| CTRI Number |
CTRI/2025/03/083518 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing prophylactic intravenous Ondansetron versus Glycopyrrolate to prevent spinal hypotension |
|
Scientific Title of Study
|
A comparative study determining the effect of pre-emptive intravenous
Glycopyrrolate versus Ondansetron in preventing spinal hypotension in
patients undergoing elective inguinal hernioplasty at a tertiary care hospital
|
| 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 Krishna Susrutha Kocherlakota |
| Designation |
Post Graduate |
| Affiliation |
Kodagu institute of medical sciences |
| Address |
Department of Anaesthesiology,Major OT complex,Room no:202,Kodagu institute of medical sciences and teaching hospital, Near G T Circle Pin Code: 571201, Madikeri,Karnataka,India
Kodagu
KARNATAKA
571201
India |
| Phone |
7022564318 |
| Fax |
|
| Email |
susruthakocherlakota@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AIYAPPA D S |
| Designation |
Associate Professor |
| Affiliation |
Kodagu Institute of medical sciences |
| Address |
Department of Anaesthesiology,Major OT complex,Room no:202,Kodagu institute of medical sciences and teaching hospital, Near G T Circle Pin Code: 571201, Madikeri,Karnataka,India
Kodagu
KARNATAKA
571201
India |
| Phone |
9986336771 |
| Fax |
|
| Email |
draiyappads@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aiyappa D S |
| Designation |
Associate Professor |
| Affiliation |
Kodagu Institute of Medical Sciences and Teaching Hospital |
| Address |
Department of Anaesthesiology,Major OT complex,Room no:202,Kodagu institute of medical sciences and teaching hospital, Near G T Circle Pin Code: 571201, Madikeri,Karnataka,India
Kodagu
KARNATAKA
571201
India |
| Phone |
9986336771 |
| Fax |
|
| Email |
draiyappads@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,Major OT complex,Room no:202,Kodagu institute of medical sciences and teaching hospital, Near G T Circle Pin Code: 571201, Madikeri,Karnataka,India |
|
|
Primary Sponsor
|
| Name |
Kodagu Institute of medical sciences and teaching hospital |
| Address |
Kodagu institute of medical sciences and teaching hospital, Near G T Circle Pin Code: 571201, Madikeri,Karnataka |
| 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 Krishna Susrutha Kocherlakota |
Kodagu institute of medical sciences and teaching hospital |
Department of Anaesthesiology,Major OT complex,Room no:202,Kodagu institute of medical sciences and teaching hospital, Near G T Circle Pin Code: 571201, Madikeri,Karnataka,India
Kodagu
KARNATAKA |
7022564318
susruthakocherlakota@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,KODAGU INSTITUTE OF MEDICAL SCIENCES AND TEACHING HOSPITAL,MADIKERI,571201 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection GLYCOPYRROLATE O.2 milligrams Intravenous |
Administration of prophylactic intravenous injection GLYCOPYRROLATE
(0.2 mg) diluted with sterile water to 0.04mg/cc in a 5 ml clear syringe administered over 2 minutes duration just 5 minutes before postioning for subarachnoid block |
| Comparator Agent |
Injection ONDANSETRON 4 milligrams intravenously |
Administration of prophylactic intravenous Injection ONDANSETRON(4 mg) diluted with sterile water to 0.2 mg/cc in a 5 ml clear syringe administered over 2 minutes duration just 5 minutes before postioning for subarachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Elective unilateral inguinal hernioplasty surgeries under spinal anaesthesia
2.American Society of Anaesthesiologists Grade I and Grade II of male/female gender.
3.Patients aged between 18 to 60 years.
4.Patients with BMI less than 30 kg/m2.
5.Patients with height between 155 -170 centimeters |
|
| ExclusionCriteria |
| Details |
1. Patients on Beta blockers, Calcium channel blockers, and alpha 2 agonists
2. Gross spinal abnormality.
3. Infection at the site of lumbar puncture.
4. Pre-existing Hemorrhagic diathesis.
5. Pre-existing Neurological disorders.
6. History of allergy to the study drugs |
|
|
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 measure the effectiveness of pre emptive
intravenous ondansetron and glycopyrrolate in
prevention of spinal hypotension by measuring
the Mean Arterial Pressure(MAP) to assess the
incidence and severity of hypotension after
administration of spinal anesthesia |
Every 2 min for first 20 min
Every 5 min thereafter till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the total vasopressor requirement
after administration of spinal anaesthesia |
Number of doses of vasopressor drugs given
intraoperatively after the administration of spinal
anesthesia till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 4 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Spinal anaesthesia is an extensively used anaesthetic procedure owing to its technical simplicity, faster onset, and effective motor and sensory blockade. Hypotension is one of the most frequent complications during subarachnoid block due to the sympathetic blockade which sequentially decreases the systemic vascular resistance and cardiac output leading to hypotension. Prevention and prompt management of hypotension is of utmost importance to prevent organ ischemia. Sympathomimetics are usually administered reactively which is the administration of drugs after the appearance of spinal hypotension. A more logical approach is proactively which is giving the drugs preemptively to prevent the occurrence of hypotension following subarachnoid block. This pre-emptive or proactive approach has reduced the incidence and severity of spinal anaesthesia induced hypotension in many studies conducted worldwide. Glycopyrrolate is a quaternary amine with anti-muscarinic effects and has been successfully used in preventing spinal anaesthesia induced hypotension in the elderly population, undergoing abdominal and lower limb surgeries. Bezold Jarisch reflex (BJR) is mediated by stimulation of intracardiac mechanoreceptors and chemoreceptors. Peripheral serotonin receptors, 5-Hydroxytryptamine3 (5HT3), are also required for the activation of the Bezold Jarisch reflex. Ondansetron, a 5-Hydroxytryptamine3 (5HT3) receptor antagonist is reported to suppress bradycardia and hypotension by preventing this Bezold Jarisch reflex. In this study, we aim to determine the effect of pre-emptive intravenous Glycopyrrolate versus Ondansetron in preventing spinal hypotension in patients undergoing elective unilateral inguinal hernioplasty under subarachnoid block. |