| CTRI Number |
CTRI/2022/05/042507 [Registered on: 12/05/2022] Trial Registered Prospectively |
| Last Modified On: |
10/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare the effects of ondansetron and glycopyrrolate to prevent the fall in blood pressure and heart rate following spinal anaesthesia in patients undergoing lower limb orthopaedic surgery |
|
Scientific Title of Study
|
A comparative study of prophylactic ondansetron and glycopyrrolate in prevention of spinal induced hypotension and bradycardia in patients undergoing lower limb orthopaedic surgery
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Palas halder |
| Designation |
PGT |
| Affiliation |
Calcutta National medical college |
| Address |
Halisahar new barui para,
p.s bizpore,p.o.halisahar,north 24 parganas,west bengal.
North Twentyfour Parganas
WEST BENGAL
713134
India |
| Phone |
7003669074 |
| Fax |
|
| Email |
dr.palas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sudeshna Bhar Kundu |
| Designation |
Associate professor,Department of anaesthesiology |
| Affiliation |
Calcutta National medical college |
| Address |
Baalajee Ganges,Flat no.D304,Bidhan nagar road,kolkata700067,west bengal
Baalajee Ganges,Flat no.D304,Bidhan nagar road,kolkata700067,west bengal
Kolkata
WEST BENGAL
700067
India |
| Phone |
8777725424 |
| Fax |
|
| Email |
sudeshna04cmc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Palas halder |
| Designation |
PGT |
| Affiliation |
Calcutta National medical college |
| Address |
Halisahar new barui para,
p.s bizpore,p.o.halisahar,north 24 parganas,west bengal.
North Twentyfour Parganas
WEST BENGAL
713134
India |
| Phone |
7003669074 |
| Fax |
|
| Email |
dr.palas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Calcutta National Medical College,32 gorachand road,kolkata-700014,west bengal |
|
|
Primary Sponsor
|
| Name |
Caicutta National Medical College And Hospital |
| Address |
32,Gorachand road,kolkata-700014,west bengal |
| 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 |
| DrPalas Halder |
Calcutta national medical college and hospital |
32,gorachand road,beniapukur,kolkata-700014,3rd floor,surgery block, Orthopaedic operation theatre
Kolkata
WEST BENGAL |
7003669074
dr.palas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE CAICUTTA NATIONAL MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M844||Pathological fracture, not elsewhere classified, (2) ICD-10 Condition: M844||Pathological fracture, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Glycopyrrolate |
0.2 mg( diluted to 2 ml normal saline) IV route 5 minute before spinal anaesthesia |
| Intervention |
Ondansetron |
4mg(2 ml) iv route 5 minute brfore spinal anaesthesia |
| Comparator Agent |
placebo |
2ml normal saline IV route 5 minute before spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18-45 years, either sex, ASA physical status I & II undergoing elective lower limb orthopaedic surgeries under spinal anaesthesia will be included in this
study. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
(i) Patients having contraindications for spinal anaesthesia like lack of consent, raised intra cranial tension, infection at local site, severe aortic stenosis, coagulopathy, cardiovascular instability.
(ii) Patients with known allergy to study drugs
(iii) Patients with BMI > 30 kg/m²
(iv) Patients having height < 150 cm
(v) Patients ASA physical status III or more
(vi) Patients having major cardiovascular,
respiratory, renal, hepatic, metabolic, neurological or endocrine diseases.
(vii) Patients with glaucoma
(viii) Patients receiving any antihypertensive, vasodilator, antiarrhythmic or antiemetic
agents
(ix) Patients requiring general anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of hypotension intraoperatively after giving spinal anaesthesia |
19 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of bradycardia, total phenylephrine requirement and total fluid requirement in the intraoperative period. |
19 months |
|
|
Target Sample Size
|
Total Sample Size="123"
Sample Size from India="123"
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)
|
25/05/2022 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective, parallel group, double blind placebo-controlled
study will be conducted on 123
patients of age 18-45 years, either sex, ASA physical status I & II
undergoing elective lower limb orthopaedic surgeries under spinal anaesthesia.
Patients will be randomly divided into 3 groups, Group O
Group G and Group N. Patients in
Group O will receive inj. ondansetron 4 mg
(2 ml) IV, patients in Group G
will receive inj. glycopyrrolate 0.2 mg
(2 ml) IV and patients in Group N will receive normal saline 2 ml IV, 5 minutes
prior to spinal anaesthesia. Heart rate, blood pressure, phenylephrine and
intravenous fluid requirement will be recorded intraoperatively and
postoperatively. The study will be conducted to compare ondansetron and glycopyrrolate in prevention of spinal induced hypotension and bradycardia in patients undergoing lower limb orthopaedic surgery. |