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临床试验/CTRI/2024/07/071369
CTRI/2024/07/071369尚未招募不适用

To assess the actual duration of preoperative fasting in paediatric patients undergoing surgeries under general anaesthesia and its effects on hunger and thirst in preoperative period, a prospective observational study

未提供1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
96
试验地点
1
主要终点
To determine the actual duration of preoperative fasting in paediatric population and its effects on hunger and thirst

研究概览

简要总结

TITLE OF STUDY

To Assess The Actual Duration Of Preoperative Fasting In Paediatric Patients Undergoing Surgeries Under General Anaesthesia And Its Effects On Hunger And Thirst In Preoperative Period A Prospective Observational Study

INTRODUCTION

Prolonged preoperative fasting is associated with numerous deleterious effects and stress response to surgery. Multiple anesthesia guidelines from various anesthesia associations have reviewed the preoperative fasting recommendations to reduce prolonged preoperative fasting. Although the guidelines recommend that preoperative fasting for solids and non human milk should be 6 hours and for clear fluids should be 2 hours , the actual fasting times of patients are far from these recommendations.

AIMS AND OBJECTIVES

AIM

To record starvation time to food and clear liquids ,hunger score and thirst score preoperatively

OBJECTIVES

To find out relation between awake fasting time ,administration of intravenous fluid and anesthesia start time with preoperative hunger and thirst score

To know the reason for unacceptable starvation time preoperatively

MATERIALS AND METHODS

This will be a prospective , observational study to be carried out at Tertiary care hospital after approval from Hospital Ethical committee and Departmental permission.

SELECTION OF PATIENTS

Inclusion criteria :

Age 7-12 years

Either gender

ASA Grade I or II

Elective Surgery

Consent (written informed assent was obtained from participant)

Exclusion criteria :

Non consent

ASA Grade III and above

Emergency procedure

Fasting due to medical and surgical or medical indication other than preoperative fasting

Neurological impairment

Communication barrier like deaf and mute child

Pre-anaesthetic Assessment-

Thorough medical and surgical history of the patient, clinical evaluation and details of current

medications will be recorded.

Preoperative Investigations:

-Age, weight and Baseline vital parameters

-Complete blood count, Renal function test, liver function test, serum     electrolytes, PT INR

  • General and Systemic Examination

  • Written informed consent from parents on the day of surgery

DETAILS OF RESEARCH PLAN : After obtaining institutional Ethics Committee

approval and written informed consent from parents in the language best understood by them,

All parents will be instructed about the fasting guidelines one day prior surgery. Children will be

allowed to fast for 8 hours after full meal,6 hours after snacks and milk and 2 hours after clear

liquid (4 ml/kg). after completion of starvation hours as per guidelines, Child will be started with

administration of ringer lactate intravenous fluid at maintenance rate as per holiday segar

formula

Weight in kg Maintenance fluid (requirement per hour/kg)

<10 kg 4 ml/kg/ hr

10-20 kg 40 ml+2ml/kg for every kg > 10 kg

20 kg 60 ml+1 ml/kg for every kg>20 kg

After arrival in operation theatre, all participants and their parents will be asked for last time the

participants ate food and drank liquid prior to surgery and the same will be recorded. If

starvation time is beyond the recommended time, then reason for same will be asked eg- sleeping

child, refusal for intake, nausea and pain in child, inadequate parental information about fasting

guidelines, less motivated parents etc. Starvation time is the time between their last oral intake

and start of general anaesthesia. Starvation time when child is in awake state after night sleep

will also be noted. Maintenance fluid received by the participants will also be noted. Hunger and

thirst score will be assessed for participants just prior shifting patient to operation theatre.

Hunger score and Thirst score will be self-rated using a 0 to10 scale (0 is feeling not hungry or

thirsty, 10 is feeling extremely hungry or thirsty) by the participants. Unacceptable starvation time

is defined as a starvation time more than two times the recommended fasting duration. Therefore,

the unacceptable fasting duration for full meal, snacks and clear water will be more than 16 hours,12 hours and 4 hrs respectively.

研究设计

研究类型
Observational

入排标准

年龄范围
7.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Age 7 to 12 Either gender ASA Grade I or II Elective Surgery Consent(written informed assent was obtained from participant).

排除标准

  • Non consent ASA Grade III and above Emergency procedure Fasting due to medical and surgical or medical indication other than preoperative fasting Neurological impairment Communication barrier like deaf and mute child.

结局指标

主要结局

To determine the actual duration of preoperative fasting in paediatric population and its effects on hunger and thirst

时间窗: Time since last oral intake of solids or liquids in paediatric patient till the child is just taken inside the operation theatre for induction of anaesthesia | The hunger and thirst score to be assessed when the child is just taken inside operation theatre for induction of anaesthesia

次要结局

  • 1)To record starvation time to food & clear liquids, hunger score & thirst score preoperatively(2)To find out relation between awake fasting time, administration of intravenous fluid & anaesthesia start time with preoperative hunger & thirst score)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

DrSushama R Tandale

BJ Government medical college and Sassoon Hospital ,Pune

研究点 (1)

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