| CTRI Number |
CTRI/2020/01/023057 [Registered on: 31/01/2020] Trial Registered Prospectively |
| Last Modified On: |
06/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study to find the efficacy of intra operative 5% Dextrose administration on Post-Operative
Nausea Vomiting (PONV) in patients undergoing Laparoscopic Surgeries
|
|
Scientific Title of Study
|
Effect of intra operative dextrose administration on post operative nausea vomiting in patients undergoing laparoscopic surgery : a randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr kiran s |
| Designation |
professor |
| Affiliation |
Armed forces medical college |
| Address |
Department of anaesthesiology and critical care, Armed forces medical college,Pune
Pune
MAHARASHTRA
411047
India |
| Phone |
|
| Fax |
|
| Email |
drkirans@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr kiran s |
| Designation |
professor |
| Affiliation |
Armed forces medical college |
| Address |
Department of anaesthesiology and critical care armed forces medical college, Pune
Pune
MAHARASHTRA
411047
India |
| Phone |
|
| Fax |
|
| Email |
drkirans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr ankit kumar |
| Designation |
PG resident |
| Affiliation |
Armed forces medical college |
| Address |
Department of Anaesthesiology and critical care armed forces medical college, Pune
Pune
MAHARASHTRA
411047
India |
| Phone |
9560081831 |
| Fax |
|
| Email |
kumarankitster@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and critical care, Armed Forces Medical College,
Wanowrie,
Pune - 411040 |
|
|
Primary Sponsor
|
| Name |
Armed forces medical college pune |
| Address |
Department of Anaesthesiology and critical care Armed Forces Medical College
Wanowrie,
Pune 411040 |
| 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 |
| col kiran s |
Armed forces medical college |
Department of Anaesthesiology and critical care armed forces medical college, Pune
Pune
MAHARASHTRA |
9823464596
drkirans@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: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: O298||Other complications of anesthesiaduring pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5% dextrose |
500 ml of 5% Dextrose I.V intra operative over 30 minutes
RL will be administered as a maintenance IV fluid based on calculated fluid requirements |
| Comparator Agent |
Ringer lactate |
500ml of Ringer lactate intra operative i.v over 30 minutes
RL will be administered as a maintenance IV fluid based on calculated fluid requirements |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
A female patient aged from 18 – 45 years, ASA I and ASA II who will be undergoing GA for elective laparoscopic gynecological and laparoscopic cholecystectomy surgeries |
|
| ExclusionCriteria |
| Details |
All ASA III or more PS, Patient going for emergency surgery, patient with risk factor for aspiration of gastric contents, patient anticipating long-duration more than 02 hours, pregnancy, patient having known case of Diabetes mellitus, significant hepatic or renal failure, patient with Gastroesophageal reflux disease/peptic ulcer disease will be excluded from study. Abnormal preoperative blood glucose in post-anesthesia checkups and patients requiring a large volume of intravascular fluid treatment for intraoperative hypotension and patients with increased intracranial tension will also excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of post operative nausea vomiting with intra operative 5% Dextrose administration compared to Ringers Lactate in patients undergoing Laparoscopic Surgeries |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the severity of PONV, post-operative antiemetic requirement, and post-operative
glucose levels with administration of 5% Dextrose compared to Ringers Lactate in patients
undergoing Laparoscopic Surgeries
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
Modification(s)
|
17/02/2020 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
post operative nausea vomiting (PONV) is major complication after lap surgery the incidence of nausea is around 50% and after general anaesthesia it is essential to identify non pharmacological strategies to mininmize the incidence of PONV especially in high risk patient |