跳至主要内容
临床试验/CTRI/2025/12/098522
CTRI/2025/12/098522尚未招募不适用

A Prospective Randomized Controlled Clinical Study on the Effect of Oral Maltodextrin Administration Versus Conventional Fasting in the Preoperative Period Among Patients Undergoing ENT Surgeries Under General Anaesthesia

D Y Patil University School of Medicine and Hospital Nerul Navi Mumbai1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1

研究概览

简要总结

Prolonged preoperative fasting can lead to catabolic metabolism, muscle breakdown, insulin resistance, hyperglycemia, discomfort, and increased metabolic stress.

Preoperative carbohydrate (CHO) loading, especially with maltodextrin, counters these effects by improving insulin sensitivity, reducing stress response, stabilizing hemodynamics, and increasing patient comfort.

Aim— To evaluate the effect of preoperative oral maltodextrin loading on hemodynamic stability in patients undergoing general anaesthesia.

Primary Objective--Compare hemodynamic changes (HR, BP, MAP) between maltodextrin-loaded patients and conventionally fasted patients.

Secondary Objective--Assess hunger, thirst, and overall satisfaction before induction.

All eligible patients will be screened for inclusion and informed consent was obtained. Participants were then randomly allocated into Group A or Group B. Preoperative hunger, thirst, and satisfaction scores were recorded for all patients. In the operating room, standard ASA monitoring was applied, and a uniform general anaesthesia technique was used, consisting of glycopyrrolate, midazolam, and fentanyl followed by induction with propofol and muscle relaxation with atracurium. Anaesthesia was maintained using sevoflurane. Hemodynamic parameters were monitored at baseline, after induction, every 2 minutes for the first 10 minutes, every 5 minutes until 30 minutes, and subsequently every 15 minutes until the end of surgery. At the conclusion of the procedure, standard reversal of neuromuscular blockade was administered.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients 18-65 years (either of sex) ASA grade I, II Patients willing to comply with standard preoperative fasting and oral carbohydrate loading protocols.
  • All patient undergoing elective ENT surgery under general anaesthesia.

排除标准

  • 未提供

研究者

发起方
D Y Patil University School of Medicine and Hospital Nerul Navi Mumbai
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Shashikumar D Mainale

padmashree d y patil school of medicine navi mumbai

研究点 (1)

Loading locations...

相似试验