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CTRI Number  CTRI/2022/12/048105 [Registered on: 14/12/2022] Trial Registered Prospectively
Last Modified On: 08/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   COMPARISON OF BISPECTRAL INDEX (BIS) VALUES BETWEEN FRONTAL AND NASAL SENSOR PLACEMENT DURING SURGERY 
Scientific Title of Study   COMPARISON OF BISPECTRAL INDEX (BIS) VALUES BETWEEN FRONTAL AND NASAL SENSOR PLACEMENT DURING SURGERY UNDER GENERAL ANAESTHESIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahul Harish Moral Bamon 
Designation  Post Graduate Resident 
Affiliation  Department of Anaesthesiology, ABVIMS and RML Hospital 
Address  Department of Anaesthesiology, ABVIMS and RML Hospital,Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi

Central
DELHI
110001
India 
Phone  7002574932  
Fax    
Email  rahulmoralbamon@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjeev Sharma 
Designation  Professor 
Affiliation  Department of Anaesthesiology, ABVIMS and RML Hospital 
Address  Department of Anaesthesiology, ABVIMS and RML Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi

Central
DELHI
110001
India 
Phone  9873768774  
Fax    
Email  drss21@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Rahul Harish Moral Bamon 
Designation  Post Graduate Resident 
Affiliation  Department of Anaesthesiology, ABVIMS and RML Hospital 
Address  Department of Anaesthesiology, ABVIMS and RML Hospital,Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi

Central
DELHI
110001
India 
Phone  7002574932  
Fax    
Email  rahulmoralbamon@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, ABVIMS and RML Hospital,Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi 
 
Primary Sponsor  
Name  Department of Anaesthesia ABVIMS and Dr RML Hospital 
Address  Atal Bihari Vajpayee Institute of Medical Sciences & Dr. Ram Manohar Lohia Hospital Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi 
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 
Rahul Harish Moral Bamon  ABVIMS and Dr.RML Hospital  Department of Anaesthesia,ABVIMS and Dr.RML Hospital,Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi
Central
DELHI 
7002574932

rahulmoralbamon@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,ABVIMS and Dr.RML Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bispectral index monitoring   Comparison of Bispectral index values obtained from frontal sensor placement and nasal sensor placement 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)Consenting age group of 18-80 years of either sex.
2)ASA grade I and II
3)Patients undergoing any surgery under general anesthesia. 
 
ExclusionCriteria 
Details  1)Contraindications for the placement of electrodes over the forehead and nasal dorsum (e.g., the boundary area being too close to the surgical site or having skin infections).
2)Patients taking psychiatric medication.
3)Those with prior history of neurosurgical intervention. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To monitor Bispectral index (BIS) values from the two different sites (forehead and the nasal bridge) of electrodes  Before the induction of anesthesia, at loss of the eyelash reflex, after intubation, after the first surgical incision, thereafter every 15 minutes during the intraoperative period, and at spontaneous eye opening upon emergence from anaesthesia. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor hemodynamic parameters (HR, SBP, DBP, MAP, SPO2) and EtCO2   Before the induction of anesthesia, at loss of the eyelash reflex, after intubation, after the first surgical incision, thereafter every 15 minutes during the intraoperative period, and at spontaneous eye opening upon emergence from anaesthesia. 
To assess intra-operative awareness using Brice questionnaire  At postoperative care unit and 24 hours after surgery. 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   17/12/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

BRIEF SUMMARY : The Bispectral index (BIS) monitor based on the indication “to monitor the state of the brain by data acquisition of electroencephalogram (EEG) signals in the intensive care unit, operating room and for clinical research". The BIS module is a non-invasive device which consists of a sensor, a digital signal converter, and a monitor. The sensor is a single simplified strip composed of 4 electrodes placed on the patient’s forehead to pick up the electrical signals from the cerebral cortex and transfer them to the digital signal converterThe BIS device translates EEG data gathered from forehead electrodes and facilitates us with a BIS data value ranging from 0 to 100. A BIS value of 0 denotes suppressed EEG activity, and a value of 100 indicates the fully awake state. BIS values ranging between 40 and 60 is the proposed target in which the patients have minimal risk of experiencing intraoperative awareness with recall during general anaesthesia. A light plane of anesthesia can result in the recall of incidents or conversations that occurred while under anesthesia. Overly deep plane of anesthesia can also result in respiratory depression requiring respiratory assistance postoperatively. Hence, monitoring the depth of anesthesia has become increasingly necessary and remains an active area of research. BIS-guided anaesthesia in comparison to clinical signs may diminish the risk of intraoperative awareness, reduce requirement of anesthetic drugs and improve early recovery period in people undergoing surgery under general anaesthesia. The placement of electrodes in the fronto-temporal region is considered to be the gold standard for BIS monitoring. However, in some surgery cases the surgical incision site may hinder the placement of the electrodes.

HYPOTHESISBispectral index values with sensor placement on the nasal dorsum site are comparable to values from standard frontal-temporal site for measuring depth of anesthesia.

 
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