| CTRI Number |
CTRI/2025/02/080277 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare effect of intravenous injection ondansetron and injection granisetron on spinal anaesthesia induce hypotension and bradycardia. |
|
Scientific Title of Study
|
A comparative study of intravenous injection ondansetron and injection granisetron on spinal anaesthesia induce hypotension and bradycardia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patel Vidhi Mukeshbhai |
| Designation |
Post graduate Resident doctor in Anaesthesiology |
| Affiliation |
B.J. Medical College and Civil Hospital , Ahmedabad |
| Address |
F3, First floor, Department of anaesthesiology, Civil hospital,
Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India
Ahmadabad
GUJARAT
380016
India |
| Phone |
8200375449 |
| Fax |
|
| Email |
vidhi6319@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana Raval |
| Designation |
Professor(H.G) |
| Affiliation |
B.J. Medical College and Civil Hospital , Ahmedabad |
| Address |
F3, First floor, Department of anaesthesiology, Civil hospital,
Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373182 |
| Fax |
|
| Email |
drbhavanaraval@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavana Raval |
| Designation |
Professor(H.G) |
| Affiliation |
B.J. Medical College and Civil Hospital , Ahmedabad |
| Address |
F3, First floor, Department of anaesthesiology, Civil hospital,
Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373182 |
| Fax |
|
| Email |
drbhavanaraval@yahoo.com |
|
|
Source of Monetary or Material Support
|
| B.J.Medical College and Civil Hospital , Government of Gujurat,India. 380016 |
|
|
Primary Sponsor
|
| Name |
BJMedical college AhmedabadGovernment of Gujurat |
| Address |
7 th floor, Health and family welfare department , Sachivalay,
Gandhinagar,Gujarat,India.382010 |
| 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 vidhi mukeshbhai patel |
B.J.Medical College and Civil Hospital , Ahmedabad |
Operation Theatres in civil hospital Ahmedabad
Ahmadabad
GUJARAT |
8200375449
vidhi6319@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee , B.J.Medical College and Civil Hiospital , Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Medical and surgical |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Granisetron 1 mg given intravenous prophylacticaly 5 minutes prior to spinal anaesthesia |
Granisetron effectiveness in studying prevention of hypotension and bradycardia |
| Comparator Agent |
Inj Ondansetron 4 mg given intravenous prophylacticaly 5 minutes prior to spinal anaesthesia |
Ondansetron effectiveness in studying prevention of hypotension and bradycardia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologist (ASA) Classification grade I, II.
2. Patient willing to consent for surgery.
3. Weight of patient (40-60 kg). |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. History of allergy to local anaesthetic drugs and study drug.
3. Contraindications to spinal anaesthesia.
4. Patients with history of bleeding disorders or on anticoagulant therapy.
5. American Society of Anaesthesiologist (ASA) Classification III, IV and V.
6. Emergency surgeries. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study is aimed to compare prevention of spinal anaesthesia induced hypotension and bradycardia in both drug groups. |
This study is aimed to compare incidence of hypotension and bradycardia in both drug groups intra operative and postoperative for upto 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total dose of atropine & mephentermine required intra operatively. |
Any time of hypotension or bradycardia during intra op requirements of atropine & mephentermine. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
20/02/2025 |
| 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="0"
Months="6"
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
|
Spinal anaesthesia is most popular mode of anaesthesia for both elective and emergency procedures in abdomen and lower limb surgeries. The most common hemodynamic adverse following spinal anaesthesia are hypotension and bradycardia.Hypotension results primarily from decreased systemic vascular resistance and central venous pressure from sympathetic block, whereas bradycardia is secondary to a relative parasympathetic dominance, increased baroreceptor activity or a result of the Bazold-Jarisch-Reflex (BJR). This reflex is elicited by stimulation of peripheral serotonin receptors 5- Hydroxytryptamine (5-HT3 type) which are both mechanosensitive and chemosensitive.Stimulation of cardiac chemoreceptors in the heart by decreased venous return increases the parasympathetic activity and decreases the sympathetic activity resulting in vasodilatation and bradycardia. This study concentrated on two 5HT3 receptor antagonists, which can minimise the occurrence of hypotension and bradycardia after spinal anaesthesia. They are Ondansetron and Granisetron which are selective 5- HT3 receptor antagonists. |