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临床试验/CTRI/2023/08/057140
CTRI/2023/08/057140尚未招募不适用

Does a change in optic nerve sheath diameter have an association with postoperative emergence delirium in paediatric patients undergoing laparoscopic surgeries? : An observational study

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2023年9月15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
103
试验地点
1
主要终点
To determine the association between the intraoperative change in optic nerve sheath diameter(ONSD) & postoperative emergence delirium in paediatric patients undergoing laparoscopic surgeries

研究概览

简要总结

In the laparoscopic surgeries, the carboperitoneum created causes an increase in the intracranial pressure. Optic nerve sheath diameter measurement is a simple bedside tool which can be used as a surrogate for an increased intracranial pressure. There are studies in adult population showing the correlation between

increased optic nerve sheath diameter intraoperatively and inadequate postoperative awakening; but no such studies exist in paediatric population.

PRIMARY OBJECTIVE:

To determine the association between the intraoperative change in optic nerve sheath diameter (ONSD) and postoperative emergence delirium in paediatric patients undergoing laparoscopic surgeries

SECONDARY OBJECTIVES:

To correlate ONSD with postoperative emergence delirium score in patients with postoperative emergence delirium.To correlate ONSD with postoperative nausea vomiting and to correlate postoperative emergence delirium with preoperative patient anxiety

Sample size: 103 patients

Inclusion criteria

  1. Age 2 to 8 years

  2. ASA physical status I/II

  3. Patients undergoing various laparoscopic surgeries under general anaesthesia

  4. Cognitively intact children

Exclusion criteria

  1. Parental /guardian refusal for inclusion in the study

  2. Patients with age < 2 years and >8 years

  3. History of eye surgery

  4. Current eyeball/orbit disease (e.g., cataract, glaucoma, retinal detachment)

  5. Increased intracranial pressure (e.g., brain tumour, spinal cord lesion)

  6. Seizure disorder, developmental disorder, psychiatric illness

  7. History of adverse reaction to ultrasound gel or Tegaderm

  8. ASA grade III/IV

On arrival of the patient to the operating room,  standard ASA monitoring will be employed.  General anaesthesia will be given to the patient. Ultrasonographic Measurement of Optic Nerve Sheath Diameter will be measured at three specific timepoints. T1, immediately after the induction of anaesthesia; T2, 15 minutes after intraperitoneal CO2 insufflation and T3, 10 min after releasing the pneumoperitoneum. In the PACU, the ED will be assessed on arrival to PACU and at each 5-minute interval till 30 minutes from the time of awakening and whenever the child becomes agitated. Postoperative nausea and vomiting will be assessed on a 4 point objective score till 3o minutes after the surgery.  The modified Yale preoperative anxiety scale will be used to assess preoperative anxiety in the preoperative holding area 30 minutes prior to surgery.

We hypothesize that in paediatric patients undergoing laparoscopic surgeries an intraoperative change of optic nerve sheath diameter will have an association with postoperative emergence delirium.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients aged 2-8 years
  • ASA physical status I/II
  • Patients undergoing laparoscopic surgeries under general anaesthesia
  • Cognitively intact children.

排除标准

  • Parent/ guardian refusal for inclusion in the study
  • Patients with age <2years and >8years
  • History of eye surgery
  • Current eyeball/orbit disease
  • Increased intracranial pressure
  • Seizure disorder, developmental disorder, psychiatric illness
  • History of adverse reaction to ultrasound gel or Tegaderm
  • ASA grade III/IV.

结局指标

主要结局

To determine the association between the intraoperative change in optic nerve sheath diameter(ONSD) & postoperative emergence delirium in paediatric patients undergoing laparoscopic surgeries

时间窗: On table and at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes after spontaneous eye opening.

次要结局

  • 1.To correlate ONSD with postoperative emergence delirium score in patients with postoperative emergence delirium(2.To correlate ONSD with postoperative nausea vomiting)

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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