| CTRI Number |
CTRI/2024/12/078536 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of Effect of Preoperative Oral Carbohydrate Intake Versus Fasting on Intraoperative Core Body Temperature Of Mother Undergoing Elective Lower Segment Casearean Section |
|
Scientific Title of Study
|
A Randomized Controlled Trial Comparing The Effect of Preoperative Oral Carbohydrate Intake Versus Conventional Fasting Protocol In Intraoperative Core Body Temperature Of Parturients Undergoing Elective Lower Segment Casearean Section |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Rao |
| Designation |
JR2 |
| Affiliation |
Bharati Vidyapeeth deemed to be university, |
| Address |
Department of Anaesthesiology,3rd floor, OT complex, BHarati hospital, pune
Major OT, Bharati hospital,pune
Pune
MAHARASHTRA
411037
India |
| Phone |
7987253805 |
| Fax |
|
| Email |
anjalirap892@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Rao |
| Designation |
JR2 |
| Affiliation |
Bharati Vidyapeeth deemed to be university, |
| Address |
Department of Anaesthesiology, 3rd floor, OT complex,Bharati hospital,Pune
Major OT, Bharati hospital,pune
Pune
MAHARASHTRA
411037
India |
| Phone |
7987253805 |
| Fax |
|
| Email |
anjalirap892@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Konnur |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth, Pune |
| Address |
Department of Anaestheisa,3r,Bharati hospital ,Pune floor,OT complex
Major OT, BHarati hospital, Pune
Pune
MAHARASHTRA
411037
India |
| Phone |
9823890369 |
| Fax |
|
| Email |
shwetaajm81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital OT Pharmacy, 3rd floor,OT complex,Bharati hospital,Pune |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital |
| Address |
Katraj, Pune |
| 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 Anjali Rao |
OBGY OT,1st floor ,Bharati Hospital |
Katraj, Pune
Pune
MAHARASHTRA |
7987253805
anjalirap892@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, (2) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preoperative carbohydrate drink |
250 ml oral drink 2 hr prior to elective LSCS |
| Comparator Agent |
Preoperative oral carbohydrate drink |
Preoperative oral carbohydrate 2 hours prior to LSCS compared with conventional fasting parturient |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Parturients of age 20-40 years posted for elective lower segment cessarean section under spinal anaesthesia.
2)Gestational age 38-40 weeks
3) A body mass index of upto 30kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Parturients refusal
2. Body temp more than 38 degrees
3. additional comorbidities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of preop carbohydrate drink on intraoperative maternal core body temperature |
Effect of preop carbohydrate drink on intraoperative maternal core body temperature at 30, 60 and 90 min after spinal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of shivering and cold perception score, side effect if any |
continuously throughout the surgery |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
06/01/2025 |
| 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 Applicable |
| 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
|
In this prospective randomised controlled trial we will compare the effect of preoperative oral carbohydrate intake versus conventional fasting protocol on the intraoperative core maternal body temperature undergoing elective cessarean section , Parturient will be divided into two groups ,Group 1: will recieve 250ml of carbohydrate drink 2 hour prior LSCS, Group 2: will be kept overnight fasted as per hospital protocol . Intraoperative tympanic membrane temperature will be recorded at 30,60,90 minutes after spinal anaesthesia ,Changes in the tympanic membrane temperature at each above mentioned time points wll be compared in both (preoperative carbohydrate group and fasting group), Incidence of shivering,, cold perception score and side effects will be noted as secondary outcomes. |