| CTRI Number |
CTRI/2021/12/038579 [Registered on: 10/12/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
What is the effect of inhalational anaesthetic agents on blood glucose levels in non diabetic patients? |
|
Scientific Title of Study
|
A comparative study of the effect of inhalational anaesthetic agents: Sevoflurane, Isoflurane and Desflurane on the blood glucose levels in non diabetic patients under 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 Chandini K |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
A block OT complex, 4 th floor, Department of Anesthesiology,AIIMS Campus, GE road, Tatibandh, Raipur, Chhattisgarh-492099
AIIMS Campus, GE road, Tatibandh, Raipur, Chhattisgarh-492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9361419889 |
| Fax |
|
| Email |
chandiniamar01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandkishore Agrawal |
| Designation |
Professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Anaesthesiology,
AIIMS Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9373103294 |
| Fax |
|
| Email |
nkagrawal1963@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandkishore Agrawal |
| Designation |
Professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Anaesthesiology,
AIIMS Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9373103294 |
| Fax |
|
| Email |
nkagrawal1963@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Raipur |
| Address |
AIIMS Campus, GE road, Tatibandh, Raipur, Chhattisgarh-492099 |
| 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 Chandini K |
All India Institute of Medical Sciences, Raipur |
A Block OT complex,4th floor, Department of Anesthesiology,AIIMS Campus, GE road, Tatibandh, Raipur, Chhattisgarh -492099
Raipur
CHHATTISGARH |
9361419889
chandiniamar01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- AIIMS RAIPUR |
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 |
Inhalational anesthetic agent used in the induction and maintenance of general anesthesia during the surgical procedure. Minimum alveolar concentration of 1.0 will be achieved initially and later titrated according to the hemodynamic stability of the patient. Finally at the end of the surgery, the inhalational agent will be turned off and blood glucose level will be measured after achieving minimum alveolar concentration 0.The total duration is from the time of induction to the end of surgery. |
| Intervention |
Isoflurane |
Inhalational anesthetic agent used in the induction and maintenance of general anesthesia during the surgical procedure. Minimum alveolar concentration of 1.0 will be achieved initially and later titrated according to the hemodynamic stability of the patient. Finally at the end of the surgery, the inhalational agent will be turned off and blood glucose level will be measured after achieving minimum alveolar concentration 0. The total duration is from the time of induction to the end of surgery. |
| Comparator Agent |
Sevoflurane |
Inhalational anesthetic agent used in the induction and maintenance of general anesthesia during the surgical procedure. Minimum alveolar concentration of 1.0 will be achieved initially and later titrated according to the hemodynamic stability of the patient. Finally at the end of the surgery, the inhalational agent will be turned off and blood glucose level will be measured after achieving minimum alveolar concentration 0. The total duration is from the time of induction to the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Age: 18 to 60 years
2. Gender: both male and female
3. ASA grade: I or II
4. Duration of surgery : Minimum 2 hours
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Diabetic patient/ hyperglycemic patient
3. Hypertensive patient
4. Patient on drugs causing hypo or hyperglycemia like steroids, OHA, etc.
5. Contraindication to inhalational anesthetic agents- Uncontrolled hypotension, previous history of malignant hyperthermia, increased intracranial pressure
6. Patient requiring Rapid sequence intubation
7. Patients with pancreatic disorders such as chronic pancreatitis, carcinoma pancreas, etc
8. Patients with Catecholamine secreting tumors
9. Patients undergoing pancreatic surgeries
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood glucose levels |
baseline, preinduction, at MAC 1, at 15 minute intervals intraoperatively, AFter achieving MAC 0, Postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Best inhalational agent with respect to glycemic control |
Blood glucose at baseline, preinduction, at MAC 1, at 15 minute intervals intraoperatively, AFter achieving MAC 0, Postoperative |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2021 |
| Date of Study Completion (India) |
23/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted to observe the effects of Sevoflurane, Isoflurane and Desflurane
on blood glucose levels in non-diabetic patients. Very few research articles are available on
this study and hence the results obtained from this study will be useful in choosing the
appropriate inhalational agent in patients and can help in achieving better glycemic control.
The results obtained will also be a useful research tool for further studies in diabetic patients. |