| CTRI Number |
CTRI/2024/07/071553 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the incidence of post operative delirium with dexmedetomidine and fentanyl in postoperative cardiac patients 12th hourly for 7 days in ICU. |
|
Scientific Title of Study
|
Incidence of Delirium with Dexmedetomidine compared with fentanyl based therapy in post operative cardiac surgical patients:A Randomized controlled single blinded 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 |
Pavani paidi |
| Designation |
Post graduate student |
| Affiliation |
Institue of medical science and sum hospital. |
| Address |
Department of Anesthesiology,IMS & SUM hospital,Siksha O Anusandham University,Bhubaneswar,Khorda.
Khordha
ORISSA
751003
India |
| Phone |
7993371341 |
| Fax |
|
| Email |
paidipavani243@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ranjita acharya |
| Designation |
Professor |
| Affiliation |
Institue of medical science and sum hospital. |
| Address |
Department of Anesthesiology,IMS & SUM hospital,Siksha O Anusandham University,Bhubaneswar,Khorda.
Khordha
ORISSA
751003
India |
| Phone |
8763421899 |
| Fax |
|
| Email |
drranjitaacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavani paidi |
| Designation |
Post graduate student |
| Affiliation |
Institue of medical science and sum hospital. |
| Address |
Department of Anesthesiology,IMS & SUM hospital,Siksha O Anusandham University,Bhubaneswar,Khorda.
Khordha
ORISSA
751003
India |
| Phone |
7993371341 |
| Fax |
|
| Email |
paidipavani243@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS & SUM hospital,Siksha O Anusandham University,Bhubaneswar,Khorda. |
|
|
Primary Sponsor
|
| Name |
Institue of medical science and sum hospital |
| Address |
K8,Kalinganagar,Bhubaneswar,Odisha,
751003. |
| Type of Sponsor |
Private 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 Pavani paidi |
Institute of medical sciences,siksha O Anusandhan |
Department of Anaesthesia,CTVS o.t,k8 kalinga nagar,Bhubaneswar,odisha,751003
Khordha
ORISSA |
7993371341
paidipavani243@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,IMS & SUM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: I20-I25||Ischemic heart diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
Fentanyl 1mcg/kg/hr intravenously infusion given continuously to the one set of patients till next day morning 6 am after shifting the patients to ICU and Degree of delirium is assessed 12,24,36,48,60,72,84,96,108,
120,132,144,156,168 hours and infusion will be stopped on next day morning 6am,the period from the start of fentanyl infusion to its termination the next morning 6 am was the overall ammount given. |
| Intervention |
Dexmedetomidine |
Dexmedetomidine 0.5 mcg/kg/hr intravenously infusion given continuously to the one set of patients till next day morning 6 am after shifting the patients to ICU and Degree of delirium is assessed 12,24,36,48,60,72,84,96,108,
120,132,144,156,168 hours and infusion will be stopped on next day morning 6am,the period from the start of Dexmedetomidine infusion to its termination the next morning 6 am was the overall ammount given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age group 18-80 years scheduled for on pump cardiac surgeries. |
|
| ExclusionCriteria |
| Details |
1.Patients not giving consent
2.Patients with severe congestive heart failure,(ejection fraction less than 40),second degree heart blocks,neurological disorders,renal and liver failures.
3.If patient is hypotensive preoperatively.
4.If patient baseline heart rate is less than 55per min.
5.If patient has pacemaker insitu.
6.Patient getting reoperated.
7.Patient hypersensitive to opioids and known drug allergies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of postopertive delirium(confusion assessment method)with dexmedetomidine and fentanyl |
12th hourly for 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of sedation and analgesia,trail of extubation done after 12 hours of shifting the patient to ICU, ,incidence of tachyarrythmias,haemodynamic parameters(HR,MAP,SPO2) and side effects like nausea and vomitings |
2,,6,12,24,48 hourly-sedation and analgesia |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 4 |
|
Date of First Enrollment (India)
|
06/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
This is a prospective randomised single blinded comparative study conducted at our institution in CTVS operation theatre and ICU
•The
data to be collected are all part of routine care.
•All the Data collected will be
entered in Microsoft excel 2007 and further analysed in SPSS
VERSION-27.Categorised variables will be expressed in numericals
and percentage.Continuous
variable will be expressed by CHI-SQUARE/FISCHER EXCAT TEST.Comparision
between two means will be assessed using T test/Mann whitney.
•P value <0.05 will be constant
• SAMPLE
SIZE
•Assumption
:150
•Method
Used:Based
on previous study of yahya shehabi,the
incidence of delirium in F group is 28%.To detect clinically relevant 50%
reduction in delirium in DEXMEDETOMIDINE group with alpha value of 0.05 power
of 80% and with 1:1 Randomization the sample size was calculated to be 150(75 in
each group).The sample size was calculated in spss version 27 after considering no
drop out.
•Initial
estimate :150
•Corrected
estimate :150In this study 150 cardiac
patients between age 18 years to 80 years posted
for elective on pump cardiac surgery were included
After taking
written informed consent from parents/guardians, patients will be randomized to
2 groups (n= 75 each ) by computer
generated random number table. All patients will be thoroughly examined pre-operatively which includes blood
pressure, heart rate, respiratory rate and systemic examination, and ASA grading. The patients with a
contraindication to procedure like allergic reaction to opioids or major neurological, cardiovascular, metabolic, respiratory, renal disease, or coagulation abnormalities and liver dysfunction will be excluded.
The confusion assessment method
scale for delirium severity will be explained to all the patients.
The
sedation is assessed by Richmond Agitation and sedation scale and it has a
scale from -4 to +5 together with
pain scale critical-care pain observation toll(CPOT) and Wong-Baker Faces Pain
will be explained to all the patients.
CAM-SCALE
consists of 4 items with 0-2 grades, they are Acute onset or fluctuation of
mental status,Inattention,Altered level of consciousness and Disorganized thinking.
|