| CTRI Number |
CTRI/2024/03/063644 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of a drug on postoperative blood sugar |
|
Scientific Title of Study
|
EFFECT OF A SINGLE INTRAOPERATIVE DOSE OF DEXAMETHASONE ON GLYCEMIC PROFILE IN POST OPERATIVE PATIENTS, UNDERGOING ELECTIVE LAPAROSCOPIC SURGERY UNDER GENERAL ANAESTHESIA: RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
jyoti |
| Designation |
PG resident |
| Affiliation |
Dr SN Medical College, Jodhpur , Rajasthan |
| Address |
Department of anaesthesiology and critical care, Dr SN Medical College, Jodhpur , Rajasthan
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9050702606 |
| Fax |
|
| Email |
jyotidhiman23456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Fateh Singh Bhati |
| Designation |
Senior Professor at department of anaesthesiology at Dr SN Medical College, Jodhpur |
| Affiliation |
Dr SN Medical College, Jodhpur , Rajasthan |
| Address |
Department of anaesthesiology and critical care, Dr SN Medical College, Jodhpur , Rajasthan
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9414127176 |
| Fax |
|
| Email |
fatehbhati68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fateh Singh Bhati |
| Designation |
Senior Professor at department of anaesthesiology at Dr SN Medical College, Jodhpur |
| Affiliation |
Dr SN Medical College, Jodhpur , Rajasthan |
| Address |
Department of anaesthesiology and critical care, Dr SN Medical College, Jodhpur , Rajasthan
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9414127176 |
| Fax |
|
| Email |
fatehbhati68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr SN Medical College Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr SN Medical College Jodhpur |
| Address |
Dr SN Medical College Jodhpur, Shastri Nagar , Residency Road , Jodhpur Rajasthan 342001 |
| 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 |
| Dr jyoti |
MDM Hospital |
Operation theatre , first floor Department of anaesthesiology and critical care,Dr SN Medical College,Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
9050702606
jyotidhiman23456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Dr SN Medical College Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K829||Disease of gallbladder, unspecified, (2) ICD-10 Condition: K829||Disease of gallbladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EFFECT OF A SINGLE INTRAOPERATIVE DOSE OF DEXAMETHASONE ON GLYCEMIC PROFILE IN POST OPERATIVE PATIENTS, UNDERGOING ELECTIVE LAPAROSCOPIC SURGERY |
There are two groups one will receive 8mg dexamethasone that is 2ml diluted up to 5 ml ,in addition to other drugs and other group will receive placebo that is normal saline 5 ml in addition to other drugs , intraoperatively after induction of anaesthesia and effect on glycemic profile , episodes and severity of nausea vomitting and pain score is seen in both the groups postoperatively 12 hourly upto 72 hours |
| Intervention |
EFFECT OF A SINGLE INTRAOPERATIVE DOSE OF DEXAMETHASONE ON GLYCEMIC PROFILE IN POST OPERATIVE PATIENTS, UNDERGOING ELECTIVE LAPAROSCOPIC SURGERY UNDER GENERAL ANAESTHESIA |
In this study , i will see the effect of single dose that is 8 mg of dexamethasone given intravenously ,intraoperatively after induction of anaesthesia in patients undergoing laparoscopic surgery and glycemic profile is measured 12 hourly for 72 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patients of aged 18-70 years with Body Mass Index (BMI) ranging from 18.5 to 24.9 kg/m2, American Society of Anesthesiologists (ASA) physical status I and non-diabetic ASA II status posted for elective laparoscopic surgery will be recruited and studied for 72 hours. |
|
| ExclusionCriteria |
| Details |
Candidates with preexisting diabetes mellitus (FBS more than 126 mg/dl, postprandial blood sugar (PPBS) more than 200 mg/dl, HbA1c more than 6.5),
Chronic steroid therapy (taking steroid more than 10mg, for more than 10 days within last 10 months),
History of allergy to dexamethasone, Pregnancy,
History of peptic ulcer disease,
Malignancy,
Duration of anaesthesia more than 2 hours,
Patients who have history of any vomiting,
Retching, or nausea in the 24 hours preceding the administration of anaesthesia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in the glycemic profile up to 72hours in patients receiving a single dose of dexamethasone in elective laparoscopic surgery |
To compare the changes in the glycemic profile up to 72hours in patients receiving a single dose of dexamethasone in elective laparoscopic surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of postoperative nausea and vomiting (PONV)
And Postoperative pain in term of VAS score. |
Number of nausea and vomiting episodes will be documented 12 hourly and grading will be done accordingly.
And Postoperative pain will be assessed and documented 12 hourly by using Visual Analogue Scale |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="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
|
This study will be conducted in the department of Anaesthesiology, Dr. S. N. MEDICAL COLLEGE and associated group of hospitals on patients posted for laparoscopic surgery . The aim is to study the effect of a single dose of dexamethasone on glycemic profile up to 72hours in postoperative patients undergoing elective laparoscopic surgery under general anaesthesia and also to compare the incidence of postoperative nausea and vomiting (PONV) and Postoperative pain in term of VAS score. |