| CTRI Number |
CTRI/2022/02/040200 [Registered on: 10/02/2022] Trial Registered Prospectively |
| Last Modified On: |
06/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess relation between hypotension and post operative delirium after anaesthesia in hip surgery |
|
Scientific Title of Study
|
Association of Intraoperative Hypotension with post operative delirium and cognitive dysfunction in elderly hip fracture patients in regional anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parul Jindal |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anesthesia
Himalayan Institute of Medical Sciences,Swami Rama Himalayan University
Dehradun
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9456547229 |
| Fax |
|
| Email |
parulpjindal@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruhi |
| Designation |
Postgraduate Resident |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anesthesia
Himalayan Institute of Medical Sciences,
Swami Rama Himalayan University
Dehradun
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9897888590 |
| Fax |
|
| Email |
ruhivaid1993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parul Jindal |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anesthesia
Himalayan Institute of Medical Sciences,Swami Rama Himalayan University
Dehradun
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9456547229 |
| Fax |
|
| Email |
parulpjindal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia Himalayan Institute of Medical Sciences,Swami Ram Nagar Jolleygrant Dehradun |
|
|
Primary Sponsor
|
| Name |
Himalayan Institute of Medical Sciences |
| Address |
Himalayan Institute of Medical Sciences,Swami Rama Himalayan University,Dehradun |
| 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 |
| DrParul Jindal |
Himalayan institute of Medical sciences |
Induction room pre op area Operation theatre 2nd floor Himalyan Institute Of Medical Sciences Swami Rama Himalyan University
Jolley grant
Dehradun
Dehradun
UTTARANCHAL |
9456547229
parulpjindal@yahoo.co.in |
|
|
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 |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA physical status I,II and III of either sex
2 Age more than 65 years.
3 Scheduled for hip surgery. |
|
| ExclusionCriteria |
| Details |
1.Patient less than 65 years of age.
2.Patient with ASA physical status IV.
2.patient with any spinal deformity
3.Patient with any Cognitive impairment
4.History of hypotension
5.Chronic use of Antipsychotic medications
6.BMI more than 30kg/m2
7.Failed Spinal anaesthesia
8.Patient refusal for regional anaesthesia
9.Any contraindications for Regional anaesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study effect of intraoperative hypotension on post operative delirium in elderly hip fracture patients. |
To study about delirium in elderly patients 24 hours post hip surgery done under regional anaesthesia with help of delirium scales |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine effect of any other factors on post operative cognitive outcomes. |
To determine association between preoperative comorbidities,functional status and nutritional status as risk factor of 24 hours post operative cognitive dysfunction |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/02/2022 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hip fracture are the commonest reason for elderly people to require emergency surgery ,hospital admission and account for increased orthopaedic trauma bed days than all other fractures.Hip fracture surgery presents various challenges to anesthetists and perioperative physicians.
As a result of advanced age,fraility and comorbidities of many people with hip fracture proceeding with anesthesia and surgery appears high risk.Hypotension occurs during hip fracture surgery .especially in case of older patients with comorbidities.
Elderly hip fracture patients are associated with significantly increased risk of cognitive dysfunction and post operative delirium.Delirium is a common problem in elderly patients and is associated with adverse outcomes,including longer length of hospital stay,decline in function and cognition .
Studies show that temporary brain perfusion of patients become impaired when patients experience prolong low blood pressure,can lead to cognitive impairment.Elderly hip fracture patients are associated with significantly increased risk of cognitive dysfunction and post operative delirium.
Delirium has a fluctuating course and is usually reversible.Development of cognitive dysfunction can be a key issue for increased morbidity and delayed functional recovery in early and late postoperative period.
The study is observational cohort study in which 70 patients are taken as sample size on the basis of previous studies.100% enumeration of cases will be done for duration of 12 months.
The goal of this study is to correlate hypotension in the intraoperative period in regional anesthesia in elderly patients undergoing hip fracture surgery and to assess post operative cognitive dysfunction and delirium in these patients. |