| CTRI Number |
CTRI/2021/07/034904 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
14/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Midazolam and Dexmedetomidine as sedative and for decreasing anxiety in general anaesthesia in controlled hypertensive patients undergoing elective surgery |
|
Scientific Title of Study
|
COMPARISON OF PREMEDICATION WITH MIDAZOLAM AND DEXMEDETOMIDINE ON SEDATION AND ANXIETY IN CONTROLLED HYPERTENSIVE PATIENTS UNDERGOING ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NITHISHA ROY |
| Designation |
POST GRADUATE |
| Affiliation |
ABVIMS AND DR RML HOSPITAL, NEW DELHI |
| Address |
ABVIMS and DR.RML HOSPITAL ,BABA KHARAG SINGH MARG ,NEW DELHI
NEW DELHI
110001
New Delhi
DELHI
110001
India |
| Phone |
8806835587 |
| Fax |
|
| Email |
nithisharoy11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ALKA GUPTA |
| Designation |
PROFESSOR |
| Affiliation |
ABVIMS and Dr.RML Hospital |
| Address |
DEPARTMENT OF ANAESTHESIA,ATAL BIHARI VAJPAYEE INSTITUTE OF MEDICAL SCIENCES AND DR RAM MANOHAR LOHIA HOSPITAL,BABA KHARAG SINGH MARG ,NEW DELHI
NEW DELHI
DELHI
110001
New Delhi
DELHI
110001
India |
| Phone |
9871653335 |
| Fax |
|
| Email |
Alkagupta_rml@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
NITHISHA ROY |
| Designation |
POST GRADUATE |
| Affiliation |
ABVIMS and Dr.RML Hospital |
| Address |
DEPARTMENT OF ANAESTHESIA,ATAL BIHARI VAJJPAYEE INSTITUTE OF MEDICAL SCIENCE AND DR RAM MANOHAR LOHIA HOSPITAL,BABA KHARAG SINGH MARG ,NEW DELHI,INDIA
New Delhi
DELHI
110001
India |
| Phone |
8806835587 |
| Fax |
|
| Email |
nithisharoy11@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIA,ABVIMS AND DR RML HOSPITAL |
|
|
Primary Sponsor
|
| Name |
ABVIMS DR RML HOSPITAL |
| Address |
BABA KHARAG SINGH MARG,NEW DELHI |
| 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 |
| NITHISHA ROY |
ATAL BHIHARI VAJPAYEE INSTITUTE OF MEDICAL SCIENCES AND DR RAM MANOHAR LOHIA HOSPITAL |
DEPARTMENT OF ANAESTHESIA
NEW DELHI
New Delhi
DELHI |
8806835587
nithisharoy11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE ,PGIMER ,DR RAM MANOHAR LOHIA HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
1mcg/kg in 100ml normal saline over 10 minutes. |
| Comparator Agent |
Drugs |
Comparison of Midazolam and dexmedetomidine as a premedication for sedation and anxiety |
| Intervention |
Midazolam |
0.02mg/kg I.v in 100 ml Normal saline over 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 20 to 75 years
2.ASA 2 |
|
| ExclusionCriteria |
| Details |
1.Renal and hepatic dysfunction
2.cardiovascular diseases
3.uncontrolled hypertensive patients
4.Pregnant or lactating
5.opiod use
6.history of drug sensitivity,seizures,psychiatric disorders
7.patient on beta-blockers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.sedation scoring by RSS at 5 minutes interval
2.Anxiety level using VAS-A at 5 minutes interval |
1.sedation scoring by RSS at 5 minutes interval
2.Anxiety level using VAS-A at 5 minutes interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hemodynamic measurements at 5 minutes interval
Mean arterial pressure ,systolic blood pressure,diastolic blood pressure
Heart rate
Peripheral oxygen saturation
Respiratory rate |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
22/07/2021 |
| 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 is a randomized competitive study on premedication with midazolam and Dexmedetomidine on sedation and anxiety in controlled hypertensive patients undergoing elective surgery under general anaesthesia with a sample size of 100 and place of study is ABVIMS and Dr Rml hospital ,New Delhi ,India.Primary outcome include sedation scoring by RSS and anxiety level by using VAS-A -A |