| CTRI Number |
CTRI/2021/09/036899 [Registered on: 27/09/2021] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study To Compare The Effect Of Giving Rocuronium Before verses Rocuronium After Checking Mask Ventilation On Effectiveness Of Face Mask Ventilation In Patients undergoing Elective surgery under General Anesthesia. |
|
Scientific Title of Study
|
To Compare The Effect Of Rocuronium Administration Before And After Checking Mask Ventilation On The Efficiency Of Face Mask Ventilation In Patients With Normal Airway. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEGHA |
| Designation |
DOCTOR |
| Affiliation |
Maulana Azad Medical College |
| Address |
A-24 SECOND FLOOR, VIKRAM NAGAR, FEROZ SHAH KOTLA, DEPARTMENT OF ANESTHESIA, B L TANEJA BLOCK, THIRD FLOOR, MAULANA AZAD MEDICAL COLLEGE, BAHADUR SHAH ZAFAR MARG, NEW DELHI-110002
New Delhi
DELHI
110002
India |
| Phone |
9999903738 |
| Fax |
|
| Email |
megha71293@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAPIL CHAUDHARY |
| Designation |
DOCTOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANESTHESIA, B L TANEJA BLOCK, THIRD FLOOR, MAULANA AZAD MEDICAL COLLEGE, BAHADUR SHAH ZAFAR MARG, NEW DELHI-1100002
New Delhi
DELHI
110002
India |
| Phone |
9871262699 |
| Fax |
|
| Email |
kapsdr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MEGHA |
| Designation |
DOCTOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
A-24 SECOND FLOOR, VIKRAM NAGAR, FEROZ SHAH KOTLA,DEPARTMENT OF ANESTHESIA, B L TANEJA BLOCK, THIRD FLOOR, MAULANA AZAD MEDICAL COLLEGE, BAHADUR SHAH ZAFAR MARG, NEW DELHI-110002
New Delhi
DELHI
110002
India |
| Phone |
9999903738 |
| Fax |
|
| Email |
megha71293@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
MAULANA AZAD MEDICAL COLLEGE, BAHADUR SHAH ZAFAR MARG, NEW DELHI-110002 |
| 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 |
| DR MEGHA |
Maulana Azad Medical College And LOK NAYAK HOSPITAL |
DEPARTMENT OF ANESTHESIOLOGY MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED LOK NAYAK HOSPITAL
New Delhi
DELHI |
9999903738
megha71293@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group E- injection Rocuronium 0.6mg/kg as first drug |
Injection Rocuronium 0.6mg/kg in 5ml of 0.9% saline will be given as first drug in a sequential manner when standard induction protocol will be followed. |
| Comparator Agent |
Group L- 5ml of 0.9% saline as first drug |
5ml of 0.9% saline as first drug and Injection Rocuronium 0.6mg/kg in 5ml of 0.9% saline as second drug after adequate mask ventilation is confirmed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL GRADE I, II. |
|
| ExclusionCriteria |
| Details |
1. PATIENTS REQUIRING RAPID SEQUENCE INTUBATION, AWAKE INTUBATION.
2. PATIENTS WITH RISK OF PULMONARY ASPIRATION, ALLERGY TO STUDY DRUG, HISTORY OF NEUROMUSCULAR DISORDER.
3.PATIENTS HAVING PREDICTORS OF DIFFICULT AIRWAY( INCLUDING BUT NOT LIMITED TO BMI MORE THAN OR EQUAL TO 30KG PER METER SQUARE, MALLAMPATTI CLASS 3 OR 4, BEARD, EDENTULOUS, OROFACIAL ANOMALY, MASS OR RADIATION CHANGES IN NECK, HISTORY OF SNORING OR SLEEP APNEA, LIMITATION IN MOUTH OPENING,NECK EXTENSION OR JAW PROTRUSION. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFICIENCY OF MASK VENTILATION AS DETERMINED BY AVERAGE EXPIRATORY TIDAL VOLUME AFTER DETECTING APNEA( CALCULATED AS AVERAGE OF EXPIRED TIDAL VOLUMES MEASURED AT 15,30,45,60 SECONDS AFTER DETECTING APNEA. |
AVERAGE OF EXPIRED TIDAL VOLUMES MEASURED AT 15,30,45,60 SECONDS AFTER DETECTING APNEA. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. GRADE OF MASK VENTILATION ASSESSED BY HAN SCALE AFTER APNEA.
2. EXPIRATORY MINUTE VENTILATION AFTER APNEA.
3.TIME INTERVAL BETWEEN ADMINISTRATION OF FIRST AND SECOND DRUG.
4.ADVERSE EVENTS,IF ANY: WITHDRAWAL RESPONSE TO FIRST AND SECOND DRUG, OXYGEN DESATURATION (SPO2 LESS THAN 94%). |
HAN Scale: over 60 seconds after apnea.
Expiratory Minute Ventilation: over 60 seconds after apnea.
Time Interval: Time of first drug and second drug.
Withdrawal: time of first drug and second drug.
Oxygen Desaturation: over 60 seconds after apnea.
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/10/2021 |
| 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 Study is being conducted to compare the effect of Rocuronium administration before and after checking mask ventialtion on the efficiency of face mask ventilation in patients with normal airway. Primary outcome assessed would be efficiency of mask ventilation as determined by average expiratory tidal volumes after detecting apnea. Other outcomes assessed would be grade of mask ventilation, expiratory minute ventilation after apnea, time interval between administration of first and second drug and adverse events, withdrawal response to first and second drugs. |