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Clinical Trials/CTRI/2024/12/078536
CTRI/2024/12/078536Not yet recruitingNot Applicable

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

Bharati Hospital1 site in 1 country140 target enrollmentStarted: January 6, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
140
Locations
1
Primary Endpoint
Effect of preop carbohydrate drink on intraoperative maternal core body temperature

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Investigator Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Parturients of age 20-40 years posted for elective lower segment cessarean section under spinal anaesthesia.
  • Gestational age 38-40 weeks 3) A body mass index of upto 30kg/m2.

Exclusion Criteria

  • Parturients refusal
  • Body temp more than 38 degrees
  • additional comorbidities.

Outcomes

Primary Outcomes

Effect of preop carbohydrate drink on intraoperative maternal core body temperature

Time Frame: Effect of preop carbohydrate drink on intraoperative maternal core body temperature at 30, 60 and 90 min after spinal

Secondary Outcomes

  • incidence of shivering and cold perception score, side effect if any(continuously throughout the surgery)

Investigators

Sponsor
Bharati Hospital
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Anjali Rao

Bharati Vidyapeeth deemed to be university,

Study Sites (1)

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