| CTRI Number |
CTRI/2022/01/039622 [Registered on: 21/01/2022] Trial Registered Prospectively |
| Last Modified On: |
09/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Anesthesia management of covid-19 associated ROC mucormycosis |
|
Scientific Title of Study
|
Perioperative anesthetic management of covid-19 associated rhinoorbitocerebral mucormycosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwini Yadavrao Sontakke |
| Designation |
Senior Registrar |
| Affiliation |
Government Medical College, Nanded |
| Address |
Department of Anaesthesia, Dr. Shankarrao Chavan Government Medical College and Hospital Vishnupuri Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
8087330897 |
| Fax |
|
| Email |
drsontakkeashwiniy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishnavi Kulkarni |
| Designation |
Professor and Head of the department |
| Affiliation |
Dr. Shankarrao Chavan Government Medical College, Nanded |
| Address |
Department of Anaesthesia, Dr. Shankarrao Chavan Government Medical College and Hospital Vishnupuri Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
8087330897 |
| Fax |
|
| Email |
anaesthesiascgmcnanded@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Yadavrao Sontakke |
| Designation |
Senior Registrar |
| Affiliation |
Government Medical College, Nanded |
| Address |
Department of Anaesthesia, Dr. Shankarrao Chavan Government Medical College and Hospital Vishnupuri Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
8087330897 |
| Fax |
|
| Email |
drsontakkeashwiniy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Shankarrao Chavan Government Medical College Nanded 431605 |
|
|
Primary Sponsor
|
| Name |
Ashwini Yadavrao Sontakke |
| Address |
Deparment of Anaesthesia
Dr. Shankarrao Chavan Government Medical College Nanded 431601 |
| 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 Ashwini Yadavrao Sontakke |
Dr. Shankarrao Chavan Government Medical College and Hospital Vishnupuri Nanded |
Room no. 87 Department of Anaesthesia, Dr. Shankarrao Chavan Government Medical College and Hospital Vishnupuri Nanded
Nanded
MAHARASHTRA |
8087330897
drsontakkeashwiniy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Human Resources |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients posted for emergency or elective surgical resection of rhiniorbitocerebral mucormycosis under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Lack of patients consent
coagulopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Study the outcome of patients in following parameters
Requirement of inotropic support, ventilator support, ICU stay, total duration of hospitalization, co-morbid condition affecting the outcome
2.Mortality rate and average mortality time |
1.Before Surgery
2.Intraoperative
3.Immediate postoperative
4.Till discharge / Death
5.30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Early debidement of disease and outcome of patients.
5.co-relation between predisposing factors and outcome of patients
|
till dischage |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/01/2022 |
| Date of Study Completion (India) |
09/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After approval from the ethics committee and written informed consent, patients posted for emergency surgical resection of rhinoorbitocerebral mucormycosis under general anaesthesia satisfying inclusion and exclusion criteria for the study will be observed. intaoperative monitoring will include 3 lead electrocardiogram, heart rate, peripheral oxygen saturation, end tidal carbon dioxide concentration, non invasive blood pressure monitoring. patients, that will not have any intaoperative complications will be extubated in operative room before transfer to post-anaesthesia care unit or ward. however, patients undergoing extensive surgical resection, hemodynamic unstability are transferred to post anaesthesia care unit with endotracheal tube or tracheostomy tube in situ.
Parameters to be noted : age gender BMI systemic Illness duration of Diabetes COVID-19 status vaccination duration between COVID-19 and rhinoorbitocerebral symptoms clinical staging of mucormycosis duration between symptoms and surgery Amphotericin -b days pre-operative condition of patient RT-PCR ASA-PS grade airway examination anticoagulation/bedridden steroids status RS CVS spo2 RBS Investigations intra-operative- pulse/NIBP/ intubation Ax maintenance surgery performed anaesthesia duration surgery duration complications post-anaesthesia care unit ventilatory support/inotropic support total days of hospitalisation total number of debridement discharged/died 30 days outcome |