| CTRI Number |
CTRI/2024/02/062471 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Bispectral Index Value in Elderly Population under Spinal Anaesthesia |
|
Scientific Title of Study
|
The Comparison of Bispectral Index Value Under Spinal Anaesthesia in Elderly Patients with Bupivacaine versus Bupivacaine and Fentanyl |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanna vadhanan |
| Designation |
Professor and HOD |
| Affiliation |
vinayaka Mission Research Foundation |
| Address |
Department of anaesthesiology Vinayaka missions medical college Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
|
| Fax |
|
| Email |
vadhanan@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeniffer karan |
| Designation |
Post graduate |
| Affiliation |
Vinayaka mission medical college |
| Address |
Department of anaesthesiology Vinayaka missions medical college Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
8056945708 |
| Fax |
|
| Email |
jenny.pyr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jeniffer karan |
| Designation |
Post graduate |
| Affiliation |
vinayaka Mission Research Foundation |
| Address |
Department of anaesthesiology Vinayaka missions medical college Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
8056945708 |
| Fax |
|
| Email |
jenny.pyr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology Vinayaka missions medical college Karaikal |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Research Foundation |
| Address |
NH47 Sankari Main Road Salem Tamilnadu 636308 |
| 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 |
| Dr Prasanna Vadhanan |
Vinayaka Missions Medical College And Hospital |
Department of Anaesthesiology First floor OT complex Vinayaka Missions Medical College and Hospital Keezhakasakudi Medu Kottucherry post
Karaikal
PONDICHERRY |
609609
vadhanan@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K605||Anorectal fistula, (2) ICD-10 Condition: K412||Bilateral femoral hernia, withoutobstruction or gangrene, (3) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (4) ICD-10 Condition: K601||Chronic anal fissure, (5) ICD-10 Condition: K643||Fourth degree hemorrhoids, (6) ICD-10 Condition: S723||Fracture of shaft of femur, (7) ICD-10 Condition: S822||Fracture of shaft of tibia, (8) ICD-10 Condition: K642||Third degree hemorrhoids, (9) ICD-10 Condition: K419||Unilateral femoral hernia, withoutobstruction or gangrene, (10) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (11) ICD-10 Condition: K649||Unspecified hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
injection Bupivacaine 0.5% heavy 2.5ml given intrathecal route measuring bispectral index values for frist one hour |
| Comparator Agent |
Bupivacaine and Fentanyl |
injection Bupivacaine 0.5% heavy 2.5ml with injection fentanyl 0.2ml given intrathecal route measuring bispectral index values for frist one hour |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Both Male and Female Patients
2.above 65 years to 99 year old
3.undergoing elective surgeries under spinal anaesthesia
4.under ASA 1 2 and 3 |
|
| ExclusionCriteria |
| Details |
1.under ASA 4 and 5
2.uncontrolled systemic disorder
3.neurological impairment
4. demyelinating disease
5.patient refusal |
|
|
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 |
| Bispectral index values |
Bispectral index values every 5 minutes for first hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Level of spinal anaesthesia |
for first hour |
| Haemodynamic stability |
1st hour |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/02/2024 |
| 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
|
Bispectral index is a continuous form of non invasive complex processed electroencephalogram derived parameter which has been validated as a quantifiable objective measure of sedative hypnotic effects of drugs by taking elder population as sample to measure the depth of the anaesthesia to the drug given intrathecally such as injection bupivacaine 0.5% 2.5ml as separate group along with that injection fentanyl 0.2 ml as separate group where these elderly population itself a physiologically compromised condition need greater modification in dosage ,this study helps in identification of higher segmental block and its impact in hemodynamic effects in elderly population |