| CTRI Number |
CTRI/2018/07/015125 [Registered on: 30/07/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Acutely disturbed state of mind(Delirium)after operation(Surgery)
|
|
Scientific Title of Study
|
Occurrence of postoperative delirium in patients undergoing elective surgeries under general anesthesia
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Javed Khan |
| Designation |
PG Anesthesiology |
| Affiliation |
LHMC DELHI |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, LHMC, SMT. S.K.HOSPITAL,
C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, 110001
Central DELHI 110001 India |
| Phone |
9013834635 |
| Fax |
|
| Email |
drjkhallim@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Usha Saha |
| Designation |
Director Professor Anesthesia |
| Affiliation |
LHMC DELHI |
| Address |
C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, Delhi 110001
Central DELHI 110001 India |
| Phone |
9810982588 |
| Fax |
|
| Email |
usha_shivsaha@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Usha Saha |
| Designation |
Director Professor Anesthesia |
| Affiliation |
LHMC DELHI |
| Address |
C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, Delhi 110001
Central DELHI 110001 India |
| Phone |
9810982588 |
| Fax |
|
| Email |
usha_shivsaha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANESTHESIOLOGY, LHMC, SMT. S.K.HOSPITAL,
C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, 110001 |
|
|
Primary Sponsor
|
| Name |
LHMC DELHI |
| Address |
C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, Delhi 110001 |
| 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 JAVED KHAN |
LHMC, SMT. S.K.HOSPITAL |
Department of Anesthesiology ,Main Operation Theatre, C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, Delhi 110001 Central DELHI |
9013834635
drjkhallim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee For Human Research, LHMC and Associated Hospitals New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All Patients planned for Elective Surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients 20-60 years of age, of either sex.
Elective surgeries under general anesthesia.
Elective surgeries under general anesthesia + Regional/Local anesthesia.
|
|
| ExclusionCriteria |
| Details |
Age < 20 and > 60 years
Emergency surgeries
Thoracic/Cardiac/Obstetric/Orthopedic/Neurosurgery
Sole Regional anesthesia/Local anesthesia
Patients requiring postoperative ventilatory support
Pre-existing neuropsychiatric disorder (seizures, Space occupying lesion(SOL), head injury)
Patients on antipsychotic drugs and drug or alcohol abuse.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of postoperative delirium in patients undergoing elective surgeries under general anesthesia.
|
Confusion Assessment Method (CAM) applied preoperatively , and postoperatively at 2 hours, days 1, 2 and 3. VAS score (0-100 scale) used to assess pain at all times of observation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Relationship between postoperative delirium and preoperative cognitive status.
2. Relationship between postoperative delirium and intraoperative factors (hemodynamic changes, blood transfusions, duration of anesthesia) and postoperative pain scores. |
Post operative Day3 follow up |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2016 |
| Date of Study Completion (India) |
01/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
"none yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Delirium is a common problem in hospitalized patients, with a
prevalence of 10-24% in medical population, 37–46% in surgical population, and
upto 87% in ICU patients. In individuals over 65 years of age,
hospitalized for medical conditions, approximately 10% exhibit delirium on
admission, and another 10-15% may develop delirium while in hospital (DSM IV
1994).In Indian population, Rudraetal(2006)recorded 15% incidence of
delirium in elderly patients after major elective surgeries.
Delirium is an acute and fluctuating disturbance of
consciousness with reduced ability to focus, maintain, or shift attention,
accompanied by change in cognition and perceptual disturbances, along with psychomotor, emotional and sleep-wake
cycle disturbances.
Delirium is not a disease, but is a symptom of many
pathological conditions, such as increasing age, dementia, infections,
tumors, chronic diseases, metabolic disorders, fever, and intoxication. Post-operative delirium(POD) manifests in patients who have
undergone surgical procedures and anesthesia, usually peaking within three
days. Most recover within 4 weeks, but in 50% cases it may persist
longer. Incidence of POD varies with patients
age, pain scores, type of surgery, degree of operative stress, low
pre-operative executive scores and depression. POD is a serious complication, associated with increased
hospital and ICU length of stay, functional decline, high medical cost, 10 fold
increased risk of dementia, post-discharge institutionalization and
death. Mortality increases by 10–20% for every 48 hours of
delirium, chiefly from association with other postoperative complications. In
literature, most studies are in elderly patients and very few in the young
adult population. Hence, we decided to carry out this study for occurrence of
POD in patients 20-60 years age, and identify risk factors that may help in
early diagnosis of Delirium and avoidance of POD. |