| CTRI Number |
CTRI/2024/06/069382 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Single dose of a drug will be given to the patients who are going for joint surgeries and their blood glucose level will be recorded periodically and compare. |
|
Scientific Title of Study
|
Effect of single preoperative dose of dexamethasone on postoperative random blood glucose in elective joint arthroplasty under subarachnoid block – An Observational 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 Navin Kumar Tiwari |
| Designation |
PG Resident |
| Affiliation |
Pt J.N.M.Medical College, Raipur, Chhattisgarh. |
| Address |
Department of anaesthesiology and pain medicine, Pt. J.N.M. Medical College, Raipur, Chhattisgarh.
Raipur
CHHATTISGARH
492001
India |
| Phone |
8602604069 |
| Fax |
|
| Email |
navin.tiwari2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjulata Tandan |
| Designation |
Associate Professor |
| Affiliation |
Pt. J.N.M. Medical College, Raipur |
| Address |
Department of anaesthesiology and pain medicine, Pt. J.N.M. Medical College, Raipur, Chhattisgarh.
Raipur
CHHATTISGARH
492001
India |
| Phone |
7587351857 |
| Fax |
|
| Email |
dr.manjutkgh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navin Kumar Tiwari |
| Designation |
PG Resident |
| Affiliation |
Pt. J.N.M. Medical College, Raipur. |
| Address |
Department of anaesthesiology and pain medicine, Pt. J.N.M. Medical College, Raipur, Chhattisgarh.
Raipur
CHHATTISGARH
492001
India |
| Phone |
8602604069 |
| Fax |
|
| Email |
navin.tiwari2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and pain medicine, Pt J.N.M. Medical College, Moudahapara, Raipur, Chhattisgarh, India PIN- 492001 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology and pain medicine, Pt J.N.M. Medical College, Raipur |
| Address |
In front of central jail, Moudhapara, Raipur C.G. Pincode:492001, INDIA |
| 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 Navin Kumar Tiwari |
Dr. Bhimrao Ambedkar Memorial Hospital |
Room no.- 349, 2nd floor, department of anaesthesiology and pain medicine, Raipur, India, PIN- 492001
Raipur
CHHATTISGARH |
8602604069
navin.tiwari2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pt J.N.M. Medical College, Raipur (CG) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 7||Osteopathic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
iv dexamethasone |
single preoperative dose of iv dexamethasone 8mg.
dose - 8mg dexamethasone drug
frequency- single dose has to be given.
route - intravenous
duration of intervention- 72 hours |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65 years
BMI less than 30kg/m2
ASA I & II
Duration of elective joint arthroplasty surgery less than equal to 2hrs
Â
|
|
| ExclusionCriteria |
| Details |
Patients with prediabetes, diabetes, uncontrolled hypertension and uncontrolled bleeding diathesis.
History of peptic ulcer disease or GERD.
Chronic use of steroid
Immunosuppression
Pregnancy
Hepatorenal dysfunction
Malignancy
Patients allergic to dexamethasone.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To record the changes in random blood glucose within first 72hrs of elective joint arthroplasty |
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the changes in random blood glucose with fasting blood glucose.
To record the time of onset, severity and incidence of post operative nausea and vomiting. (PONV) (PONV Intensity Score)
To assess the severity of postoperative pain. (VAS)
|
72 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/07/2024 |
| 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="0"
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
|
The thesis title Effect of single preoperative dose of dexamethasone on postoperative random blood glucose in elective joint arthroplasty under subarachnoid block – An Observational Study will be conducted in the department of anaesthesiology and pain medicine, Pt. J.N.M. Medical College and Dr. B.R.A.M. Hospital, Raipur (C. G.) after approval from Institutional Scientific & Ethics Committee. A total of 60 patients, under age group of 18-65 yrs of ASA physical status –I & ІІ will be included in this study. The patient’s blood glucose level will be recorded and then all the patients will be preloaded with intravenous balanced salt solution. Patient will receive iv dexamethasone 8mg and subarachnoid block will be given to patient and subsequently patients blood glucose wll be recordend at fixed time period. |