| CTRI Number |
CTRI/2020/09/028068 [Registered on: 28/09/2020] Trial Registered Prospectively |
| Last Modified On: |
22/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Anaesthesia effects and changes to be done in patients with Tuberculosis affecting the brain |
|
Scientific Title of Study
|
Anaesthesia implications in patients with Tuberculosis of Central Nervous System |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dity Nissi Roja |
| Designation |
Junior Resident |
| Affiliation |
Lokmanya Tilak Municipal Medical College and General Hospital |
| Address |
No.4,Timo Cottage, A.R street, Kamaraj Nagar, Pondicherry Room No. 533, New OPD building, Lokamnya Tilak Municipal Medical College, Sion West, Mumbai, Maharashtra Pondicherry PONDICHERRY 605006 India |
| Phone |
8754770729 |
| Fax |
|
| Email |
nissiroja@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Hemangi Karnik |
| Designation |
Professor |
| Affiliation |
Lokmanya Tilak Municipal Medical college and General Hospital |
| Address |
N-2/3 Narayan Pujari Nagar, K.A. Gafar Khan road, Worli, Mumbai- 400018 Department of Anaesthesia, Lokmanya Tilak Municipal Medical college and General Hospital, Sion, Mumbai-400022 Mumbai MAHARASHTRA 400018 India |
| Phone |
9324501900 |
| Fax |
|
| Email |
dr_hemangi@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Hemangi Karnik |
| Designation |
Professor |
| Affiliation |
Lokmanya Tilak Municipal Medical college and General Hospital |
| Address |
N-2/3 Narayan Pujari Nagar, K.A. Gafar Khan road, Worli, Mumbai- 400018 Department of Anaesthesia, Lokmanya Tilak Municipal Medical college and General Hospital, Sion, Mumbai-400022 Mumbai MAHARASHTRA 400018 India |
| Phone |
9324501900 |
| Fax |
|
| Email |
dr_hemangi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical College and General Hospital |
|
|
Primary Sponsor
|
| Name |
Lokmanya Tilak Municipal Medical College and General Hospital |
| Address |
Lokmanya Tilak Municipal Medical College and General Hospital, Sion West, Mumbai, Maharashtra |
| Type of Sponsor |
Government medical college |
|
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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 |
| Dity Nissi Roja |
Lokmanya Tilak Municipal Medical College and General Hospital |
Department of Anaesthesiology,
Room nos. 423-432,
4th Floor,College Building
LTMMC,Sion, Mumbai, Maharashtra 400022 Mumbai MAHARASHTRA |
8754770729
nissiroja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A179||Tuberculosis of nervous system, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.All age groups.
2.Both genders
3.Confirmed or provisionally diagnosed CNS tuberculosis cases based on clinical and radiological findings and undergoing surgeries under anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Patients having congenital cardiac abnormalities
2.Patients suffering from major pulmonary or renal problems due to other causes
3.Patient/ patient’s relatives not willing to participate in the study.
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate perioperative concerns in CNS tuberculosis patients and assess how it affects anaesthetic techniques and interventions. |
1. To note the pre-operative concerns in patients with cns tb like electrolyte balance,nutrition,dehydration.
2. To assess alterations in anaesthesia techniques, drug choices and dosages due to CNS Tuberculosis
3.to note the intra-operative problems like hemodynamic change, hypoxia, respiratory depression etc
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To also assess other associated problems during the management of CNS TB patients undergoing surgery |
1.To note the postoperative problems like need of ventilatory support
2.To note the risks faced by anaesthesiologists and other health care workers if any |
|
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Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/10/2020 |
| 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="0" Months="8" 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)?
|
|
Brief Summary
|
Tuberculosis has resurged and remained a major worldwide health problem. Approximately 5–10% of all patients with tuberculosis have CNS involvement. CNS tuberculosis usually results from haematogenous spread. CNS tuberculosis manifests itself primarily as tuberculous meningitis (TBM) and less commonly as tubercular encephalitis, intracranial tuberculoma, or a tuberculous brain abscess (3). PURPOSE OF TRIAL: Patients with CNS tuberculosis may also have several general or systemic problems like malnourishment, respiratory compromise due to either tuberculosis or secondary to unconsciousness, electrolyte abnormalities etc. All these pose additional concerns while providing anaesthesia when, such patients present for surgery. Therefore, the present study is undertaken to evaluate anaesthesia concerns and their management during surgery in patients with CNS tuberculosis. METHODOLOGY: After IEC-HR Permission, patients provisionally diagnosed or confirmed as CNS tuberculosis satisfying all inclusion and exclusion criteria will be included into the study. All patients/patients relatives will be explained about the study and a written valid informed consent for their willingness to participate in the study will be taken. All the basic information about the patient and preoperative concerns will be noted from the patient’s history and case sheets. The type and severity of CNS tuberculosis will be noted. Preoperative evaluation will be carried out and all general and/or systemic abnormalities will be noted. Patient will be managed intra-operatively as per concerned qualified anesthesiologist’s discretion. Any alterations in anaesthesia protocol- in technique, drug choices or drug dosages will be noted along with the reasons. Any problems faced during the entire perioperative period (till 24 hours post-anaesthesia) will be noted in the case record form along with the management. This a present observational study. For the current study following parameters will be noted: 1. Type of Tuberculosis 2. Medication history 3. General examination findings 4. CT scan findings 5. Type of anaesthesia given 6. Anaesthesia Implications: · Related with CNS Tuberculosis · Airway obstruction · Increased intracranial pressure · Active infection · Fever · Leukocytosis · Low serum proteins · Related with complications of disease · Pulmonary aspiration · Electrolyte imbalance · Arrhythmia · Bed sores · Related with concomitant disease · HIV · Related with therapy · Liver dysfunction 7. Anaesthesia alterations 8. Anaesthesia problems 9. Perioperative complications
DATA ANALYSIS: Statistical analysis will be performed using commercially available statistical software (SPSS 19.0; SPSS, Inc.). Chi-square tests will be used for assessing the association between study variables and outcome. Multivariate analysis with binary logistic regression analysis will be performed to look for the predictors of long-term outcome; p < 0.05 will be considered to be significant.
WORK DONE SO FAR: Many studies have been done in past, which have found the complications related with CNS tuberculosis and its treatment. Some studies have been done about anaesthesia implications in tuberculosis. But, the anaesthesia concerns in CNS tuberculosis patients and their management has not been studied much, which is being done in our study. |