| CTRI Number |
CTRI/2023/08/056866 [Registered on: 24/08/2023] Trial Registered Prospectively |
| Last Modified On: |
17/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effect of bous intravenous dose of Dexmedetomidine versus Magnesium Sulphate on induction dose of Propofol in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparing the effect of bolus intravenous Dexmedetomidine versus Magnesium Sulphate on induction dose of Propofol-A Randomised Controlled Trial |
| 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.HARSHANAA.G |
| Designation |
POSTGRADUATE |
| Affiliation |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
| Address |
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9176258393 |
| Fax |
|
| Email |
harshanaa.g@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANAND S |
| Designation |
PROFESSOR DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
| Address |
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9444486183 |
| Fax |
|
| Email |
dranandmurugan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR.HARSHANAA.G |
| Designation |
POSTGRADUATE |
| Affiliation |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
| Address |
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9176258393 |
| Fax |
|
| Email |
harshanaa.g@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam |
|
|
Primary Sponsor
|
| Name |
DR ANAND S |
| Address |
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam |
| Type of Sponsor |
Other [Self sponsor] |
|
|
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 |
| DRHARSHANAA G |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
Department of Anaesthesiology,Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam
Kancheepuram
TAMIL NADU |
9176258393
harshanaa.g@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Comittee for Student Research (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K40-K46||Hernia, (2) ICD-10 Condition: K35-K38||Diseases of appendix, (3) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (4) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, (5) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (6) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (7) ICD-10 Condition: N60-N65||Disorders of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PROPOFOL
DEXMEDETOMIDINE AND MANESIUM SULPHATE |
INJECTION PROPOFOL INTRAVENOUS ROUTE |
| Comparator Agent |
DEXMEDETOMIDINE
MAGNESIUM SULPHATE
NORMAL SALINE |
1.INJECTION DEXMEDETOMIDINE 0.5MCG/KG INTRAVENOUS IN 100ML NORMAL SSALINE FOR 10 MINS
2.INJECTION MAGNESIUM SULPHATE 50MG/KG INTRAVENOUSIN 100ML NORMAL SALINE FOR 10MINUTES
3.100 ML NORMAL SALINE INTRAVENOUS FOR 10 MINUTES |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. ASA Grade I and Grade II patients
b. Age 18 yrs –60yrs.
c. Elective surgeries
|
|
| ExclusionCriteria |
| Details |
a. Refusal of consent
b. Known or anticipated
difficult airway.
c. Emergency surgeries.
d. Pregnant patients.
e. Patients with heart
block
f. Patients on Beta
blockers
g. Bradycardia
h. BMI >30kg/m2
|
|
|
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 |
| For comparing the dose of Propofol needed during induction of anaesthesia after giving a bolus dose of Dexmedetomidine or Magnesium Sulphate or Normal saline in general anaesthesia |
Baseline,After Drug bolus,After propofol induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To check the intubation response between the three groups-heart rate,blood pressure,saturation.
b) Time required for TOF value to change from 0 to 1
|
Preintubation vitals,post intubation vitals at 1,2,3,5 minutes
Time required for recovery from muscle relaxant after intubation dose |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/09/2023 |
| 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
|
Propofol is a universally used induction agent. Despite it’s favourable profile, higher doses may be required which can cause adverse cardiorespiratory effects. Alpha-2 adrenoceptor agonists, such as dexmedetomidine, are known to possess amnesic, analgesic, sympatholytic, and antinociceptive properties, and therefore, can reduce the requirement of anesthetics and opioids intraoperatively. Administration of MgSO4 has also shown significant reduction in the perioperative requirement of propofol, opioids, and muscle relaxants.Our goal is to titrate the dose of propofol during induction till there is a loss of verbal response by giving a bolus of dexmedetomidine or magnesium sulphate or normal saline (control group) and to compare the intubation response in all three groups.
|