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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

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