| CTRI Number |
CTRI/2024/05/067245 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of two inhalational anaesthetic agent for patients undergoing surgery in general anaesthesia. |
|
Scientific Title of Study
|
A randomized controlled study of haemodynamic parameters, recovery characteristics of desflurane and sevoflurane in adult patients receiving BIS guided 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 |
Varun B.R. |
| Designation |
Junior resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College |
| Address |
Department of Anaesthesiology, Lala Lajpat Rai Memorial Medical college, Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9743864594 |
| Fax |
|
| Email |
varunbr1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kumar Manik |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical college |
| Address |
Department of Anaesthesiology, Lala Lajpat Rai Memorial Medical College, Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9634857368 |
| Fax |
|
| Email |
dr.yogeshkmanik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Kumar Manik |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical college |
| Address |
Department of Anaesthesiology, Lala Lajpat Rai Memorial Medical College, Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9634857368 |
| Fax |
|
| Email |
dr.yogeshkmanik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Lala Lajpat Rai Memorial medical collge, Meerut |
|
|
Primary Sponsor
|
| Name |
Dr Varun B R |
| Address |
Department of Anaesthesiology, Lala Lajpat Rai Memorial medical college, Meerut |
| Type of Sponsor |
Other [Self] |
|
|
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 VARUN B R |
SVBP HOSPITAL |
G-02,Department of Anaesthesia, LLRM Medical College, MEERUT
Meerut
UTTAR PRADESH |
9743864594
varunbr1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
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 |
Desflurane |
The dose of the desflurane will be Bispectral index guided and the BIS score will be maintained between 60 to 40, used during maintenance of anaesthesia, route of administration is inhalational, duration of administration is after induction of anaesthesia till last skin suture. |
| Comparator Agent |
SEVOFLURANE |
The dose of the sevoflurane will be Bispectral index guided and the BIS score will be maintained between 60 to 40, used during maintenance of anaesthesia, route of administration is inhalational, duration of administration is after induction of anaesthesia till last skin suture. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade I and grade II Patients
2.Age- 18 to 65 years of either sex
3.Patients undergoing elective surgeries under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal,
2.Pregnancy,
3.significant cardiopulmonary diseases, hepatic and renal dysfunction,
4.chronic alcohol or narcotic drug abuse,
5.Known allergy or hypersensitivity to study drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Time for early recovery characteristics.
2.Time for intermediate recovery characteristics.
|
1.from the time of discontinuation of anaesthesia
2.5min, 10min, 15min in post anaesthesia recovery room |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Haemodynamic changes if any viz. Heart Rate, Mean Arterial Pressure, Systolic Blood Pressure, Diastolic Blood Pressure.
|
1. baseline,2min,3min,4min,5min,10min,15min,20min,30min,40min,50min,60min |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM:- The aim of this study is to compare and evaluate the intraoperative haemodynamic changes and recovery characteristics of desflurane and sevoflurane after Bispectral index(BIS) guided general anaesthesia. OBJECTIVES 1. Haemodynamic changes if any viz. Heart Rate, Mean Arterial Pressure, Systolic Blood Pressure, Diastolic Blood Pressure. 2. Time for early recovery characteristics. 3. Time for intermediate recovery characteristics. |