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
|
|
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
|
|
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. |