| CTRI Number |
CTRI/2022/01/039159 [Registered on: 05/01/2022] Trial Registered Prospectively |
| Last Modified On: |
04/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [fluid administration] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two different type of fluids in emergency laparotomy patients |
|
Scientific Title of Study
|
Comparative study of ringer lactate and balanced salt solution on acid base and electrolyte status in emergency laparotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramik chaudhary |
| Designation |
Junior resident |
| Affiliation |
IMS BHU VARANASI |
| Address |
department of anesthesiology , IMS,BHU
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8447859045 |
| Fax |
|
| Email |
ramikchaudhary01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yaspal singh |
| Designation |
Profeesor |
| Affiliation |
IMS,BHU,VARANASI |
| Address |
Department of anesthesiology,IMS,BHU,varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9918424416 |
| Fax |
|
| Email |
dryashacin1999@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Yaspal singh |
| Designation |
Profeesor |
| Affiliation |
IMS,BHU,VARANASI |
| Address |
Department of anesthesiology,IMS,BHU,varanasi
UTTAR PRADESH 221005 India |
| Phone |
9918424416 |
| Fax |
|
| Email |
dryashacin1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE OF MEDICAL SCIENCES, BHU |
|
|
Primary Sponsor
|
| Name |
Institute of medical science Banaras Hindu university |
| Address |
Department of anesthesiology, institute of medical science, BHU, varanasi UP,INDIA 221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ramik Chaudhary |
Sir Sundarlal Hospital |
Department of anesthesiology , IMS,BHU Varanasi UTTAR PRADESH |
8447859045
ramikchaudhary01@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: K631||Perforation of intestine (nontraumatic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Balanced salt solution |
Group B will receive Balanced Salt Solutions as intraoperative maintenance fluid up to 6 hours postoperatively. |
| Intervention |
Ringer lactate |
Group R will receive Ringer Lactate as intraoperative maintenance fluid up to 6 hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient received from emergency of SSH within 24 hrs of admission after resuscitation. |
|
| ExclusionCriteria |
| Details |
1-Patients/relative refusal.
2-patient on high inotropic support.
3-patient with any systemic illness like diabetes, hypertension etc.
4-patient with end stage organ damage eg.hepatic renal or cardiovascular disorder.
5-patient with abdominal trauma. |
|
|
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 |
| Changes in Acid-base and electrolyte status (ABG analysis) |
-Preoperative,
-After extubation
-6 hours after extuabtion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Associated side effects |
6hr postop |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
10/01/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Our study include total 60 patients of intestinal obstruction and perforation undergoing emergency exploratory laparotomy. After Ethical approval, Written informed consent from each patient or his relative will be taken before the procedure. Inclusion Criteria: 1. Age group between 18 and 60 years. 2. Patient received from emergency of SSH within 24hr of admission after resuscitation. Exclusion criteria 1. Patient/relative refusal. 2. Patient on high inotropic support. 3. Patient with any systemic illness like Diabetes, Hypertension etc. 4. Patient with end stage organ damage e.g. hepatic, renal or cardiovascular disorder. 5. Patients with abdominal trauma. The patients will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque envelope technique into two equal groups (each 30 patients). Group R: Will receive Ringer Lactate as intraoperative maintenance fluid. Group B: Will receive Balanced Salt Solution as intraoperative maintenance fluid up to 6 hours postoperatively. Patient received in emergency department will be managed and resuscitated as per protocol for management of intestinal obstruction/perforation. Baseline investigations including arterial blood gas (ABG) analysis will be sent. Written informed consent will be taken from all patients before surgical intervention. Those patients will be enrolled in our study who meet the inclusion criteria. Demographic profile and baseline parameters will be recorded. Laparotomy will be done under general anaesthesia with epidural catheter in place for post op analgesia. ABG will be repeated immediately after extubation and 6 hour’s postoperatively. pH, base excess, serum bicarbonate, sodium, potassium, chloride, lactate and serum osmolality will be recorded and compared between two groups. |