CTRI Number |
CTRI/2019/05/018920 [Registered on: 03/05/2019] Trial Registered Prospectively |
Last Modified On: |
25/01/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
To compare the effect of the drugs, midazolam (in low dose) and midazolam with fentanyl, on muscle movement caused by another drug, etomidate, when it is used for giving anaesthesia before surgery. |
Scientific Title of Study
|
Comparison of pretreatment with low dose midazolam and fentanyl with midazolam alone on occurrence of etomidate induced myoclonus in patients for surgery under general anesthesia |
Secondary IDs if Any
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prof Dr Nisha Kachru |
Address |
Department of Anaesthesiology
P.G.I.M.E.R. & Dr. RML Hospital
New Delhi – 110001
Central DELHI 110001 India |
Phone |
9810488435 |
Fax |
|
Email |
nishakachru@yahoo.co.uk |
|
Details Contact Person Scientific Query
|
Name |
Prof Dr Nisha Kachru |
Address |
Department of Anaesthesiology
P.G.I.M.E.R. & Dr. RML Hospital
New Delhi – 110001
Central DELHI 110001 India |
Phone |
9810488435 |
Fax |
|
Email |
nishakachru@yahoo.co.uk |
|
Details Contact Person Public Query
|
Name |
Dr Khaise Hareed |
Address |
Department of Anaesthesiology
P.G.I.M.E.R. & Dr. RML Hospital
New Delhi – 110001
Central DELHI 110001 India |
Phone |
9995138757 |
Fax |
|
Email |
khaisehareed@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
PGIMER & Dr RML Hospital,
Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001 |
|
Primary Sponsor
|
Name |
Department of Anesthesiology |
Address |
PGIMER & Dr. RML Hospital,
New Delhi - 110001 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Nisha Kachru |
PGIMER & Dr RML Hospital |
Department of Anesthesiology,
Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001
Central |
9810488435
nishakachru@yahoo.co.uk |
|
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 |
Other specified misadventures during surgical and medical care |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
low dose midazolam and fentanyl |
low dose midazolam and fentanyl will be given before administration of etomidate |
Comparator Agent |
midazolam |
midazolam will be given before administration of etomidate |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
American Society of Anesthesiology physical status I and II adult patients undergoing elective surgical procedures under general anaesthesia |
|
ExclusionCriteria |
Details |
Patients with
1. History of any neurological disease
2. Adrenal cortical dysfunction
3. History of allergy to study drugs
4. Those having received any sedative within previous 24 hours
5. Pregnant or lactating women |
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Occurrence of myoclonic movements after etomidate injection. |
Upto 90 seconds after etomidate injection |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study the effect of pretreatment with low dose midazolam with fentanyl and midazolam alone on heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation |
After test drug administration and then every minute for 5 minutes |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
03/05/2019 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Not applicable at this stage |
Brief Summary
|
Hypothesis: Pretreatment with low dose midazolam and fentanyl is comparable to midazolam alone in reducing the occurrence of etomidate induced myoclonus in patients for surgery under general anesthesia. Aim: To evaluate the efficacy of pretreatment with low dose midazolam and fentanyl and midazolam alone in reducing the occurrence of etomidate induced myoclonus in patients for surgery under general anesthesia. Sample size: 60 Patients will be administered drugs used for the study based on the group he/she is assigned to: Group MF: The patients will receive pretreatment with midazolam 0.015mg/kg in a volume of 5ml normal saline, followed by fentanyl 1mcg/kg in a volume of 5ml normal saline. Group M: The patients will receive pretreatment with midazolam 0.03mg/kg in a volume of 5ml normal saline, followed by 5ml of normal saline.The occurrence and severity of myoclonus will be graded by the scale given by Doenicke et al as follows: 0 = no myoclonus 1 = mild myoclonus – a short movement of a body segment (a finger or a shoulder) 2 = moderate myoclonus – slight movement of two different muscles or muscle groups of the body (face and leg) 3 = severe myoclonus – intense clonic movement in two or more muscle groups (fast abduction of a limb) Any complications will also be recorded. Heart rate, blood pressure and oxygen saturation will be recorded immediately after test drug injection and at every minute for 5 minutes at which point the study period ends. |