| CTRI Number |
CTRI/2023/03/051068 [Registered on: 27/03/2023] Trial Registered Prospectively |
| Last Modified On: |
25/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A STUDY TO FIND OUT IF PREMEDICATION WITH MIDAZOLAM BEFORE MASK VENTILATION FACILITATES EASE OF VENTILATION BY FACE MASK IN PATIENTS WITH SUSPECTED DIFFICULT BAG AND MASK VENTILATION:A RANDOMISED CONTROL TRIAL |
|
Scientific Title of Study
|
A STUDY TO EVALUATE THE EFFECT OF MIDAZOLAM PREMEDICATION ON MASK VENTILATION IN PATIENTS WITH ANTICIPATED DIFFICULT BAG AND MASK VENTILATION:A RANDOMISED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MRIGAKHI BORDOLOI |
| Designation |
POSTGRADUATE TRAINEE GAUHATI MEDICAL COLLEGE |
| Affiliation |
GAUHATI MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPT OF ANAESTHESIOLOGY GAUHATI MEDICAL COLLEGE BHANGAGARH GUWAHATI KAMRUP ASSAM PIN 781032
NEAR DOWNTOWN HOSPITAL BORMOTORIA DR ZAKIR HUSSAIN PATH BYELANE9 RUPKONWAR PATH HOUSE NO 1000
Kamrup
ASSAM
781032
India |
| Phone |
8752861728 |
| Fax |
|
| Email |
mrigakhijmc2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRANAB KALITA |
| Designation |
ASSISSTANT PROFESSOR GAUHATI MEDICAL COLLEGE |
| Affiliation |
GAUHATI MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPT OF ANAESTHESIOLOGY GAUHATI MEDICAL COLLEGE BHANGAGARH GUWAHATI KAMRUP PIN 781032
NEAR DOWNTOWN HOSPITAL BORMOTORIA DR ZAKIR HUSSAIN PATH BYELANE9 RUPKONWAR PATH HOUSE NO 1000
Kamrup
ASSAM
781032
India |
| Phone |
7002181200 |
| Fax |
|
| Email |
11980pran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MRIGAKHI BORDOLOI |
| Designation |
POSTGRADUATE TRAINEE,GAUHATI MEDICAL COLLEGE |
| Affiliation |
GAUHATI MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPT OF ANAESTHESIOLOGY,GAUHATI MEDICAL COLLEGE,BHANGAGARH,GUWAHATI,KAMRUP,PIN 781032
NEAR DOWNTOWN HOSPITAL,BORMOTORIA,DR ZAKIR HUSSAIN PATH,BYELANE9,RUPKONWAR PATH,HOUSE NO 1000
Kamrup
ASSAM
781032
India |
| Phone |
8752861728 |
| Fax |
|
| Email |
mrigakhijmc2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY,GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI,ASSAM,PIN-781032 |
|
|
Primary Sponsor
|
| Name |
Dr Mrigakhi Bordoloi |
| Address |
Dept of Anaesthesiology and critical care ,Gauhati Medical College and Hospital ,Bhangagarh,Guwahati,Assam,Kamrup,Assam,pin 781032,India |
| Type of Sponsor |
Other [self] |
|
|
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 MRIGAKHI BORDOLOI |
GAUHATI MEDICAL COLLEGE AND HOSPITAL |
SURGERY MAJOR OT WAITING ROOM GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI,ASSAM
Kamrup
ASSAM |
08752861728
mrigakhijmc2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,GAUHATI MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
midazolam |
group A patients will be treated with IV midazolam PREMEDICATION @ 0.035mg/kg and anxiety and sedation levels along with responsiveness score of Modified Obsevers Assessment of alertness/sedation scale will be assessed. |
| Comparator Agent |
Normal Saline |
Group B will be treated with normal saline and anxiety and sedation levels along with responsivess scores of Modified Observers assessment of alertness/sedation scale will be assessed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 patients undergoing elective surgery under GA
2 asa 1 and 2
3 patients in whom difficult mask ventilation anticipated
a. edentulous
b.bearded
c.BMI more than equal to 26 to less than equal to 35
d.history of snoring
|
|
| ExclusionCriteria |
| Details |
1.Patients with previous anaesthetic record of difficult intubation
2.Previous history of cervical spine disease or cervical spine surgery
3.History of chronic usage of opiods,benzodiazepines,antipsychotics
4.Pregnancy
5.Presence of muscular weakness or Neuromuscular disorders
6.Diagnosed case of Obstructive sleep apnea
7.Patients allergic to midazolam
8.Patients planned for awake intubation
9.Patients with increased risk of aspiration of gastric contents. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Midazolam premedication facilitates ease on ventilation by facemask following induction of anaesthesia in patients with anticipated difficult bag and mask ventilation |
outcome will be assessed at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare sedation scores between 2 groups.
To compare any other relevant findings |
Anxiety and sedation levels measured before and 3 minutes after treatment of midazolam premedication using numerical rating scale and responsiveness scores of modified observers assessment of alertness/sedation scale |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
30/03/2023 |
| 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="5"
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
|
Premedication with midazolam is used to allay anxiety and thereby facilitate mask ventilation during induction of General Anaesthesia as anxiolytic effect of midazolam reduces basal tone in airway muscles and improve mask ventilation during anaesthetic induction.. Hence the study is conducted to evaluate the effect of midazolam premedication on mask ventilation in patients with anticipated difficult bag and mask ventilation |