| CTRI Number |
CTRI/2024/03/064279 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Blood glucose level during laparoscopic surgeries |
|
Scientific Title of Study
|
Perioperative Capillary Blood Glucose level in Non-Diabetic Patients undergoing Laparoscopic Surgery: a Prospective study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Noyomi Saring |
| Designation |
Associate Profesor |
| Affiliation |
Tomo Riba Institute of Health and Medical Sciences |
| Address |
Department of Anaesthesiaology Tomo Riba Institute of Health and
Medical Sciences Naharlagun
Papum Pare
ARUNACHAL PRADESH
791110
India
Papu-nallah
Near Bharat Gas Godown
Naharlagun
Papum Pare
ARUNACHAL PRADESH
791110
India |
| Phone |
9436227174 |
| Fax |
|
| Email |
drnaomisaring@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Noyomi Saring |
| Designation |
Associate Profesor |
| Affiliation |
Tomo Riba Institute of Health and Medical Sciences |
| Address |
Department of Anaesthesiaology Tomo Riba Institute of Health and
Medical Sciences Naharlagun
Papum Pare
ARUNACHAL PRADESH
791110
India
Papu-nallah
Near Bharat Gas Godown
Naharlagun
Papum Pare
ARUNACHAL PRADESH
791110
India |
| Phone |
9436227174 |
| Fax |
|
| Email |
drnaomisaring@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Millo Apo |
| Designation |
Resident |
| Affiliation |
Tomo Riba Institute of Health and Medical Sciences |
| Address |
Department of Anaesthesiaology Tomo Riba Institute of Health and
Medical Sciences Naharlagun
Papum Pare
ARUNACHAL PRADESH
791110
India
Papum Pare
ARUNACHAL PRADESH
791110
India |
| Phone |
9436227174 |
| Fax |
|
| Email |
mapoapo100@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Noyomi Saring
Tomo Riba Institute of Health and Medical Sciences
Naharlagun
Papum Pare
Arunachal Pradesh
India - 791110 |
|
|
Primary Sponsor
|
| Name |
Noyomi Saring |
| Address |
Department of Anaesthesiaology Tomo Riba Institute of Health and
Medical Sciences Naharlagun
Papum Pare
ARUNACHAL PRADESH
791110
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Noyomi Saring |
Tomo Riba Institute of Health and Medical Sciences Naharlagu |
Department of Anaesthesiaology
Papum Pare
ARUNACHAL PRADESH |
9436227174
drnaomisaring@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF THE INSTITUTIONAL ETHICS COMMITTEE TOMO RIBA INSTITUTE OF HEALTH AND MEDICAL SCIENCES (TRIHMS) (SOCIETY UNDER THE GOVERNMENT OF ARUNACHAL PRADESH) ARUNACHAL PRADESH: NAHARLAGUN 791110 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for laparoscopic cholecystectomy without diabetes or not taking beta blocker or steroid will be included. The blood sugar estimation with capillary blood method will be done pre-operatively, 15 minutes after troker and 15 minutes of extubation |
|
| ExclusionCriteria |
| Details |
refusal for trial
Diabetic patients
Patient on Beta blocker
Patient on steroid |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood sugar at baseline, 15 mins of surgery |
Baseline and 15 minutes of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/03/2024 |
| 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 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
|
surgery of any kind is associated with injury and stress. The stress due to trauma may be assess by physical as well as laboratory data. One of the easily measureable lab data is blood sugar. Laparoscopic surgery is minimal access surgery which is thought to cause very minimal physical injury. Thereby, we plan to assess stress injury during laparoscopic surgery taking less than 2 hours by using blood sugar estimation in non-diabetic patient. |