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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 
 
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 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A179||Tuberculosis of nervous system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
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 
 
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.

 

 

 


 
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