跳至主要内容
临床试验/CTRI/2025/10/096495
CTRI/2025/10/096495尚未招募不适用

A Prospective Observational Study to Assess the Quality of Recovery in Children Undergoing Elective Day Care Surgeries in a Tertiary Care Hospital in India

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月16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
150
试验地点
1
主要终点
mean total score on the Pediatric Scale for Quality of Recovery (PedSQoR) assessed at 2–4 hours after surgery

研究概览

简要总结

This is a single-arm, prospective, cross-sectional observational study conducted at a tertiary care hospital in India to evaluate the early quality of recovery in children undergoing elective day care surgery. Eligible patients aged 2–18 years will be recruited preoperatively, and baseline demographic and clinical data will be recorded. Postoperative recovery will be assessed 2–4 hours after surgery using the validated Pediatric Scale for Quality of Recovery (PedSQoR), along with a parental satisfaction survey. Associations between recovery scores and surgical/anesthetic variables will be explored, and early postoperative complications such as vomiting, agitation, and delayed feeding will be documented. The findings aim to provide evidence to refine discharge criteria and improve perioperative care for pediatric day care surgery in the Indian context.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Children aged 2–12 years of either gender 2)Scheduled for elective day care surgery.
  • Patients belonging to American Society of Anaesthesiologists’ Physical Status Grade I or II 4)Guardians giving wilful consent for the participation in the study.

排除标准

  • Developmental delay or cognitive impairment.
  • Emergency surgeries.
  • Patient/Guardian refusal.

结局指标

主要结局

mean total score on the Pediatric Scale for Quality of Recovery (PedSQoR) assessed at 2–4 hours after surgery

时间窗: at 2 hrs and 4 hrs post surgery

次要结局

  • • To assess associations between demographic/clinical factors (age, type of surgery, duration, ASA status) and PedSQoR scores(• To evaluate parental satisfaction at 2-4 hours post-discharge)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sushmita Bairagi

AIIMS,New Delhi

研究点 (1)

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