| CTRI Number |
CTRI/2019/05/019471 [Registered on: 31/05/2019] Trial Registered Prospectively |
| Last Modified On: |
29/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study of monitoring depth of anaesthesia (bispectral index and Minimum Alveolar Concentration)between two inhalational general anaesthesia agents |
|
Scientific Title of Study
|
Single blind randomised comparative study of bispectral index associated Minimum Alveolar Concentration values between sevoflurane and desflurane inhalational 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 |
Dr Minal Harde |
| Designation |
Associate Professor |
| Affiliation |
Department Of Anaesthesiology, Topiwala National Medical College & B.Y L. Nair Ch. Hospital, Mumbai |
| Address |
Nair Hospital, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
440011
India |
| Phone |
022-23027137 |
| Fax |
|
| Email |
minalharde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minal Harde |
| Designation |
Associate Professor |
| Affiliation |
Department Of Anaesthesiology, Topiwala National Medical College & B.Y L. Nair Ch. Hospital, Mumbai |
| Address |
Nair Hospital, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
440011
India |
| Phone |
022-23027137 |
| Fax |
|
| Email |
minalharde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipali Biradar |
| Designation |
First year Resident |
| Affiliation |
Department Of Anaesthesiology, Topiwala National Medical College & B.Y L. Nair Ch. Hospital, Mumbai |
| Address |
Nair Hospital, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
440011
India |
| Phone |
022-23027137 |
| Fax |
|
| Email |
db7588237652@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical Institute
Topiwala National Medical college, BYL Nair Ch Hospital Mumbai |
|
|
Primary Sponsor
|
| Name |
Topiwala national medical college and BYL Nair ch HospitalInstitue |
| Address |
Topiwala National Medical College & B.Y L. Nair Ch. Hospital, Mumbai Central, Mumbai-08 |
| Type of Sponsor |
Government medical college |
|
|
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 Minal Harde |
TNMC and BYL Nair Ch Hospital |
Operation Theatre, Topiwala National Medical College, BYL Nair Ch Hospital
Mumbai
Mumbai
MAHARASHTRA |
02223027137
minalharde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects(ECARP) T.N. Medical College and BYL Nair ch. hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bispectral index and minimum alveolar concentration both
are non invasive methods of monitoring depth of anaesthesia without any added risk.
Inhalational anaesthetic agents (sevoflurane and desflurane) will be admisnistered during standard balanced general anaesthesia in Indian population in tertiary
care teaching public hospital. |
All the elective
surgery patients will be assessed and investigated by attending anaesthesiologists
All patients who fit in the inclusion criteria will be included in study
after written, valid and informed consent. Standard balanced general anaesthesia with endotracheal intubation and controlled ventilation depending upon patients’ and surgical requirement will be administered. One of the inhalational anaesthetic agents(Sevoflurane or Desflurane) will be used. Once the patient achieves stable depth of anaesthesia with
target BIS value 40-60, patient will be maintained in the same depth by titrating the end
tidal concentration of inhalational agent. End tidal concentration and MAC value of
sevoflurane or desflurane will be noted. Study period is predetermined as the 1st 60 minutes after surgical incision as some
time is required to achieve steady state concentration and stable depth of anaesthesia. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2
Elective surgery |
|
| ExclusionCriteria |
| Details |
h/o head injury
k/c/o mental retardation
k/c/o parenchymal brain disease
h/o poisoning
drug addiction
pregnancy
Alzheimer’s disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare bispectral index associated MAC values between sevoflurane and
desflurane inhalational general anaesthesia for better understanding of changes in
MAC values. |
Intraoperative parameters (Hemodynamic parameters, BIS, MAC etc) will be noted after 15 minutes of induction for 60 minutes at every 5 minutes interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine Bispectral index associated Minimum Alveolar Concentration
values of Sevoflurane and Desflurane.
2. To compare Bispectral index associated Minimum Alveolar Concentration
values among Sevoflurane and Desflurane.
3. To compare demographic and vital parameters and end tidal concentration of
anaesthetic agents among Sevoflurane and Desflurane. |
Intraoperative parameters (Hemodynamic parameters, BIS, MAC etc) will be noted after 15 minutes of induction for 60 minutes at every 5 minutes interval |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/06/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All the patients who fit inclusion criteria will be randomly selected using computerised table to receive one of
inhalational agent (sevoflurane or desflurane) in combination with air in 50% oxygen for
maintenance of anaesthesia. Once the patient achieves stable depth of anaesthesia with
target BIS value 40-60, patient will be maintained in the same depth by titrating the end
tidal concentration of inhalational agent. End tidal concentration and MAC value of
sevoflurane or desflurane will be noted. The study period is predetermined as the 1st 60 minutes after surgical incision as some
time is required to achieve steady state concentration and stable depth of anaesthesia
which is usually after initial 15 minutes of induction. We will note pulse, blood pressure, SpO2,
ETCO2, BIS, inspired concentration of inhalational agent, end tidal concentration of inhalational agent and MAC values every 5 minutes
interval throughout 1 hr of study period.MAC readings will be taken at after initial 15
minutes of intubation till 60 minutes after surgical incision. Data will be analysed using appropriate statistical methods. |