| CTRI Number |
CTRI/2024/03/063739 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of granisetron and nor-epinephrine to prevent hypotension after spinal anaesthesia in old patients. |
|
Scientific Title of Study
|
Comparison of prophylactic administration of Granisetron versus Norepinephrine for Spinal Anaesthesia induced Hypotension in elderly population: A Prospective Randomized Study †|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arvind Singh Bissarwal |
| Designation |
Junior resident |
| Affiliation |
Teerthanker Mahaveer medical college and research centre, Moradabad |
| Address |
Room no. 204, 2nd floor, Anaesthesia department, Teerthanker Mahaveer medical college and research centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9465930003 |
| Fax |
|
| Email |
arvindsingh0511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Payal Jain |
| Designation |
Associate Professor |
| Affiliation |
Teerthanker Mahaveer medical college and research centre, Moradabad |
| Address |
Room no. 204, 2nd floor, Anaesthesia department, Teerthanker Mahaveer medical college and research centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9855567933 |
| Fax |
|
| Email |
Payalravi1408@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Singh Bissarwal |
| Designation |
Junior resident |
| Affiliation |
Teerthanker Mahaveer medical college and research centre, Moradabad |
| Address |
Room no. 204, 2nd floor, Anaesthesia department, Teerthanker Mahaveer medical college and research centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9465930003 |
| Fax |
|
| Email |
Arvindsingh0511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer medical college and research centre, Moradabad |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer medical college and research centre Moradabad |
| Address |
Room no. 204, 2nd floor, anaesthesia department, Teerthanker Mahaveer medical college and research centre, Moradabad, Dist- Moradabad, Uttar Pradesh PIN code 244001 |
| 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 Arvind Singh Bissarwal |
Teerthanker Mahaveer medical college and research centre, Moradabad |
Room no. 204, 2nd floor, anaesthesia department.
Moradabad
UTTAR PRADESH |
9465930003
arvindsingh0511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMU Moradabad Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Granisetron |
Injection Granisetron 3mg intravenously 15 minutes before spinal anesthesia. |
| Comparator Agent |
Intravenous Norepinephrine |
Intravenous Norepinephrine 10 mcg at the time of spinal anesthesia |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving written informed consent.
Patient posted for Infraumblical surgeries.
Age more than 60 years.
ASA 1 and 2(American Society of Anaesthesiologist). |
|
| ExclusionCriteria |
| Details |
Patients with known cardiac abnormalities, Hyperthyroidism, Monoamine oxidase inhibitor use.
Allergic to drugs used.
Contraindication to Spinal Anaesthesia. |
|
|
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 |
To compare Hemodynamic parameters(SBP,DBP, HR, MAP, PI) in both the groups.
To compare total consumption of rescue vasopressors and anticholinergics in both the groups. |
To compare Hemodynamic parameters(SBP,DBP, HR, MAP, PI) in both the groups.
To compare total consumption of rescue vasopressors and anticholinergics in both the groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare total number of patients requiring rescue vasopressors in both the groups.
To compare side effect in both the groups. |
To compare total number of patients requiring rescue vasopressors in both the groups.
To compare side effect in both the groups. |
|
|
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)
|
15/03/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Vasopressors have been conventionally used to prevent spinal induced hypotension but have there own set of side effects especially in cardiac compromised patients. 5HT3 antagonist (used for PONV routinely) response in prevention of spinal induced hypotension have recently been studied. There is a paucity of data comparing vasopressors with 5HT3 antagonists for prevention of spinal anaesthesia induced hypotension[SAIH], each class of drugs having its own pros and cons. Thus, this study will be conducted to compare these two different class of drugs i.e. Granisetron versus Norepinephrine to prevent SAIH in elderly group. |