| CTRI Number |
CTRI/2023/06/053420 [Registered on: 01/06/2023] Trial Registered Prospectively |
| Last Modified On: |
01/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of carbohydrate drink before caesarean delivery on body temperature during anaesthesia |
|
Scientific Title of Study
|
The effect of preoperative oral carbohydrate loading on body temperature in elective caesarean delivery under spinal anaesthesia: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusha G Haramagatti |
| Designation |
Junior Resident |
| Affiliation |
KIMS, Hubli |
| Address |
Department of Anesthesiology,
Karnataka Institute of Medical Sciences,
Hubli
Karnataka
India
Dharwad
KARNATAKA
580021
India |
| Phone |
9483975078 |
| Fax |
|
| Email |
anusha.haramagatti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa S |
| Designation |
Associate professor |
| Affiliation |
KIMS, Hubli |
| Address |
Department of Anesthesiology,
Karnataka Institute of Medical Sciences,
Hubli
Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
9448658220 |
| Fax |
|
| Email |
roopasac@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa S |
| Designation |
Associate professor |
| Affiliation |
KIMS, Hubli |
| Address |
Department of Anesthesiology,
Karnataka Institute of Medical Sciences,
Hubli
Karnataka
Dharwad
KARNATAKA
580021
India |
| Phone |
9448658220 |
| Fax |
|
| Email |
roopasac@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Karnataka Institute of Medical Sciences |
| Address |
Department of Anesthesiology,
Karnataka Institute of Medical Sciences,
Vidyanagar, Hubli
Karnataka 580021 |
| Type of Sponsor |
Government 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 |
| Anusha G Haramagatti |
Karnataka Institute of Medical Sciences |
Department of Anesthesiology
Karnataka Institute of Medical Sciences,
Vidyanagar, Hubli
Karnataka 580021
Dharwad
KARNATAKA |
9483975078
anusha.haramagatti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Karnataka Institute of Medical Sciences, Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O898||Other complications of anesthesiaduring the puerperium, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preoperative carbohydrate loading |
Dose- 250ml of clear apple juice (tetra pack) containing 34 grams of carbohydrate (39.6grams carbohydrate, kcal-157.6, Sodium mg- 42.6mg)
Route - oral
Frequency- Given once 2 hours prior to caesarean section
Duration- 2 hours prior to caesarean section |
| Comparator Agent |
Preoperative water loading |
Dose- 250ml of water
Route - oral
Frequency- once 2 hours prior to caesarean section
Duration- 2 hours prior to caesarean section |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA II undergoing elective caesarean section under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1 Preoperative hyperthermia (>38°C) or hypothermia (<36 °C)
2 BMI>30 Kg/m2
3 Patients with diabetes mellitus, hypertension, hypothyroid or hyperthyroid, anemia
4 Patients with delayed gastric emptying, hyperemesis gravidarum until late pregnancy, or consumption of drugs that affect gastrointestinal motility within 3 days before surgery.
5 Patients who failed to drink the carbohydrate drink as prescribed before surgery
6 Patients with ear disease
7 Surgical time >1.5 hours
8 Intraoperative blood transfusion |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased change in the body temperature intraoperatively |
-15 minutes prior to caesarean delivery
-Immediately after induction
-At the end of delivery
-1 hour 30 minutes after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Decreased incidence of intra operative & postoperative shivering
• Decreased incidence of nausea & vomiting in postoperative period |
-Shivering upto 1 hour 30 minutes
-Nausea & vomiting upto 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)
|
12/06/2023 |
| 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="1"
Months="0"
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
|
Hypothermia after surgery is a common complication. This leads to redistribution of central heat to the periphery and overall heat loss. The clinical consequences include patient discomfort, shivering, platelet dysfunction, coagulopathy, and increased vasoconstriction associated with a higher risk of wound infection. Nutrient induced thermogensis may prevent intraoperative hypothermia. Oral carbohydrate loading two hours before surgery may facilitate body temperature maintenance during caesarean section.Aim: Oral carbohydrate loading two hours prior to caesarean delivery may decrease the change in the body temperature intraoperatively.
Objectives: - To evaluate the effect of preoperative oral carbohydrate loading on intraoperative body temperature. - To assess effect of carbohydrate drink intraoperative and postoperative shivering. - To assess effect of carbohydrate drink on incidence of nausea and vomiting in postoperative period.
Materials and methods: A Prospective Randomized controlled trial.
Sample size: 30 patients in each group.
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