| CTRI Number |
CTRI/2025/04/085880 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of how quickly patients wake up after stopping of sevoflurane anaesthesia when different amount of fresh gas flow (4l/min and 0.8l/min ) used during waking up phase , while the lower gas flow is used during maintenance phase of anaesthesia |
|
Scientific Title of Study
|
Comparison The Emergence Time After Discontinuation Of Sevoflurane With Fresg Gas Flo w 4L/min and 0.8L/min During Emergence While in Maintanence Phase The Fresh Gas Flow is kept at 0.8L/min |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Madhavi Chaudhari |
| Designation |
PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
PRAMUKH SWAMI MEDICAL COLLEGE,BHAIKAKA UNIVERSITY |
| Address |
Department of Anaesthesiology, H M Patel Centre for Medical Care and Education, Karamsad, Anand Gujarat Anand Gujarat 388325 India
Anand
GUJARAT
388325
India |
| Phone |
9427084963 |
| Fax |
|
| Email |
madhavic@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shelvi Patel |
| Designation |
Resident |
| Affiliation |
PRAMUKH SWAMI MEDICAL COLLEGE, BHAI KAKA UNIVERSITY |
| Address |
Department of Anaesthesiology, H M Patel Centre for Medical Care and Education, Karamsad, Anand, Gujarat
388325 India
Anand
GUJARAT
388325
India |
| Phone |
9033272205 |
| Fax |
|
| Email |
shelvipatel0@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHELVI PATEL |
| Designation |
RESIDENT |
| Affiliation |
PRAMUKH SWAMI MEDICAL COLLEGE, BHAI KAKA UNIVERSITY |
| Address |
Department of Anaesthesiology, H M Patel Centre for Medical Care and Education, Karamsad, Anand, Gujarat
388325 India
Anand
GUJARAT
388325
India |
| Phone |
9033272205 |
| Fax |
|
| Email |
shelvipatel0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Krishna Hospital , Karamsad, Anand, Gujarat
388325 India
|
|
|
Primary Sponsor
|
| Name |
SHREE KRISHNA HOSPITAL |
| Address |
Shree Krishna Hospital , Karamsad, Anand, Gujarat 388325 India |
| Type of Sponsor |
Private 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 Madhavi Chaudhari |
Pramukh Swami Medical College |
Department of Anesthesiology, Pramukh Swami Medical College
Anand
GUJARAT |
9427084963
madhavic@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sevoflurane |
FGF will be continued at 0.8L/min during emergence and sevoflurane will be discontinued 20 minutes prior to last skin stitch at the end of surgery and time of discontinuation till the patient’s spontaneous movement , eye opening and time of extubation will be noted .Dose according to MAC value of sevoflurane ( MAC value of sevoflurane ) , frequency- once , route of administration ; inhalation , total duration ; depends on the duration of surgery
|
| Intervention |
Sevoflurane |
FGF will be increased to 4L/min and sevoflurane will be discontinued at the last skin stitch at the end of surgery and time of discontinuation of sevoflurane , time of patient’s spontaneous movement , eye opening and time of extubation is noted . Dose according to MAC value of sevoflurane ( MAC value of sevoflurane ) , frequency- once , route of administration ; inhalation , total duration ; depends on the duration of surgery
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing surgery under General Anaesthesia with surgery hour more than 1 hour and using cuffed Endotracheal Tube. Patient with ASA status I, II and III. Patient weight between 30 to 80 kgs |
|
| ExclusionCriteria |
| Details |
1.Patients refusing in taking part in the study
2.Neurological surgeries
3.Post operative patient who remain intubated or require elective ventilation
4.Patient of acute alcohol intoxication
5.Patient of diabetic keto acidosis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective: Comparing the emergence time after discontinuation of sevoflurane with fresh gas flow of 4l/min and 0.8l/min during emergence while in maintenance phase the fresh gas flow is kept at 0.8l/min
|
0 minutes to 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare time of eye opening after discontinuation of sevoflurane in both the groups
2. To compare time of spontaneous movement after discontinuation of sevoflurane in both the groups
|
0 minutes to 20 minutes |
1. To compare time of eye opening after discontinuation of sevoflurane in both the groups
2. To compare time of spontaneous movement after discontinuation of sevoflurane in both the groups
|
0 minutes to 20 minutes |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 2 |
|
Date of First Enrollment (India)
|
08/05/2025 |
| 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="1"
Months="0"
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
|
After obtaining institutional ethics
committee’s approval and written informed consent patients undergoing surgeries
under general anaesthesia will be recruited in this study. Participants will be
allotted in to two groups through balanced randomization. A computer software
viz. WINPEPI will be used for the randomization. The treatment allocation will
be kept in a sealed opaque envelopes and they will be opened after written
informed consent of eligible participants. Preoperative assessment will be done
and written informed consent will be obtained from all the patients who fulfil
the inclusion criteria. Patients will be randomly assigned to any one of the
two groups.
Group H -
FGF will be increased to 4L/min and sevoflurane
will be discontinued at the last skin stitch
at the end of surgery and time of discontinuation of sevoflurane , time of patient’s spontaneous
movement , eye opening and time of extubation
is noted . Group S - FGF will be continued at 0.8L/min during
emergence and sevoflurane will be
discontinued 20 minutes prior to last
skin stitch at the end of surgery and
time of discontinuation till the patient’s spontaneous movement , eye opening
and time of extubation will be noted . Method of assessment: Variables
to be assessed after discontinuation of sevoflurane ·
Time
of eye opening(min) ·
Time of spontaneous movement (min) ·
Time of extubation (min) ·
End tidal concentration of sevoflurane at various time – 1)
At sevoflurane discontinuation 2)
At eye opening 3)
At spontaneous movement 4)
At extubation ·
Entropy
at various time- 1)
At
sevoflurane discontinuation 2)
At
eye opening 3)
At
spontaneous movement 4)
At
extubation
|