| CTRI Number |
CTRI/2021/03/032265 [Registered on: 24/03/2021] Trial Registered Prospectively |
| Last Modified On: |
29/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing anaesthesia given through veins and anaesthesia given through lungs for post operative confusion and memory loss |
|
Scientific Title of Study
|
Comparison of Total intravenous anaesthesia Vs Inhalational maintenance of anaesthesia for early post operative delirium in adult cardiac
surgery :Prospective randomized double blinded study. |
| Trial Acronym |
TIVA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varsha A V |
| Designation |
Senior Resident |
| Affiliation |
SCTIMST |
| Address |
Department of cardiothoracic and vascular anaesthesia
SCTIMST
Thiruvananthapuram
KERALA
695011
India |
| Phone |
08220639596 |
| Fax |
|
| Email |
drvarshaav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Unnikrishnan KP |
| Designation |
Professor |
| Affiliation |
SCTIMST |
| Address |
Department of cardiothoracic and vascular anaesthesia
SCTIMST
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446177521 |
| Fax |
|
| Email |
unnikp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varsha A V |
| Designation |
Senior Resident |
| Affiliation |
SCTIMST |
| Address |
Department of cardiothoracic and vascular anaesthesia
SCTIMST
Thiruvananthapuram
KERALA
695011
India |
| Phone |
08220639596 |
| Fax |
|
| Email |
drvarshaav@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SCTIMST fluid research grant |
| Address |
Sreechitra institute of medical science and technology |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Unnikrishnan KP |
Sree Chithira Thirunal Institute of Medical science and technology |
Department of cardiothoracic and vascular anaesthesia
SCTIMST
Trivandrum
Thiruvananthapuram
KERALA |
9446177521
unnikp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,SCTIMST |
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 |
Propofol |
Propofol infusion will be used at dose of 4 to 6 ml/kg to maintain anaesthesia through out the cardiopulmonary bypass period in the TIVA group titrated to BIS of less than 60. It is administered continuously during the entire cardiopulmonary bypass period. |
| Comparator Agent |
Sevoflurane |
Use of sevoflurane at 1.6 to 2% via vaporizer mounted on the bypass machine in inhalational group for maintenance of anaesthesia during entire period of cardiopulmonary bypass titrated to BIS less than 60.there is no specific time point of administration.it is continuously administered during the entire cardiopulmonary bypass period using a vaporizer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1.Age from 18 -80 yrs
2.Undergoing CABG or Aortic valve surgery for Aortic stenosis on CPB
3.Consenting for the study |
|
| ExclusionCriteria |
| Details |
emegency surgery, poor language comprehension, neurologic disorders, allergy to anaesthetic agent,significant carotid artery stenosis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Compare the incidence of early postoperative delirium on post opeative day 1 and 2 in both the groups
2.Compare the cerebral oxygen saturation in both the groups |
1.Compare the incidence of early postoperative delirium in both the groups on post operative days 1 and 2
2.Compare the cerebral oxygen saturation in both the groups baseline before induction,after intubation induction,immediately after
going on cardiopulmonary bypass,after aortic cross clamp,at moderate hypothermia(28°c),during rewarming,after cpb and after sternal closure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intraoperative glycaemic control in both the groups
2.Analyse the Katz 3-5 atherosclerosis in the patients with post op delirium.
3.Analyse incidence of early post-operative cognitive dysfunction in both the groups |
1.Blood glucose baseline at start of case,after going on cpb and immideately after coming off CPB
2.Preoperative TEE KATZ score done after intubation
3.MOCA score for post operative cognitive dysfunction assessment day before surgery and on post operative day 7 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/03/2021 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It
will be a prospective randomized double blinded interventional study. After
approval from the IEC and getting informed consent 80 consecutive patients
undergoing CABG or Aortic valve replacement for Aortic stenosis will be
randomly allocated to receive either inhalation anaesthesia or Total
intravenous anaesthesia. Computer generated random table will be used to
allocate subjects to one of the study groups. Sequentially numbered sealed
opaque envelopes will contain the treatment code, to be opened in the morning
of surgery. Patients and the principal investigator will be unaware of group
assignment. All the statistical analyses will be performed by the
biostatistician not involved in treatment allocation.
Standard anaesthesia
induction and intubation will be done using fentanyl 5-10 mcg/kg, midazolam
0.05-0.1 mg/kg, propofol sleep dose upto 2mg/kg and pancuronium 0.1mg/kg.Fentanyl
infusion will be started at 2mcg/kg/hr. Total upto 20 mcg/kg fentanyl will be
given prior to sternotomy. Baseline demographics of all the patients including
age, sex, height,weight, BMI
,comorbidities and type of surgery will be noted .Baseline Montreal cognitive
assessment score will be assessed the day before surgery. All standard ASA
monitoring will be done. Additionally Bispectral index monitoring will be done
to ensure adequate depth of anaesthesia and maintained at < 60. Near-infrared
spectroscopy to record cerebral oximetry and TEE for regular cardiac evaluation
and to look for atheroma and its grade will be used. Patients in the Total intravenous anaesthesia group
will receive propofol titrated to Bispectral index for maintenance along with
fentanyl infusion during cardiopulmonary bypass while the patients in the Inhalational group will receive
sevoflurane titrated to Bispectral index along with fentanyl infusion for
maintenance on CPB. The depth of
anaesthesia will be monitored and
maintained in both the groups using
Bispectral index monitor. All patients will be
screened for presence of atheromatous plaque in the aorta and the Katz grading will be noted.. The MAP will be maintained above 60mm Hg till institution
of CPB .PaCO2 will be maintained at 35-45 mmHg. CPB will be instituted and maintained as per
standard protocol. NIRS values will be recorded
at various time intervals: baseline,
intubation, after going on CPB,
after cross-clamping, at lowest temperature, during warming at 36°C,
post-bypass and after skin closure. MAP on CPB will be maintained more than 50 mmHg and
the haematocrit more than 21%.Other parameters recorded will be
duration of CPB, cross clamp time and intraoperative glucose levels. In the ICU
time to extubation readiness will be noted. Dexmedetomidine infusion for
sedation at 0.1 -0.3 mcg/kg /hr will be started for all patients on arrival to
the ICU and continued for 24 hrs with fentanyl infusion at 1mcg/kg/hr. All
patients will receive 6th hourly IV paracetamol for post-operative
analgesia. Postoperative delirium(time frame: 2 days after surgery) detection
will be managed with Confusion Assessment Method for the ICU (CAM-ICU) on POD1
and 2.Delerium will be managed with quetiapine or haloperidol as per
intensivist order. Early postoperative cognitive dysfunction (Time Frame: 7
days after surgery )we will use Montreal Cognitive Assessment (MoCA) to detect
cognitive dysfunction |