| CTRI Number |
CTRI/2025/04/084327 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of preoperative oral carbohydrate loading in elective caesarean patients under spinal anaesthesia |
|
Scientific Title of Study
|
Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance Assessed using HOMA -IR in Elective Lower Segment Cesarean Section Patients done under Spinal Anesthesia - A Randomized Prospective Parallel Arm Double Blinded 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 |
Hariharan ps |
| Designation |
Consultant - Anesthesiologist |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
Room no 5
Department of Anaesthesia
A4 Hospitals and Fertility centre
No 87 arcot road virugambakkam
Chennai
TAMIL NADU
600092
India |
| Phone |
9443371594 |
| Fax |
|
| Email |
drhariharan@a4fertility.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hariharan ps |
| Designation |
Consultant - Anesthesiologist |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
Room no 5
Department of Anesthesia
A4 Hospitals and Fertility centre
87, Arcot Road Virugambakkam
Chennai
TAMIL NADU
600092
India |
| Phone |
9443371594 |
| Fax |
|
| Email |
drhariharan@a4fertility.com |
|
Details of Contact Person
Public Query
|
| Name |
Hariharan ps |
| Designation |
Consultant - Anesthesiologist |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
Room no 5
Department of Anesthesia
A4 Hospital and Fertility centre
No 87 A4cot road virugambakkam
Chennai
TAMIL NADU
600092
India |
| Phone |
9443371594 |
| Fax |
|
| Email |
drhariharan@a4fertility.com |
|
|
Source of Monetary or Material Support
|
| A4 Hopsitals and Fertility centre,87, arcot road , virugambakkkam, Chennai - 600092, tamilnadu, india. |
|
|
Primary Sponsor
|
| Name |
Dr Hariharan |
| Address |
Consultant - anesthesiologist,
A4 hospital and fertility centre,87 arcot road,vurgambakkam, chennai - 600092. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Hariharan |
A4 hospital and Maternity centre |
Room no 5
Department of Anesthesia
10/1, radhakrishna salai, valasaravakkam, chennai-600087
Chennai
TAMIL NADU |
9443371594
drhariharan@a4fertility.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A4 Hospital - instituitional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (2) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carbohydrate drink |
Giving carbohydrate load 2 hours prior to surgery for pregnant patient posted for elective LSCS, Surgicab (lifecare (bioscience))- carbohydrate drink of 355ml contains 200gm of calories |
| Comparator Agent |
Clear water |
giving clear water 2 hours prior to surgery for pregnant patient posted for elective LSCS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Female |
| Details |
Singleton term gestation
Uncomplicated pregnancy - patients scheduled for an elective cesarean delivery - planned under spinal anesthesia (ASA II).
|
|
| ExclusionCriteria |
| Details |
Patient not willing for study
ASA 3 and above
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be pregnant women perioperative insulin resistance will be evaluated by the homeostatic model assessment of insulin resistance (HOMA-IR) index |
2nd day of POD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gastric volume assessments will be done before spinal anaesthesia, in order to assess the gastric content prior to anaesthesia done by separate experienced anaesthesiologist.
Neonatal indices regarding the well-being of the newborn were recorded from medical records, including one-minute & five-minute APGAR scores recorded at delivery
Neonatal Capillary blood glucose level will be measured on heel within 20 min after delivery
Time of flatus passed will be noted.
Duration of hospital stay - from completion of caesarean section to time of discharge in hours
Intra- or postoperative nausea & vomiting were asked for 24 hours - the Wengritzky Scale |
Gastric volume before surgery
Wengritzky scale post surgery 24 hours |
|
|
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)
|
05/01/2027 |
| 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
|
A single dose of carbohydrate reduces postoperative insulin resistance, glyconeogenesis, glycogenolysis, and lipolysis It also minimizes muscle protein catabolism and allows glucose accumulation in the liver to be stored as glycogen. The aim of preoperative administration of carbohydrate solution before surgical intervention is to increase glycogen storage in the body and reduce possible tissue damage and insulin resistance. Administration of these liquids during the perioperative period has been reported to increase patient comfort, reduce the patient’s anxiety level, and shorten the hospital stay. Aim is To compare the effect of preoperative oral carbohydrate drink on insulin resistance using HOMA –IR in elective lower segment caesarean section patients under spinal anaesthesia with ERAS recommended perioperative fasting guidelines vs conventional fasting method.Single centre – parallel arm , prospective study Double blinded (outcome assessor/primary investigator) Randomized controlled trial Group I included patients randomized to receive oral carbohydrate drinks (CHO) Group II included patients randomized to serve as controls and receive standard fasting (SF).
|