| 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 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,ABVIMS and Dr.RML Hospital |
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: O||Medical and Surgical, |
|
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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. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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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. |
|
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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. |
|
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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 |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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 converter. The 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. HYPOTHESIS : Bispectral index values with sensor placement on the nasal dorsum site are comparable to values from standard frontal-temporal site for measuring depth of anesthesia. |