation |
Postgraduate in MD anaesthesiology |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Room no 206,second floor,department of anaesthesiology
Karnataka institute of medical sciences, PB road ,Vidyanagar
Hubballi
Dharwad
KARNATAKA
580022
India |
| Phone |
7619239780 |
| Fax |
|
| Email |
niveditapatil37527@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Professor and head |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Room no 206,second floor,department of anaesthesiology
Karnataka institute of medical sciences, PB road ,Vidyanagar
Hubballi
Dharwad
KARNATAKA
580022
India |
| Phone |
9449590556 |
| Fax |
|
| Email |
drmadhuri_kurdi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Professor and head |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Room no 206,second floor,department of anaesthesiology
Karnataka institute of medical sciences, PB road ,Vidyanagar
Hubballi
Dharwad
KARNATAKA
580022
India |
| Phone |
9449590556 |
| Fax |
|
| Email |
drmadhuri_kurdi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Karnataka institute of medical sciences,PB road, Vidyanagar,Hubballi ,dharwad, karnataka- 580022, India |
|
|
Primary Sponsor
|
| Name |
Karnataka institute of medical sciences |
| Address |
Department of anaesthesiology,
Karnataka institute of medical sciences,PB road, Vidyanagar,Hubballi ,dharwad, karnataka- 580022, India |
| Type of Sponsor |
Government medical college |
|
|
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 Nivedita patil |
Karnataka institute of medical sciences |
Room no 206,department of anaesthesiology,
Karnataka institute of medical sciences
Hubballi-580022
Dharwad
Karnataka
Dharwad
KARNATAKA |
7619239780
niveditapatil37527@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences, Hubballi Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV dexmedetomidine |
Patient will receive IV dexmedetomidine, 1mcg per kg in 100ml NS over 10mins after induction with propofol and intubation.Duration of intervention will be for 10 minutes |
| Comparator Agent |
IV ketamine |
Patient will receive IV ketamine 1mg per kg in 100ml NS over 10mins after induction with propofol and intubation.
Duration if comparator agent will be for 10 minutes. |
| Comparator Agent |
Normal saline |
Patient will receive 100ml normal saline over 10mins after induction with propofol and intubation.Duration of comparator agent will be for 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient belonging to ASA 1 and 2 physical status giving informed valid written consent ,undergoing elective gastro/onco/ENT surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient with known Cardiac, renal, neurological,psychiatric disorders,Obesity with BMI more than 30kg per metersquare,pregnant females, drug and alcohol abuse,on chronic medications such as anticonvulsant and antidepressants |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Depth of anaesthesia interested of BIS values in 3 groups that is propofol, propofol- dexmedetomidine, propofol- ketamine and to find out how addition of dexmedetomidine and ketamine to propofol can affect BIS |
- Preinduction
-Soon after intubation
-Every 5 minutes after starting study drug infusion till the end of study period that is 10 minutes
-5 minutes after completion of study drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess hemodynamic and EtCO2 level changes with dexmedetomidine and ketamine addition to propofol |
With each reading of BIS value |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bispectral index (BIS) is a widely used electroencephalography (EEG) based quantitative parameter utilised for monitoring the depth of anaesthesia. BIS combines the information from 3 analyses : the spectrogram, the bispectrum, time domain assessment of burst suppression. It is recorded from a 4 lead frontal montage.The value of BIS ranges from 0-100 and indicates the patient’s anaesthetic state. Recommended BIS values during general anaesthesia range between 40-60.
Hypnotic drugs used in anaesthesia produce sleep by different mechanisms and hence produce variable effects on the EEG. The effect of several hypnotic drugs such as ketamine on the BIS values and EEG is still not clear.This becomes a limitation of the BIS monitor. The degree of effect of individual drugs and agents such as dexmedetomidine , propofol , isoflurane and sevoflurane on the BIS value and its correlation with the degree of sedation has also been food for several researchers.
Ketamine is an intravenous dissociative anaesthetic with analgesic properties in subanaesthetic doses. It is a non-competitive antagonist of N-methyl-D-aspartic acid (NMDA) receptor that participants in excitatory neuro transmission in the central nervous system. Some studies have shown that ketamine increases the BIS value,whereas others have shown that ketamine does not increase the BIS values.
Dexmedetomidine is an alpha-2 receptor agonist ,widely used in anaesthesia for its sympatholytic , sedative and analgesic effects . It acts on the locus coeruleus , produces physiological sleep like phenomena in the EEG and characteristic arousable sedation,which is markedly different from that of other sedatives such as gamma aminobutyric acid agonists (eg-propofol). Studies have shown that dexmedetomidine increases the BIS values produced by induction doses of propofol and BIS has been used as a monitoring parameter to assess and compare the level of sedation and hypnosis in several studies wherein these drugs have been administered.The relationship between BIS and dexmedetomidine administration/ ketamine administration has been studied individually by researchers.
However, there is scarce literature available on the combined effect of dexmedetomidine-propofol and ketamine-propofol on the BIS value. These drug combinations are nowadays commonly employed in anaesthetic practice. Hence, this study is planned to study the effect of these drug combinations on bispectral index values.
Aim of the study
To study the combined effect of dexmedetomidine-propofol and ketamine-propofol on the BIS value.
Objectives -
Primary Aim : To compare BIS values with propofol, propofol-dexmedetomidine, propofol -ketamine and to find out how addition of dexmedetomidine /ketamine to propofol can affect BIS.
Secondary Aim: To assess hemodynamic and EtCO2 level changes with dexemedetomidine /ketamine addition to propofol.
Materials and methods- Prospective randomised double blinded controlled trial.
Sample size- 28 patients in each group
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