跳至主要内容
临床试验/CTRI/2020/09/028068
CTRI/2020/09/028068尚未招募不适用

Anaesthesia implications in patients with Tuberculosis of Central Nervous System

Lokmanya Tilak Municipal Medical College and General Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
To evaluate perioperative concerns in CNS tuberculosis patients and assess how it affects anaesthetic techniques and interventions.

研究概览

简要总结

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 relativeswill 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.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

To evaluate perioperative concerns in CNS tuberculosis patients and assess how it affects anaesthetic techniques and interventions.

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Government medical college

研究点 (1)

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