| CTRI Number |
CTRI/2025/09/094746 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of checking blood sugar level between patients with diabetes under control and without diabetes posted for gall bladder removal operation under general anesthesia |
|
Scientific Title of Study
|
A Prospective, Randomised, Parallel group study of Peri-operative blood sugar level between non-diabetic and controlled diabetic patients posted for laproscopic cholecystectomy under 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 |
Manisha Agarwal |
| Designation |
Post graduate trainee MD anesthesiology |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Working womens hostel, near bhabhaghuree awas , opposite midnapore collegiate school ground , midnapore
c/o shree balajee medical , main road gamharia , jamshedpur ,jharkhand
Medinipur
WEST BENGAL
721101
India |
| Phone |
7991175721 |
| Fax |
|
| Email |
agarwalmanirims0807@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Chatterjee |
| Designation |
Professor and Head of the Department of Anesthesiology |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anesthesiology, Midnapore Medical College and Hospital
Vidyasagar road, Paschim Midnapore
Medinipur
WEST BENGAL
721101
India |
| Phone |
9830234881 |
| Fax |
|
| Email |
sumanc24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar Mandi |
| Designation |
Assistant professor Department of Anesthesiology |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anesthesiology, Midnapore Medical College and Hospital
Vidyasagar road, Paschim Midnapore
Medinipur
WEST BENGAL
721101
India |
| Phone |
8697633923 |
| Fax |
|
| Email |
mandiarunkr87@gmail.com |
|
|
Source of Monetary or Material Support
|
| OFFICE OF PRINCIPAL MIDNAPORE MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Midnapore medical college and hospital |
| Address |
The office of principal, Midnapore medical college and hospital , vidyasagar road , midnapore , 721101 |
| 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 |
| Manisha Agarwal |
Midnapore Medical College and Hospital |
Surgery OT Complex, Post operative anesthesia care unit, surgery ward, department of general surgery, Midnapore medical college and hospital
Medinipur
WEST BENGAL |
07991175721
agarwalmanirims0807@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: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Perioperative blood sugar level in diabetic patients |
• Blood sugar level estimation will be done immediately after intubation and 1 hour after induction in the intra-operative period. Hemodynamic changes will also be noted in the intra-operative period immediately after every 15 min after intubation , in terms of incidence of hypotensive and hypertensive episodes by comparing the current non -invasive mean arterial pressure with the baseline MAP |
| Comparator Agent |
perioperative blood sugar level in non diabetic patients |
• Blood sugar level estimation will be done immediately after intubation and 1 hour after induction in the intra-operative period. Hemodynamic changes will also be noted in the intra-operative period immediately after every 15 min after intubation , in terms of incidence of hypotensive and hypertensive episodes by comparing the current non -invasive mean arterial pressure with the baseline MAP |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade 1 non-diabetic patients with FBS less than 126, PPBS less than 200, HbA1c less than 6.5 percent
2. ASA grade 2 controlled diabetic patients on 1 or more OHA with FBS less than 126, PPBS less than 200, HbA1c less than 6.5 percent
3. BMI 18.5 to 24.9
4. Patients under oral hypoglycemic agents
5. Undergoing elective laparoscopic cholecystectomy under general anesthesia for less than 90 minutes |
|
| ExclusionCriteria |
| Details |
1. patients under insulin therapy.
2. patients with uncontrolled diabetes
3. patients with signs of microvascular and macrovascular complications.
4.Emergency surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of blood sugar levels among non-diabetic patients and controlled diabetic patients posted for laparoscopic cholecystectomy under general anaesthesia.
|
Before induction Just after intubation 1hr after induction 1 hrs after extubation 2 hrs after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Both the non-diabetic & controlled diabetic groups are followed up:
1.To monitor & compare hemodynamic changes in terms of intra-operative incidence of hypertensive episode (i.e. 20% increase in baseline MAP), hypotensive episode (i.e. 20% decrease in baseline MAP) & significant ST changes if any.
2. To monitor & compare incidence of postoperative nausea & vomiting for a time span of 24 hours.
3.To monitor & compare extent of wound healing till postoperative day 3.
|
before induction,after intubation,15min,30min,45min,1 hr,90min,1hr after extubation,pod1,pod2,pod3 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Proposed study will compare the change in the blood glucose levels of non diabetic and controlled diabetic patients undergoing laparoscopic cholecystectomy under general anesthesia . The metabolic changes patient undergoes during surgery is proportional to severity of surgical stress and trauma . Hence the monitoring of the perioperative blood sugar is crucial in managing patients undergoing general anesthesia . Along with blood sugar other parameters like - 1. Intra operative hemodynamic changes in terms of incidence of hypertensive and hypotensive episodes 2. Intra operative changes in heart rate, ST segment elevation up to 2 mm 3. Wound healing up to post op 3 days In this study currently we do not have clear idea regarding the outcome , which can only be confirmed after completion of the study |