| CTRI Number |
CTRI/2025/07/090507 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare changes in blood glucose levels in patients undergoing infraumbilical surgeries under spinal versus general anaesthesia |
|
Scientific Title of Study
|
Study to compare changes in blood glucose levels in patients undergoing infraumbilical surgeries under spinal versus general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANTHOSH M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Mandya Institute of Medical Sciences, Mandya
Mandya 571401
Mandya
KARNATAKA
571401
India |
| Phone |
9886811263 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SANTHOSH M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Mandya Institute of Medical Sciences
Mandya 571401
Mandya
KARNATAKA
571401
India |
| Phone |
9886811263 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SANTHOSH M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Mandya Institute of Medical Sciences
Mandya 571401
Mandya
KARNATAKA
571401
India |
| Phone |
9886811263 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Major OT complex, Department of Anaesthesiology, Mandya Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Varun N S |
| Address |
Department of Anesthesiology, Mandya Institute of Medical Sciences, Mandya 571401 |
| Type of Sponsor |
Other [Post Graduate student] |
|
|
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 N S |
Mandya Institute of Medical Sciences |
Department of Anaesthesiology, MIMS, Mandya
Mandya
KARNATAKA |
09742223285
varunns2104@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Posted for infraumbilical surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patients |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative capillary blood glucose levels |
3 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
22/07/2025 |
| 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="0"
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
|
After
obtaining ethical committee clearance, patients aged 18-60 years belonging to
ASA class I and II undergoing elective infraumbilical surgeries under either
spinal anaesthesia or general anaesthesia fulfilling the pre determined
inclusion and exclusion criteria will be
enrolled in the study. The data shall be recorded using a semi structured
proforma which contains 2 parts.
1. The first part contains the details regarding
socio-demographic characteristics like name, age, sex and baseline values of
Pulse rate, Systolic and Diastolic Blood
pressure, Mean Arterial Pressure and SpO2 will be recorded.
2. The second part contains the details of time of induction
of spinal anaesthesia/general anaesthesia and the capillary blood glucose
levels just before induction.
GA group:
Patients undergoing infraumbilical surgeries under general anaesthesia as
follows: pre-oxygenation with 100% oxygen, induction with 2mg/kg of propofol, 2mcg/kg
of Fentanyl, and 2mg/kg vecuronium for tracheal intubation, maintaining
anaesthesia with oxygen, nitrous oxide, sevoflurane, and vecuronium. At the end
of the surgery, patients will be reversed with glycopyrolate and neostigmine followed
by tracheal extubation.
SA group: Patients undergoing
infraumbilical surgeries under spinal anaesthesia receiving 0.5% heavy bupivacaine
15mg in L3-L4 interspace using 25G Quincke’s needle and in whom sensory block
was achieved to T6 dermatomal level.
Patients will be administered with adequate
intravenous crystalloid fluids like normal saline as a part of routine intraoperative
management.
Capillary blood glucose
levels (CBG) will be noted four times through out the perioperative period.
Time 1 (T1): preoperatively
5 mins before induction of anaesthesia as a baseline value
Time 2 (T2):
intraoperatively 30 mins after induction of anaesthesia.
Time 3 (T3): immediately at the end of
surgery in both the groups.
Time 4 (T4): postoperatively 60 mins after
the end of surgery in the recovery room. During each time sample taking, the
tips of fingers of the non dominant hand were disinfected with an alcohol swab
before pricking with a lancet to measure capillary blood glucose levels
|