| CTRI Number |
CTRI/2024/04/065984 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of intraoperative administration of three types of intravenous fluids on postoperative serum sodium levels in patients undergoing lower limb orthopedic surgeries |
|
Scientific Title of Study
|
Effect of intraoperative use of Isotonic
Saline, Ringer’s Lactate and a combination
of both on postoperative serum sodium levels
in lower limb orthopedic surgeries- A double
blind randomized 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 |
Rakshitha BM |
| Designation |
Post Graduate student |
| Affiliation |
SDM College of Medical Sciences and Hospital, Dharwad |
| Address |
Department of Anaesthesiology
SDM College of Medical Sciences and Hospital
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9591379424 |
| Fax |
|
| Email |
rakshitabm8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Archana A Bharadwaj |
| Designation |
Associate Professor |
| Affiliation |
SDM College of Medical Sciences and Hospital, Dharwad |
| Address |
Department of Anaesthesiology
SDM College of Medical Sciences and Hospital
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8437373388 |
| Fax |
|
| Email |
archana.a.b16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana A Bharadwaj |
| Designation |
Associate Professor |
| Affiliation |
SDM College of Medical Sciences and Hospital, Dharwad |
| Address |
Department of Anaesthesiology
SDM College of Medical Sciences and Hospital
Dharwad
KARNATAKA
580009
India |
| Phone |
8437373388 |
| Fax |
|
| Email |
archana.a.b16@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Medical Sciences and Hospital, Dharwad |
|
|
Primary Sponsor
|
| Name |
SDM College of Medical Sciences and Hospital, Dharwad |
| Address |
department of Anaesthesiology
SDM College of Medical Sciences and Hospital, Dharwad |
| Type of Sponsor |
Private 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 Rakshitha BM |
SDM College of Medical Sciences and Hospital, Dharwad |
OT number 7 and 8 (orthopedics ), Main OT Complex, SDM College of Medical Sciences and Hospital, Dharwad
Dharwad
KARNATAKA |
9591379424
rakshitabm8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM College of Medical Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group IS +RL |
Group IS +RL: Patients will be administered
alternatively with intravenous Isotonic saline and Ringer’s lactate
intraoperatively and postoperatively from the time
patient is taken to the OR till 6 hours after surgery. A
maximum difference between IS and RL administered
will be no more than 250mL.
total duration of administration: 7 hours |
| Comparator Agent |
Group IS |
Patients will be administered with intravenous Isotonic
saline (IS) intraoperatively and postoperatively from the
time the patient is taken to the operating room (OR) till
6 hours after surgery. Total duration of infusion 7 hours |
| Comparator Agent |
Group RL |
Patients will be administered with intravenous Ringers Lactate (RL) intraoperatively and postoperatively from the
time the patient is taken to the operating room (OR) till
6 hours after surgery. total duration of infusion 7 hours. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for lower limb orthopedic
surgeries
ASA physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients with abnormal serum sodium levels on the
day of surgery
Patients with Acute kidney injury
head injury
congestive cardiac failure
liver cirrhosis
hyperglycemia
Pregnant women
Patients on medications such as thiazide diuretics and warfarin
Any contraindication to subarachnoid block |
|
|
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 |
| Change in serum sodium levels from preoperative to postoperative period |
time point A :preoperative value on the morning of surgery
time point B: 6h after surgery
time point C: 24h after time point B |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of hyponatremia |
time point B: 6h after surgery
time point C: 24h after time point B |
) Incidence of post operative nausea and vomiting
in the first 24 hours after surgery |
time point C: 24 h after time point B (6 h after surgery) |
Incidence of post operative confusion/ delirium
in the first 24 hours after surgery |
time point A :preoperative value on the morning of surgery
time point B: 6h after surgery
time point C: 24h after time point B |
| length of hospital stay |
at the time of discharge |
|
|
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)
|
02/05/2024 |
| 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="2"
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
|
After obtaining permission from the institutional ethical committee
and written informed consent from the patients, patients will be
recruited in this prospective double blind randomized controlled trial.
Preanaesthetic examination and preparation:
Patients will undergo routine preanaesthetic examination before
considering for surgery. Patients who fulfill the above-mentioned
inclusion criteria will be enrolled in the trial after obtaining a written
informed consent.Patients will be instructed to follow standard ASA
preoperative fasting guidelines (6h for solids and non-clear liquids
and 2 h for clear liquids) and premedicated with oral pantoprazole 40
mg on the previous night of surgery.
On the day of surgery, we will reassess the patients in
preoperative room.
Confusion Assessment Method (CAM) tool will be applied to rule
out confusion/ delirium in the patient. An intravenous (IV) access with a wide bore cannula will be secured
and the baseline vitals like Heart rate, Blood pressure and SpO2
recorded. A Blood sample will be drawn and sent for estimation of
serum sodium levels, which will be noted as baseline levels.
The patients will then be randomly allotted into one of the three
groups (based on a computer-generated random number table):
Group IS -Patients will be administered with Isotonic saline
intraoperatively and postoperatively from the time the patient is taken
to the operating room (OR) till 6 hours after surgery.
Group RL-We will be administered with Ringer’s lactate
intraoperatively and postoperatively from the time patient is taken to
the OR till 6 hours after surgery.
Group IS +RL -We will be administered with Isotonic saline and
Ringer’s lactate intraoperatively and postoperatively from the time
patient is taken to the OR till 6 hours after surgery.
Blinding process : Allotment of the patient to any group will not be
known to the principal investigator. Intraoperatively, the name of the
IV fluid will be concealed using a white paper by the OR anaesthesia
technician. The patient will not be told to which group he/ she
belongs to. This is a double-blind RCT.
In the OR, IV fluids will be administered according to Holliday Segar formula to cover fasting requirements [1]
.
Maintenance rate of the fluid will be administered as per the weight
of the patient throughout the surgery. The patients will be administered spinal
anaesthesia as per the attending anaesthesiologist. Any requirement
for transfusion of any blood products will be noted. After the surgical
procedure the patient is shifted to the post anaesthesia care unit
(PACU) and monitored for 1 hour. IV fluid will be administered as
per the trial group the patient belongs to till 6 hours post-surgery.
Complaints like lethargy, confusion will be noted.
At 6 hours post-operatively, the administration of IV fluid will be
stopped and a blood sample will be drawn and sent to the laboratory
for the estimation of Serum sodium levels. Another blood sample for
Serum sodium level estimation will be drawn and sent again after 24
hours from this time-point.
Post operative nausea and vomiting will be observed for 24 hours of
surgery.
Assessment for confusion/ delirium will be performed using CAM:
1. Immediately when the patient is
shifted to PACU
2. 6 hours post-surgery in the ward
(Time point B)
3. 24 hours after time-point B (time point C) in the ward
The patient will be followed up till the day of discharge. |