| CTRI Number |
CTRI/2025/05/087640 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized control trial comparing recovery profile of patients posted for tympanoplasty under total intravenous anaesthesia with qCON and BIS guided depth of anaesthesia monitoring systems |
|
Scientific Title of Study
|
A randomized control trial comparing recovery profile of patients posted for tympanoplasty under total intravenous anaesthesia with qCON and BIS guided depth of anaesthesia monitoring systems |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhant Sugandhi |
| Designation |
Post Graduate Student |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
Dept. of Anaesthesiology, Bharati Hospital and Research Centre
Pune
MAHARASHTRA
411043
India |
| Phone |
8527755733 |
| Fax |
|
| Email |
sidsang1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhay Sancheti |
| Designation |
Professor |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
Dept. of Anaesthesiology, Bharati Hospital and Research Centre
Pune
MAHARASHTRA
411043
India |
| Phone |
9371107686 |
| Fax |
|
| Email |
drabhaysancheti19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddhant Sugandhi |
| Designation |
Post Graduate Student |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
Dept. of Anaesthesiology, Bharati Hospital and Research Centre
Pune
MAHARASHTRA
411043
India |
| Phone |
8527755733 |
| Fax |
|
| Email |
sidsang1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and Research Centre, Pune-Satara Road, Pune-411043, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital and Research Centre Pune |
| Address |
Bharati Hospital and Research Centre, Pune-Satara Road, Pune-411043, Maharashtra, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DR SIDDHANT SUGANDHI |
BHARATI VIDYAPEETH MEDICAL COLLEGE AND HOSPITAL |
Department of Anaesthesia, 3rd Floor, Beside OT Complex, Bharati Hospital and Research Centre, Pune-Satara Road, Dhankawadi, Pune -411043, Maharashtra
Pune
MAHARASHTRA |
8527755733
sidsang1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHARATI VIDYAPEETH MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H958||Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BIS Monitor |
Bispectral Index (BIS Index) and qCON are numerical processed, clinically confirmed EEG parameters obtained by combining several advanced technologies which are combined to optimize the correlation between EEG and clinical effects of Anaesthesia. They are monitors which will be connected to patients using electrodes placed on patients head from the beginning of anaesthesia till the patient becomes conscious and oriented. |
| Comparator Agent |
qCON Monitor |
Bispectral Index (BIS Index) and qCON are numerical processed, clinically confirmed EEG parameters obtained by combining several advanced technologies which are combined to optimize the correlation between EEG and clinical effects of Anaesthesia. They are monitors which will be connected to patients using electrodes placed on patients head from the beginning of anaesthesia till the patient becomes conscious and oriented. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All elective tympanoplasty surgeries under Total Intravenous Anaesthesia lasting between 1.5 to 3 hours
2.Patient categorized under American Society of Anaethesiology Categories I, II and III. |
|
| ExclusionCriteria |
| Details |
1. Patients categorized under American Society of Anaethesiology Categories IV and above.
2. Patients unwilling to sign the written consent.
3. Patients that require mechanical ventilation or do not have a patent airway. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare time for eye opening of patients posted for tympanoplasty under total intravenous anaesthesia with qCON and BIS guided depth of anaesthesia monitoring systems. |
After stopping of Infusions. Time at which primary outcome is achieved will be noted down |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| i. To compare the amount of Propofol required per hour between qCON & BIS guided depth of anaesthesia monitoring systems. |
After the stopping of infusions. Immediately after the surgery gets over |
| ii. To evaluate the Ramsay Sedation Score- 0, 15 & 30 mins after the end of infusion & compare them for qCON & BIS guided depth of anaesthesia monitoring systems |
0, 15 & 30 mins after the end of infusion |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
26/05/2025 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sidsang1@gmail.com].
- For how long will this data be available start date provided 01-06-2026 and end date provided 01-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
•
Study will be conducted after taking approval
from Central Scientific Review committee, Institutional Ethical committee and
CTRI registration.
•
Patients undergoing tympanoplasty will be screened for the
study.
•
All the eligible patients as per the inclusion and exclusion
criteria, will be explained about the nature, purpose and
methodology of the study with the help of a participant information sheet and
informed consent will be taken.
•
It will be explained to the patient
that they will be blinded as to which depth of anaesthesia monitor will be applied
intra-operatively in their procedure.
• The
patient will then be randomly allocated by computer-based program to one of the
two groups -
a.
GROUP A –Patients
in which Depth will be monitored by qCON
b. GROUP B –Patients in which Depth will be monitored by
BIS.
• Patients’
details will be filled according to proforma.
•
All patients will be kept nil per
oral 6 hours prior to surgery.
•
Monitors will be attached, and IV
line secured with 20 G cannula. Vitals and other parameters to be recorded.
•
Anaesthesia plan will be Total
Intravenous Anaesthesia with supplemental oxygen using nasal prongs.
•
Inj. Midazolam 0.05mg/kg for
premedication, Inj. Remifentanil 0.5 mcg/kg/min infusion and Inj. Propofol
2mg/kg for induction. Maintenance will be done with Inj. Propofol 50mcg/kg/min
infusion.
•
The dose of Propofol infusion will be
adjusted intraoperatively every 10 mins guided by BIS/qCON systems, maintaining
a score of 40-60. For every increase/decrease in score by 10, propofol infusion
will be changed by 10mcg/kg/min respectively. Number of patient movements and
Propofol adjustments will be noted.
•
Infusions will be stopped at the end
of the surgery. Then, the time taken for eye-opening of the patient, from the
end of infusions will be noted and the amount of Inj. Propofol used per hour
during the surgery will be calculated.
•
Once the patient is shifted in Post Anesthesia
Care Unit, sedation will be assessed using Ramsay Sedation Scale as follows at
0, 15 and 30 mins post eye opening. |