| CTRI Number |
CTRI/2021/03/031948 [Registered on: 12/03/2021] Trial Registered Prospectively |
| Last Modified On: |
11/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the efficacy of Propofol and Dexmedetomidine in controlling painful stress while skull pin insertion, used for position of head during brain tumor surgeries. propofol and dexmedetomidine are drugs used for starting of anaesthesia and maintaining blood pressure,heart rate during surgery" |
|
Scientific Title of Study
|
Comparative Study Between Propofol Infusion And Dexmedetomidine Infusion On Hemodynamic Response And Blood Glucose Levels During Scalp Pin Insertion In Intracranial Tumor Surgeries†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramya Varda |
| Designation |
MD Student |
| Affiliation |
Institute Of Medical Sciences And SUM Hospital |
| Address |
IMS & SUM Hospital
Dept. Of Anaesthesiology,Pain,Palliative And Critical Care
K-8 , kalinga nagar
Bhubaneswar, Odisha
IMS & SUM Hospital
Dept. Of Anaesthesiology,Pain,Palliative And Critical Care
K-8 , kalinga nagar
Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9849240405 |
| Fax |
|
| Email |
ramyavarda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Swastika Swaro |
| Designation |
Professor and Guide |
| Affiliation |
Institute Of Medical Sciences And SUM Hospital |
| Address |
Institute Of Medical Sciences And SUM Hospital
Dept. Of Anaesthesiology,Pain,Palliative And Critical Care
K-8 , kalinga nagar
Bhubaneswar, Odisha
Institute Of Medical Sciences And SUM Hospital
Dept. Of Anaesthesiology,Pain,Palliative And Critical Care
K-8 , kalinga nagar
Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9861628628 |
| Fax |
|
| Email |
drswastika81@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Swastika Swaro |
| Designation |
Professor and Guide |
| Affiliation |
Institute Of Medical Sciences And SUM Hospital |
| Address |
Institute Of Medical Sciences And SUM Hospital
Dept. Of Anaesthesiology,Pain,Palliative And Critical Care
K-8 , kalinga nagar
Bhubaneswar, Odisha
Institute Of Medical Sciences And SUM Hospital
Dept. Of Anaesthesiology,Pain,Palliative And Critical Care
K-8 , kalinga nagar
Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9861628628 |
| Fax |
|
| Email |
drswastika81@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute Of Medical Sciences And SUM Hospital
Dept. Of Anaesthesiology,Pain,Palliative And Critical Care
K-8 , kalinga nagar
Bhubaneswar, Odisha |
|
|
Primary Sponsor
|
| Name |
Dr Ramya Varda |
| Address |
IMS & SUM HOSPITAL
Dept. Of Anaesthesiology,Pain,Palliative And Critical Care
K 8
kalinga nagar
Bhubaneswar
Odisha 751003 |
| Type of Sponsor |
Other [self ] |
|
|
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 Ramya Varda |
Institute Of Medical Sciences and SUM Hospital |
Dept. Of Anaesthesiology,Pain,Palliative And Critical Care
K-8 , kalinga nagar
Bhubaneswar, Odisha
Khordha
ORISSA |
9849240405
ramyavarda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS AND SUM HOSPITAL Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D332||Benign neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine infusion |
Intravenous infusion at 1 mcg/kg/hr started after endotracheal intubation and stopped soon after skull pin insertion. |
| Intervention |
propofol infusion |
intravenous infusion at 150 mcg/kg/min started after endotracheal intubation and stopped soon after skull pin insertion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients who have given consent for the study
2.Patients posted for elective intracranial tumor surgeries
3. ASA Grade 1 & 2
4.Age 18-60 years
|
|
| ExclusionCriteria |
| Details |
1. Known history of allergies to Propofol, Dexmedetomidine
2. Baseline Heart rate <60
3. Known cases of heart block
4. Known cases of Coronary Artery Disease
5. Known case of Diabetes mellitus type 2, hypertension, pregnancy
6. Previous craniotomy incision
7. Emergency Operations
8. ASA Grade 3 and 4
9. Patients on steroids, psychoactive medications, alpha 2 agonists or antagonists, beta blockers
10. Patients with any known endocrine disorders
11. Patients with hepatic impairment
12. Difficult intubation or repeated attempts of intubation
|
|
|
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 |
| compare the effects of propofol infusion and dexmedetomidine infusion on blood glucose levels |
baseline (pre operative)
0 min (just before pin insertion)
20 min after pin insertion
40 min after pin insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The hemodynamic response after propofol infusion and dexmedetomidine infusion |
Baseline (pre operative)
0 min (just before pin insertion)
1 in after pin insertion
3 min after pin insertion
5 min after pin insertion |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/03/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This current study is a Randomised, double blinded, parallel group, prospective single centric study to observe whether Propofol is better than Dexmedetomidine in abating metabolic stress and provide optimum adequate depth of anaesthesia by monitoring the blood glucose levels, an indirect marker of metabolic stress during the skull pin insertion. Skull pin insertion is rather a painful stimulus to the patient and demands adequate optimisation of hemodynamics. The primary outcome is to compare the effects of Propofol infusion and dexmedetomidine infusion on blood glucose levels during skull pin insertion Secondary outcome is to observe the hemodynamic response after Propofol infusion and Dexmedetomidine infusion during skull pin insertion |