| CTRI Number |
CTRI/2025/07/090706 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Blood Pressure and Heart Rate in fragile and non fragile elderly patients undergoing hip surgery |
|
Scientific Title of Study
|
Study of perioperative hemodynamic parameters in elderly patients undergoing hip surgery under spinal anesthesia: Comparison between frail and non-frail groups |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manish kumar |
| Designation |
PostgraduateTrainee |
| Affiliation |
Midnapore Medical College |
| Address |
Department of Anesthesiology , MIDNIPORE MEDICAL COLLEGE ,VIDYASAGAR ROAD , PS-kotwali PASCHIM MIDNAPORE
Medinipur
WEST BENGAL
721101
India |
| Phone |
7677753223 |
| Fax |
|
| Email |
Manishkumarmgm12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Debasish Bhar |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Anesthesiology, Midnapore Medical college, VIDYASAGAR ROAD ,Ps-kotwali PASCHIM MIDNAPORE
Medinipur
WEST BENGAL
721101
India |
| Phone |
8617753967 |
| Fax |
|
| Email |
debasish77bhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEBASISH BHAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
|
| Address |
DOCTOR QUARTER, MIDNAPORE MEDICAL COLLEGE CAMPUS, VIDYASAGAR ROAD , PASCHIM MIDNAPORE
Medinipur
WEST BENGAL
721101
India |
| Phone |
8617753967 |
| Fax |
|
| Email |
debasish77bhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Midnapore Medical College And Hospital, Vidya Sagar Road ,PS- kotwali, west bengal pin -721101 |
|
|
Primary Sponsor
|
| Name |
Goverment Of West Bengal |
| Address |
Government Of West Bengal, Department Of Health And Family Welfare |
| 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 Debasish Bhar |
orthopedic operation theatre, Bidhan Block , Room no 3 |
Midnapore medical college , Vidyanagar road ,PS-kotwali Paschim Midnapore, pin -721101
Medinipur
WEST BENGAL |
8617753967
debasish77bhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Midnapore Medical College, Paschim Medinipur pin-721101, ph- 03222274321 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patient with unilateral hip fracture
ASA I II III
Scheduled for spinal anesthesia
Mentally fit to give written informed consent |
|
| ExclusionCriteria |
| Details |
NEWS more than 5
Severely frail patient
Surgical time more than 2 hours
Patient planned for total hip replacement
Patient having pelvic bone or acetabular fracture
Contraindications of spinal anesthesia
Conversion to general anesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare hemodynamic changes ( mean arterial pressure ,heart rate ,and ST changes) between frail and non frail groups undergoing hip surgery under spinal anaesthesia |
To compare mean arterial pressure ,heart rate ,and ST changes between frail and non frail groups every 3 min for first 30 min. Thereafter at 5 min interval till the end of the surgery.
Post operatively vitals will be recorded at 30 min interval for 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare height & duration of sensory & motor block
To compare the incidence of complication if any
|
6 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2025 |
| 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
|
Frailty is defined as a state of vulnerability due to reduced physiological reserve that predisposes the patients to adverse outcomes from different types of stress including surgery. Frailty is measured by frailty index (FI). The principle of this index is to count the deficits in health (which can be symptoms, signs, diseases, disabilities or laboratory, radiographic or electrocardiographic abnormalities). The index is expressed as a ratio of deficits present to the total number of deficits considered. FI<0.12 is considered non frail, 0.12-0.24 is considered mild frail, 0.24- 0.36 is moderate frail and index more than 0.36 is regarded as severely frail. Intra-operative complication that occurs most commonly in the frail patients includes hypotension that requires vasopressor or blood transfusion. Evidence on intraoperative hemodynamic instability in frail patients is particularly limited. After approval of CTRI, all elderly patients (age>65-85 years) planed for unilateral hip surgery under spinal anesthesia over the next one year will undergo pre anesthetic check up by history taking, clinical examinations and investigations. National Early Warning Score (NEWS) will be assessed in each patient depending on the clinical examination. Patients having score <5 will be assessed for eligibility. Frailty index (FI) will be calculated based on the deficits (Table 2). Depending on the FI value, patients will be allocated in three groups after written informed consent; Group NF (Non-frail), group MiF (mild frail) and group MoF (moderate frail). In all patient subarachnoid block will be performed at L3-4 or L4-5 inter space in sitting position with 0.5% hyperbaric bupivacaine (1.5 ml) and fentanyl 25 mcg. Intraoperative MAP, HR and ST changes will be compared at every 3 min interval for 30 min, thereafter at 5 min interval till the end of surgery. Post operatively vitals will be recorded at 30 min interval for 6 hours. Incidence of hypotension, bradycardia or other complications will be recorded. As there is no previous study comparing hemodynamic changes in different types of frail patients, outcome will be evident only after the completion of the study. |