| CTRI Number |
CTRI/2023/08/056581 [Registered on: 17/08/2023] Trial Registered Prospectively |
| Last Modified On: |
16/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the difference between General Anaesthesia and Regional Anaesthesia (spinal and epidural anaesthesia) in patients above the age of 65 years or above undergoing hip replacement surgery |
|
Scientific Title of Study
|
A comparative analysis of
peri-operative complications and outcomes between General and Regional Anaesthesia in elderly patients undergoing hip arthroplasty |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aanchal Mehta |
| Designation |
DNB resident Anaesthesiology |
| Affiliation |
Max Super Speciality Hospital, Mohali |
| Address |
Department of Anaesthesia and Pain Management, Max Super Speciality Hospital, Mohali, Punjab
Chandigarh
CHANDIGARH
160056
India |
| Phone |
7888452247 |
| Fax |
|
| Email |
aanchalmehta95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Y K Batra |
| Designation |
Senior Director- Anaesthesia and Pain Management |
| Affiliation |
Max Super Speciality Hospital, Mohali |
| Address |
Department of Anaesthesia and Pain Management, Max Super Speciality Hospital, Mohali, Punjab
Chandigarh
CHANDIGARH
160056
India |
| Phone |
9646624870 |
| Fax |
|
| Email |
ykbatrapgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Y K Batra |
| Designation |
Senior Director- Anaesthesia and Pain Management |
| Affiliation |
Max Super Speciality Hospital, Mohali |
| Address |
Department of Anaesthesia and Pain Management, Max Super Speciality Hospital, Mohali, Punjab
Chandigarh
CHANDIGARH
160056
India |
| Phone |
9646624870 |
| Fax |
|
| Email |
ykbatrapgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital, Mohali, Punjab |
|
|
Primary Sponsor
|
| Name |
Max Super Speciality Hospital Mohali |
| Address |
Department of Anaesthesia and Pain Management, Max Super Speciality Hospital, Mohali, Punjab |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Y K Batra |
Max Super Speciality Hospital |
Department of Anaesthesia and Pain Management, Max Super Speciality Hospital, Mohali, Punjab
Chandigarh
CHANDIGARH |
9646624870
ykbatrapgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Max Super Speciality Hospital, Mohali |
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 |
| Comparator Agent |
Nil |
Nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anesthesiologists (ASA) I-III of either sex.
2. Patients aged more than or equal to 65 years.
|
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal to be included in the study
2. Patients undergoing revision hip arthroplasty.
3. Patients with active covid infection.
4. Patients with active respiratory or urinary tract infection.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To elicit the major peri operative complications & comparing the incidence of various adverse outcomes between regional & general anaesthesia for hip arthroplasty |
For first 48 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the differences in 7 & 30-day mortality |
Post operative day 7 & 30 |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
30/08/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective, consecutive, non- randomised, non blinded, observational study that will be organised and carried out in the Department of Anaesthesia and Pain Management, Max Super Speciality Hospital, Mohali, Punjab with due authorisation from the Institutional Ethics Committee and Review Board and in compliance to informed, written consents taken from patients. This study is to evaluate and compare peri-operative complications and outcomes between general and regional anaesthesia in elderly patients undergoing hip arthroplasty. |