跳至主要内容
临床试验/CTRI/2024/11/076923
CTRI/2024/11/076923招募中不适用

Comparison of three scoring criteria to assess discharge from post anesthesia care unit in paediatric patients undergoing laparoscopic surgery under general anesthesia:An Observational Study

All India Institute of Medical Sciences AIIMS Jodhpur1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
270
试验地点
1
主要终点
To compare three criteria in terms of time taken for discharge from post anesthesia care unit in pediatric patients aged 1-18 years, undergoing elective laparoscopic surgeries under general anesthesia.

研究概览

简要总结

After receiving approval from the Institutional Ethical Committee and registration in CTRI, Children who satisfy the specified criteria will be chosen to take part in the study. Written and informed consent will be mandatory from the parents/guardians of patients who are taking part in the study. Assent will be acquired from children who are above the age of seven. A thorough preoperative assessment will be performed the day before the procedure. Younger children will get premedication consisting of Inj. Midazolam and Inj. Ketamine as per the Institutional protocol. The child will be administered IV Fentanyl and IV Propofol as per the Institutional protocol for induction. The initiation of neuromuscular paralysis will be achieved using either Inj. Atracurium or Inj. Rocuronium, based on the discretion of the overseeing anesthesiologist. The maintenance of anaesthesia will be accomplished by utilising a mixture of oxygen and sevoflurane. The reversal of the neuromuscular blockade will be accomplished with intravenous administration of Neostigmine and Glycopyrrolate. The child will be relocated to the Post-Anesthesia Care Unit (PACU). Every patient will be assessed for the time taken to discharge from the Post-Anesthesia Care Unit (PACU) using all the three scores. The time duration required to attain a score of ≥9 in the Modified Aldrete score, ≥9 in the Modified postanesthetic discharge score, and ≥12 in the White’s fast-track score will be documented. The quantity of opioids and antiemetics administered throughout the perioperative period will be documented. All adverse complications will be recorded in the Post-Anesthesia Care Unit (PACU) and 24 hours after being discharged from the PACU.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Pediatric patients belonging to the group of ASA I/II and in the age group of 1-18 years scheduled to undergo elective laparoscopic surgeries under general anaesthesia with duration less than 2 hours.

排除标准

  • Patients undergoing emergency surgeries.
  • Patients having preoperative hemodynamic instability.

结局指标

主要结局

To compare three criteria in terms of time taken for discharge from post anesthesia care unit in pediatric patients aged 1-18 years, undergoing elective laparoscopic surgeries under general anesthesia.

时间窗: At baseline

次要结局

  • To assess:(1.Any complications during PACU stay.)

研究者

发起方
All India Institute of Medical Sciences AIIMS Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sayanta Das

All India Institute of Medical Sciences (AIIMS), Jodhpur

研究点 (1)

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