| CTRI Number |
CTRI/2024/02/062601 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of ondansetron which is a drug used to treat vomiting, on spinal anaesthesia induced fall in blood pressure. |
|
Scientific Title of Study
|
Effect of ondansetron on spinal anesthesia induced hypotension |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fazil H |
| Designation |
MD Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department Of Anesthesiology
Amrita Vishwa Vidyapeetham
Health Sciences Campus
Amrita Institute of Medical Sciences
Elamakkara P.O.
Kochi - 682 041
Kerala, India
Ernakulam
KERALA
682041
India |
| Phone |
9072239462 |
| Fax |
|
| Email |
fazilhaleel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh K |
| Designation |
Associate professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department Of Anesthesiology
Amrita Vishwa Vidyapeetham
Health Sciences Campus
Amrita Institute of Medical Sciences
Elamakkara P.O.
Kochi - 682 041
Kerala, India
Ernakulam
KERALA
682041
India |
| Phone |
9847162134 |
| Fax |
|
| Email |
rajgokulam70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Fazil H |
| Designation |
MD Resident |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Department Of Anesthesiology
Amrita Vishwa Vidyapeetham
Health Sciences Campus
Amrita Institute of Medical Sciences
Elamakkara P.O.
Kochi - 682 041
Kerala, India
Ernakulam
KERALA
682041
India |
| Phone |
9072239462 |
| Fax |
|
| Email |
fazilhaleel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Amrita Institute Of Medical Sciences |
| Address |
Amrita Vishwa Vidyapeetham
Health Sciences Campus
Amrita Institute of Medical Sciences
Elamakkara P.O.
Kochi - 682 041
Kerala, India |
| 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 |
| DrFazil H |
Amrita Institute of Medical Sciences |
Department of anesthesiology
Amrita Institute of Medical Sciences
Elamakkara P.O.
Kochi - 682 041
Kerala, India
Ernakulam
KERALA |
9072239462
fazilhaleel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute Of Medical Sciences |
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 |
Normal saline |
For patients in the camparitor group single dose of normal saline 4 ml will be given intravenously |
| Intervention |
Ondansetron |
Single shot ondansetron will be give ten minutes before spinal anesthesia at a dose of 0.1mg/kg maximum of eight milligram intravenously. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 to 3 |
|
| ExclusionCriteria |
| Details |
1.Contraindication or a history of hypersensitivity to ONDANSETRON
2.Obstretric surgeries
3.Uncontrolled hypertension
4.Localized infection at the puncture site and patients with coagulopathies.
|
|
|
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 the incidence of hypotension (fall in mean arterial pressure more than 20% in the baseline values) between test and control groups. |
Immediately after spinal, at 5 min, 10 min, 15 min,30 min and every 30 min till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the recquirement for inotrops to treat hypotension
To find the usage of atropine and glycopyrrolate to treat bradycardia |
Before spinal after spinal,1 min after spinal 3 minutes after spinal,5 minutes after spinal ,10minutes after spinal,15 mintues after spinal 30mintues after spinal,every 30 min till surgery ends. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3 |
|
Date of First Enrollment (India)
|
13/02/2024 |
| 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="0"
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
|
Hypotension and bradycardia are the common side effects seen after spinal anesthesia. Multiple strategies are tested to prevent the post spinal anesthesia induced hypotension. Recently, ondansetron, a 5-HT3 antagonist commonly used as an antiemetic was found to be effective in preventing spinal anesthesia induced hypotension. The aim of this study is to evaluate the effect of ondansetron in the prevention of spinal anesthesia induced hypotension Following spinal anesthesia, hypotension results mainly from a decrease in systemic vascular resistance secondary to a blockage of sympathetic fibers and an increase in vagal tone. This reduction in venous return can trigger the Von Bezold-Jarisch (BJ) reflex, mediated by serotonin receptors (subtype 5-HT3), resulting in increased efferent vagal signaling and bradycardia, ultimately exacerbating hypotension Ondansetron is a drug employed as prophylaxis for Postoperative Nausea and Vomiting (PONV), whose antiemetic activity involves the selective inhibition of the 5-HT3 receptors. As a result, ondansetron can suppress the BJ reflex, and it has been postulated as a therapeutic strategy to prevent hypotension in patients undergoing spinal anesthesia Patients will be randomized using computer generated random sequence of numbers. On the day of surgery patient will be shifted to OT and all standard monitors would be attached. Peripheral IV line will be inserted. All the patients were preloaded with 500 mL of lactated Ringer’s solution IV. Patient’s peripheral oxygen saturation, blood pressure(systolic, diastolic, and mean arterial pressure), and electrocardiogram will be monitored. Basal values will be recorded. Group A- received 0.1mg/kg max upto 8mg ondansetron intravenously (IV) 10 min before spinal anesthesia. Group B- received 4 mL saline IV 10 min before spinal anesthesia The patients were placed in lying down lateral position, and dural puncture was performed at L3–L4 interspace under full aseptic precautions. A total volume of 15 mg of 0.5% hyperbaric bupivacaine was injected intrathecally and adjuvant opiods(fentanyl) at the discretion of the anesthesiologist. Supine position was adopted after the administration of spinal anesthesia. Parameters such as age, sex,height, weight, surgery timing and amount of iv fluids given would be included and level of spinal block The primary outcome was the proportion of patients with hypotension during surgery. Hypotension was defined as mean arterial pressure(MAP) below 20% of initial value. Secondary outcomes included the proportion of patients with bradycardia, vasopressors usage, and variations in blood pressure and Heart Rate (HR). Baseline Systolic Blood PressureDiastolic Blood Pressure MeanArterial Pressure Heart Rate values will be recorded, as well as after anxiolysis, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes after spinal anaesthesia and every 30 min till the end of surgery. Incidence of nausea and vomiting until shift from icu, fluid requirement ,level of spinal blockage were also noted. Care was also taken so that the surgeries are similar. |