| CTRI Number |
CTRI/2019/05/019276 [Registered on: 23/05/2019] Trial Registered Prospectively |
| Last Modified On: |
20/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of propofol and isoflurane-based general anaesthesia on cognitive skills of elderly patients |
|
Scientific Title of Study
|
Comparative Evaluation of Postoperative Cognitive Dysfunction following General Anaesthesia with Propofol and Isoflurane in Elderly Patients |
| Trial Acronym |
POCD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neetha Prabhu |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology
BL Taneja Block
Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
09739236370 |
| Fax |
|
| Email |
neethaprabhu93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Rani Sharma |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology
BL Taneja Block
Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604376 |
| Fax |
|
| Email |
drkavitadn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neetha Prabhu |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology
BL Taneja Block
Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi
New Delhi
DELHI
576102
India |
| Phone |
09739236370 |
| Fax |
|
| Email |
neethaprabhu93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital
Bahadur Shah Zafar Marg
New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi-110002 |
| 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 Neetha Prabhu |
Lok Nayak Hospital |
Department of Anaesthesiology and critical care
3rd floor, BL Taneja Block
Lok Nayak Hospital and associated Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi- 110002
New Delhi
DELHI |
09739236370
neethaprabhu93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients posted for elective surgeries under general anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cognitive assessment preoperatively and 24 hours postoperatively |
Cognitive assessment will be done using Hindi Mental State examination, Digit span test and Digit symbol substitution test preoperatively and 24 hours postoperatively |
| Intervention |
Maintenance of anaesthesia with intravenous infusion of propofol(Group P) |
After a detailed pre-anaesthetic evaluation, including preoperative cognitive assessment, general anaesthesia will be induced with Inj Propofol 1.5-2mg/kg and maintained with Inj Propofol infusion at the rate of 50-150mcg/kg/min |
| Intervention |
Maintenance of anaesthesia with isoflurane at MAC of 1.0-1.5(Group I) |
After detailed pre-anaesthetic evaluation including preoperative cognitive assessment, general anaesthesia will be induced with Inj Propofol 1.5-2mg/kg and maintained with Isoflurane at MAC of 1.0-1.5 in 50% oxygen in nitrous oxide |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of American Society of Anaesthesiologists (ASA) physical status grades I/II/II requiring surgeries with expected duration of anaesthesia > 2hours |
|
| ExclusionCriteria |
| Details |
Patients unable to comprehend the required cognitive assessment tests
Hindi Mental State Examination score less than or equal to 26 preoperatively
Known cases of any psychiatric illness
History of cerebrovascular accident
Known disorder affecting cognition
Known history of alcohol or drug abuse
Deranged kidney function tests
|
|
|
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 |
| Incidence of Postoperative Cognitive Dysfunction as assessed by Hindi Mental State Examination, Digit Span test and Digit Symbol Substitution Test, when there is at least 20% change from baseline values in at least 2 of these tests. |
24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients showing at least 20% change from baseline values in individual assessment tests |
24 hours postoperatively |
| Sensitivity of the three tests in detecting POCD |
24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
24/05/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Postoperative Cognitive Dysfunction is a well-recognized clinical phenomenon and the incidence is much higher in elderly patients. There are conflicting reports on the incidence of postoperative cognitive dysfunction following the use of inhalational and intravenous anaesthetic agents. We will be doing a comparative evaluation of the incidence of Postoperative cognitive dysfunction following general anaesthesia with propofol and isoflurane in elderly patients. Patients aged 60-80 years requiring general anaesthesia would be evaluated. Those fulfilling inclusion/exclusion criteria will be recruited. Baseline evaluation using Hindi Mental State Examination, Digit Span test and Digit symbol substitution test will be done. Following which the enrolled patients will be randomized into the two intervention arms. The subjects of both groups will be taken into the operation theatre, standard monitors, including bispectral index(BIS) attached, Inj Fentanyl 2mcg/kg will be administered and baseline vitals will be recorded. Induction will be done with Inj Propofol 1.5-2mg/kg in titrated doses till loss of verbal response. Inj Vecuronium 0.1mg/kg will be used to achieve neuromuscular blockade and airway will be secured with an appropriate sized endotracheal tube when BIS decreases to 40-60. In patients of group P, anaesthesia will be maintained with IV infusion of propofol at the rate of 50-150mcg/kg/min and controlled ventilation provided using 50% oxygen in nitrous oxide. In patients of group I anaesthesia will be maintained with 50% oxygen in nitrous oxide and isoflurane at MAC 1.0-1.5. Muscle relaxation will be maintained with Inj Vecuronium top up of 0.02mg/kg. Depth of anaesthesia will be monitored by BIS and propofol and isoflurane concentrations will be titrated to maintain BIS in the range of 40-60. After ensuring isovolumia, if there is an increase in heart rate and systolic blood pressure of >20% from baseline, Inj Fentanyl 0.25mcg/kg IV top-up will be administered. Local anaesthetic infiltration at the surgical incision site will be given at the end of the surgery. Anaesthetics will be stopped at the end of the surgery and neuromuscular blockade will be antagonized with neostigmine 0.05mg/kg and glycopyrrolate 0.01mg/kg. Patients will be extubated after they recover spontaneous breathing and BIS increases to >80. Postoperative cognitive dysfunction will be assessed 24 hours postoperatively by means of the above mentioned tests. Statistical analysis will be done using Mann Whitney-U test for quantitative data and Chi-square test or Fisher’s exact test to find association between these 2 groups. |