| CTRI Number |
CTRI/2025/03/082778 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Blood glucose concentration after two doses of dexamethasone
for prophylaxis of Post-operative Nausea and vomiting in Gynaecological Laparocopic surgeries |
|
Scientific Title of Study
|
A Prospective, Double-Blind, Randomized Controlled study Assessing the Perioperative Glycemic Response following Two Doses of Dexamethasone for Postoperative Nausea and Vomiting Prophylaxis in Gynecological Laparoscopic Surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bandari Vamshi sai |
| Designation |
Post graduate |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Department ofAnaesthesiology, Rajarajeswari Medical college andHospital,Mysoreroad,kambipura,Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9246898385 |
| Fax |
|
| Email |
Bandarivamshisai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti Petkar |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Department of Anaesthesiology, Rajarajeswari Medical college and Hospital,Mysore road,kambipura,Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
7726899533 |
| Fax |
|
| Email |
jokiran2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Petkar |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Department of Anaesthesiology, Rajarajeswari Medical college and Hospital,Mysore road,kambipura,Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
7726899533 |
| Fax |
|
| Email |
jokiran2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Medical College and Hospital,Mysore Road,Kambipura,Bangalore Bangalore
KARNATAKA 560074 India |
|
|
Primary Sponsor
|
| Name |
Bandari Vamshi sai |
| Address |
Rajarajeswari Medical College andHospital,MysoreRoad,Kambipura,Bangalore KARNATAKA 560074 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 Bandari vamshi sai |
Rajarajeswari medical college and hospital |
2nd floor hospital
building,department of
Anaesthesiology,Rajarajeswari medical college and hospital,kambipura
Bangalore
KARNATAKA |
09246898385
Bandarivamshisai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y69||Unspecified misadventure during surgical and medical care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Dexamethasone |
Dexamethasone 4mg(Group -A) IV given for non diabetic female patients undergoing laparoscopic gynaecological surgeries. |
| Comparator Agent |
Injection Dexamethasone. |
Dexamethasone 8mg (Group-B) IV given for non diabetic female patients undergoing laparoscopic gynaecological surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA-1,ASA-2 patients undergoing elective laparoscopic surgeries under general anaesthesia
Non-diabetic patients
Hba1c less than 5.6
Bodymassindex less than 30kg/m2 |
|
| ExclusionCriteria |
| Details |
Preoperative use of corticosteroids, insulin
Pregnancy
Preoperative fasting blood glucose levels more than 126mg/dl,Hba1c more than 6.5,
Malignancy,
Immunosuppression,Diabetic patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood sugar values |
1st hour,2nd hr,3rd hr After dexamethasone Administration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative nausea & vomiting |
Post operative period 8th hour,POD 1 2 3 |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 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
|
Double blinded, randomized, controlled study,Written informed consent will be taken from willing patients posted for elective surgery under general anesthesia. Pre operative blood sugar values will be documented along with age, gender,body mass index, type of surgery.Double blinding will be ensured by using preloaded 2 ml syringe of dexamethasone of 4 mg (groupA) and Dexamethasone 8mg (group B), prepared by an anesthesia resident unaware of allocation, after the opening of a sealed opaque envelope containing the randomized assignment. Patients will be allocated in 2 groups: non-diabetics receiving Dexamethasone 4mg ; Non diabetics receiving dexamethasone 8mg.The study drug will be administered after induction of anesthesia. No dextrose containing solution will be administered during the study. In the OT after attaching standard ASAmonitors, anesthesia will be induced with propofol iv after premedication with intravenousglycopyrrolate, Midazolam, ondansetron 4mg, fentanyl. Muscle relaxation will be achieved with atracurium 0.5mg/kg and endotracheal intubation done. At the end of surgery patients will be extubated after reversal of neuromuscular blockade. For the patient intraoperatively blood glucose monitoring will be done as per protocol.All blood glucose levels will be measured using a calibrated glucometer, SD code free (SD Biosensor,Inc.).The blood glucose measurements will be obtained from finger prick capillary blood samples, by anaesthesiology resident blinded to study group The total amount of insulin administered for the treatment of perioperative hyperglycemia will be recorded . Blood sugar values after dexamethasone administration on POD 1,2,3 will be taken as primary endpoints. PONV will be assessed using a 4-point verbal descriptive scale which consists of score 0=no PONV, score1 = mild PONV: patient complaints of nausea but refuses antiemetic treatment, score 2 = moderate PONV: patient complaints of nausea and needs antiemetic treatment; score 3= severe PONV. Patients who experience PONV in the recovery area will be treated with intravenous metoclopramide (10 mg) |