| CTRI Number |
CTRI/2021/09/036834 [Registered on: 24/09/2021] Trial Registered Prospectively |
| Last Modified On: |
01/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Desflurane and Isoflurane |
|
Scientific Title of Study
|
A RCT to compare the emergence response of patients undergoing general anesthesia with desfluane or isoflurane for elective ENT surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nazia Nazir |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical sciences |
| Address |
DEPARTMENT OF ANESTHESIA, FIRST FLOOR OT COMPLEX, GIMS, GREATER NOIDA
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
|
| Fax |
|
| Email |
nazunazir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nazia Nazir |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical sciences |
| Address |
DEPARTMENT OF ANESTHESIA, FIRST FLOOR OT COMPLEX, GIMS, GREATER NOIDA
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
|
| Fax |
|
| Email |
nazunazir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nazia Nazir |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical sciences |
| Address |
DEPARTMENT OF ANESTHESIA, FIRST FLOOR OT COMPLEX, GIMS, GREATER NOIDA
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
|
| Fax |
|
| Email |
nazunazir@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical sciences |
| Address |
GREATER NOIDA |
| 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 NAZIA NAZIR |
Operation Theatre, First Floor,, Department Of Anesthesia, GOVERNMENT INSTITUTE OF MEDCAL SCIENCES |
GREATER NOIDA
Gautam Buddha Nagar
UTTAR PRADESH |
9560102957
nazunazir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GIMS IEC-ICR/1224/INST./UP/2019 |
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 |
IN GROUP 1 , PATIENTS WILL BR GIVEN GENERAL ANESTHESIA WITH DESFLURANETILL THE END OF PROCEDURE THROUGH INHALATIONAL ROUTE IN A DOSE TO ACHIEVE MAC OF 1.2. |
| Comparator Agent |
ISOFLURANE |
IN GROUP 2, PATIENTS WILL BE GIVEN GENERAL ANESTHESIA WITH ISOFLURANE THE END OF PROCEDURE THROUGH INHALATIONAL ROUTE IN A DOSE TO ACHIEVE MAC OF 1.2 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ALL ASA I & II PATIENTS FOR ELECTIVE ENT SURGERIES UNDER GENERAL ANESTHESIA |
|
| ExclusionCriteria |
| Details |
ASA III & IV PATIENTS, EMERGENCY SURGERIES, PATIENTS WITH HEPATIC, RENAL, NEUROLOGICAL DISEASE, ALCOHOL & DRUG ABUSE, PREGNANCY. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EMERGENCE TIME AS NOTED BY TIME TO EYE OPENING |
FROM END OF SURGERY, 1, 2,3 ,4,5,6,7, 8, 9, 10 MIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TIME TO EXTUBATION
TIME AT WHICH PATIENT FOLLOWS MOTOR COMMANDS: PROTRUSION OF TONGUE, SUSTAINED HEAD LIFT 5s.
TIME OF ABILITY TO STATE NAME & ADDRESS.
EFFECT ON HEART RATE, MEAN ARTERIAL PRESSURE, END TIDAL CO2 & END TIDAL AGENT CONCENTRATION.
INTRAOPERATIVE OPIOID CONSUMPTION & RELAXANT CONSUMPTION.
TIME TO DISCHARGE FROM PACU
COST EFFECTIVENESS. |
BASELINE, 2 MIN, 4 MIN , 6 MIN, 8 MIN, 10 MIN, 12, 14,16, 18, 20 MIN, 30, 40 50, 60, 70 MIN |
|
|
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)
|
30/09/2021 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
60 ASA 1 & II PATIENTS SCHEDULED FOR ELECTIVE ENT SURGERIES WILL BE INCLUDED IN THE STUDY. PATIENTS WILL BE RANDOMLY ASSIGNED INTO 2 GROUPS. IN GROUP 1, PATIENTS WILL BE GIVEN GENERAL ANESTHESIA WITH DESFLURANE & IN GROUP 2, PATIENTS WILL BE GIVEN GENERAL ANESTHESIA WITH ISOFLURANE. PATIENTS WILL BE OBSERVED IN THE INTRAOPERATIVE & POST OPERATIVE PERIOD TO RECORD THE EMERGENCE RESPONSE OF PATIENTS. |