CTRI

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CTRI Number

CTRI/2024/12/078682 [Registered on: 27/12/2024] Trial Registered Prospectively

Last Modified On:

09/12/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Single Arm Study

Public Title of Study

Study on the Impact of Intravenous Fluids on Metabolomic Changes in Diabetic Patients Undergoing Spine Surgery

Scientific Title of Study

Metabolomic Profiling of Diabetic Surgical Patients Receiving Perioperative Intravenous Fluids: A Pilot Study

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 Ravitej Bhat
Designation	Assistant Professor
Affiliation	Kasturba medica College, Manipal
Address	Department of Anesthesiology, KMC, Manipal Udupi KARNATAKA 576104 India
Phone	8123461967
Fax
Email	ravi.tej@manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Ravitej Bhat
Designation	Assistant Professor
Affiliation	Kasturba medica College, Manipal
Address	Department of Anesthesiology, KMC, Manipal Udupi KARNATAKA 576104 India
Phone	8123461967
Fax
Email	ravi.tej@manipal.edu

Details of Contact Person
Public Query

Name	Dr Ravitej Bhat
Designation	Assistant Professor
Affiliation	Kasturba medica College, Manipal
Address	Department of Anesthesiology, KMC, Manipal Udupi KARNATAKA 576104 India
Phone	8123461967
Fax
Email	ravi.tej@manipal.edu

Source of Monetary or Material Support

Manipal Academy of Higher Education, Manipal -576104

Primary Sponsor

Name	Dr. Ravitej Bhat
Address	Department of Anesthesiology, KMC, Manipal
Type of Sponsor	Other [Self sponsored]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ravitej Bhat	Kasturba Medical College, Manipal	Department of Neurosurgery, OR12, Baliga block,Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 Udupi KARNATAKA	9449990778 ravi.tej@manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
KMC and KH Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E08-E13\|\|Diabetes mellitus,

Intervention / Comparator Agent

Type	Name	Details
Intervention	0.9% normal saline and Ringer lactate solution	Dose:100ml/hr Frequency: continuous throughout intraoperative period Route of administartion:intravenous Duration: Intraoperative period

Inclusion Criteria

Age From	18.00 Year(s)
Age To	85.00 Year(s)
Gender	Both
Details	1. Adult patients (age 18 years or older) 2.Diagnosed with chronic diabetes mellitus (type 1 or type 2) for at least 1 year, scheduled to undergo elective spine surgery with ASA 2 and ASA 3 3. Able to provide informed consent

ExclusionCriteria

Details

1. Patients with presence of of active infection or sepsis
2. Emergency spine surgeries
3.Severe renal impairment
4. Severe hepatic impairment
5.Congestive heart failure
6.Immunocompromised state,Pregnant or lactating women, Inability to provide informed consent

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Untargeted GCMS to measure Metabolites.	Timepoint 1: Before induction of anesthesia in operation room Timepoint 2: 10 minutes after completion of laminectomy Timepoint 3: 60 minutes after shifting to recovery room

Secondary Outcome

Outcome	TimePoints
Type and volume of fluid administered. Hourly blood glucose level Time taken to recover from anesthesia. Post Surgical Complication	Timepoint 1: Before induction of anesthesia in operation room Timepoint 2: 10 minutes after completion of laminectomy Timepoint 3: 60 minutes after shifting to recovery room

Target Sample Size

Total Sample Size="10"
Sample Size from India="10"
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)

01/01/2025

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

Study will be initiated only after obtaining clearance from the institutional Ethics Committee. Patients will be screened based on the inclusion and exclusion criteria. Eligible chronic diabetic patients scheduled for elective spine surgery in neurosurgery department of KMC, Manipal will be enrolled after obtaining written informed consent. One of the investigators will be informing the patient regarding the study and the risk and benefits involved with it. Patient information sheet will be given to the patient and informed that participation is entirely voluntary. A written informed consent will be obtained from the patient and a copy of the same will be handed over to the patient. Blood will be drawn from the patient at below mentioned time points.

Blood sample collection:

Timepoint 1: Before induction of anesthesia in operation room

Timepoint 2: 10 minutes after completion of laminectomy

Timepoint 3: 60 minutes after shifting to recovery room

The blood serum samples collected at the three timepoints will be processed and stored for subsequent untargeted metabolomic analysis using GC-MS techniques.