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CTRI Number  CTRI/2021/10/037145 [Registered on: 06/10/2021] Trial Registered Prospectively
Last Modified On: 05/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A STUDY TO EVALUATE THE ROLE OF MIDAZOLAM BEFORE INDUCTION ON THE EASE OF FACE MASK VENTILATION IN PATIENTS UNDERGOING ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA 
Scientific Title of Study   TO EVALUATE THE ROLE OF MIDAZOLAM PREMEDICATION IN FACILITATING FACE MASK VENTILATION DURING INDUCTION OF 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  ROSHITA SINGH 
Designation  DOCTOR 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIA,BL TANEJA BLOCK, THIRD FLOOR, MAULANA AZAD MEDICAL COLLEGE,BAHADUR SHAH ZAFAR MARG, NEW DELHI-110002

New Delhi
DELHI
110002
India 
Phone  9643037191  
Fax    
Email  anesthesia.roshita.2020@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  KAPIL CHAUDHARY 
Designation  DOCTOR 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  DEPT OF ANESTHESIA, B L TANEJA BLOCK, THIRD FLOOR. MAULANA AZAD MEDICAL COLLEGE, BAHADUR SHAH ZAFAR MARG, NEW DELHI-110002 New Delhi DELHI 110002 India

New Delhi
DELHI
110002
India 
Phone  9871262699  
Fax    
Email  Kapsdr@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  ROSHITA SINGH 
Designation  DOCTOR 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  B-25, SECOND FLOOR, B BLOCK, VIKRAM NAGAR FEROZE SHAH KOTLA, NEW DELHI 110002, DEPT OF ANAESTHESIA, MAULANA AZAD MEDICAL COLLEGE,BAHADUR SHAH ZAFAR MARG, NEW DELHI-110002

New Delhi
DELHI
110002
India 
Phone  9643037191  
Fax    
Email  anesthesia.roshita.2020@gmail.com  
 
Source of Monetary or Material Support  
MAULANA AZAD MEDICAL COLLEGE, NEW DELHI 
 
Primary Sponsor  
Name  MAULANA AZAD MEDICAL COLLEGE NEW DELHI 
Address  MAULANA AZAD MEDICAL COLLEGE. BAHADUR SHAH ZAFAR MARG. NEW DELHI-110002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ROSHITA SINGH  MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL   DEPARTMENT OF ANAESTHESIOLOGY MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED LOK NAYAK HOSPITAL,NEW DELHI-110002
Central
DELHI 
9643037191

anesthesia.roshita.2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INJECTION MIDAZOLAM 0.035mg/kg intravenous   INJECTION MIDAZOLAM 0.035mg/kg in 3ml of NORMAL SALINE 
Comparator Agent  NORMAL SALINE 0.9%  3ml NORMAL SALINE INTRAVENOUS  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL
GRADE I, II 
 
ExclusionCriteria 
Details  Patients requiring rapid sequence intubation
Patients requiring awake intubation.
Patients with risk of pulmonary aspiration
Patients having allergy to the midazolam
Patients having current cervical spine disease or history of cervical spine surgery
Patients with BMI ≥ 30kg/m2
Patients with history of sleep apnea
Patients with craniofacial anomaly
Patients having any contraindications to sedative premedication 
 
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 
Difficulty of face mask ventilation assessed by Warters grading scale after study drug administration  Difficulty of face mask ventilation assessed by warters grading scale 1 min after giving muscle relaxant vecuronium. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of difficult mask ventilation (Warters scale ≥2) after study drug administration.
The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.
Dose of propofol required for induction of anaesthesia.
Bispectral index (BIS) values measured during mask ventilation after study drug administration.
Correlation between BIS values and Warters scale during mask ventilation after study drug administration.
Adverse effects: incidence of hypotension or bradycardia during study period. 
3 MINUTES 
Incidence of difficult mask ventilation (Warters scale ≥2) after study drug administration.
The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.
Dose of propofol required for induction of anaesthesia.
Bispectral index (BIS) values measured during mask ventilation after study drug administration.
Correlation between BIS values and Warters scale during mask ventilation after study drug administration.
Adverse effects: incidence of hypotension or bradycardia during study period. 
3 MINUTES 
Incidence of difficult mask ventilation after study drug administration.
The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.
Dose of propofol required for induction of anaesthesia.
Bispectral index (BIS) values measured during mask ventilation after study drug administration.
Correlation between BIS values and Warters scale during mask ventilation after study drug administration.
Adverse effects: incidence of hypotension or bradycardia during study period. 
3MINUTES 
Incidence of difficult mask ventilation after study drug administration.
The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.
Dose of propofol required for induction of anaesthesia.
Bispectral index (BIS) values measured during mask ventilation after study drug administration.
Correlation between BIS values and Warters scale during mask ventilation after study drug administration.
Adverse effects: incidence of hypotension or bradycardia during study period. 
3MINUTES 
Incidence of difficult mask ventilation (Warters scale ≥2) after study drug administration.
The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.
Dose of propofol required for induction of anaesthesia.
Bispectral index (BIS) values measured during mask ventilation after study drug administration.
Correlation between BIS values and Warters scale during mask ventilation after study drug administration.
Adverse effects: incidence of hypotension or bradycardia during study period. 
3MINUTES 
Incidence of difficult mask ventilation (Warters scale ≥2) after study drug administration.
The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.
Dose of propofol required for induction of anaesthesia.
Bispectral index (BIS) values measured during mask ventilation after study drug administration.
Correlation between BIS values and Warters scale during mask ventilation after study drug administration.
Adverse effects: incidence of hypotension or bradycardia during study period. 
3MINUTES 
Incidence of difficult mask ventilation (Warters scale ≥2) after study drug administration.
The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.
Dose of propofol required for induction of anaesthesia.
Bispectral index (BIS) values measured during mask ventilation after study drug administration.
Correlation between BIS values and Warters scale during mask ventilation after study drug administration.
Adverse effects: incidence of hypotension or bradycardia during study period. 
3 MINUTES 
Incidence of difficult mask ventilation (Warters scale ≥2) after study drug administration.
The anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.
Dose of propofol required for induction of anaesthesia.
Bispectral index (BIS) values measured during mask ventilation after study drug administration.
Correlation between BIS values and Warters scale during mask ventilation after study drug administration.
Adverse effects: incidence of hypotension or bradycardia during study period. 
3MINUTES 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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   Phase 4 
Date of First Enrollment (India)   15/10/2021 
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   None yet 
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 evaluate the effect of Midazolam administration before induction on the ease of face mask ventilation in patients with normal airway. Primary outcome assessed would be difficulty of face mask ventilation assessed by Warters grading scale after study drug administration. Other outcomes assessed would be Incidence of difficult mask ventilation (Warters scale >2) after study drug administration, Anxiety and sedation levels before and after study drug administration: assessed by Numerical Rating Scale & Modified Observer’s Assessment of Alertness / Sedation Scale, respectively.Dose of propofol required for induction of anaesthesia,
Bispectral index (BIS) values measured during mask ventilation after study drug administration, Correlation between BIS values and Warters scale during mask ventilation after study drug administration and adverse effects like incidence of hypotension or bradycardia during study period.
 
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