| CTRI Number |
CTRI/2025/08/092231 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How a Single Dose of IV Dexmedetomidine Affects Blood Sugar Levels During Spinal Anesthesia in Elective Surgeries |
|
Scientific Title of Study
|
Evaluating the effect of single
dose intravenous dexmedetomidine on blood glucose levels of patient
undergoing elective surgeries under spinal anaesthesia |
| 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 Anjali sharma |
| Designation |
Junior resident |
| Affiliation |
Srms ims bareilly |
| Address |
Department Of Anaesthesia Shri Ram Murti Smarak Institute of Medical Sciences Bareilly
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
7500947110 |
| Fax |
|
| Email |
anjali1111m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwadeep singh |
| Designation |
Professor |
| Affiliation |
Srms ims bareilly |
| Address |
Department Of Anaesthesia Shri Ram Murti Smarak Institute of Medical Sciences Bareilly
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9927770078 |
| Fax |
|
| Email |
Vishwadeepvishen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwadeep singh |
| Designation |
Professor |
| Affiliation |
Srms ims bareilly |
| Address |
Department Of Anaesthesia Shri Ram Murti Smarak Institute of Medical Sciences Bareilly
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9927770078 |
| Fax |
|
| Email |
Vishwadeepvishen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri ram murti smarak institute of medical
science bhojipura bareilly uttar pradesh 243202 |
|
|
Primary Sponsor
|
| Name |
Shri Ram Murti Smarak Institute of Medical Sciences |
| Address |
Shri Ram Murti Smarak institute of medical sciences, Bhojipura, Bareilly |
| 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 |
| Dr Vishwadeep Singh |
Shri Ram Murti Smarak Institute of Medical Sciences |
Department Of Anaesthesia Shri Ram Murti Smarak Institute of Medical Sciences Bareilly
Bareilly
UTTAR PRADESH |
7500947110
Vishwadeepvishen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Infused with 0.9% normal saline 100ml |
26 subjects were infused with 0.9% normal saline 100ml over 10 minutes. |
| Intervention |
Infused with inj. Dexmedetomidine at
1mcg/kg in 100 ml NS |
26 Subjects were infused with inj. Dexmedetomidine at the dose of
1mcg/kg in 100 ml NS over 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 60 years
ASA grade 1 and 2
Either sex male or female
The patient undergoing abdominal and lower limb surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Age less than 18 and more than 65 years
History of psychiatric diseases and traumatic brain injury
Patient on beta blockers
Multiple comorbidities
Pregnancy
Known allergy to dexmedetomidine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of inj. Dexmedetomidine at the dose of 1mcg/kg in 100 ml NS over 10 minutes on the levels of blood glucose of patients undergoing elective surgeries under spinal anaesthesia.
|
Hemodynamic parameters HR, SBP, DBP, MAP will be recorded at baseline than after 1 min ,3 min,5min,10 min after infusion of inj. Dexmedetomidine at the dose of 1mcg/kg in 100 ml NS over 10 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe side effects |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
18/08/2025 |
| 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
|
This study will carried out on 52 patient in the age group of 18 to 60 years of either sex ASA physical status I and II who will be undergoing elective surgery . The patient will be divided into 2 groups which will receive single dose intravenous dexmedetomidine 1mcg/kg in100ml NS over 10 min and other group will infused with 0.9% normal saline 100ml over 10 min .The primary outcome of the study is to compare the blood sugar level intraoperatively till 24 hours and the secondary outcome include the hemodynamics and incidence of adverse effect if any |