跳至主要内容
临床试验/CTRI/2023/11/059539
CTRI/2023/11/059539已完成Phase 3 4

Comparison of two different techniques of sedation in children with complex cardiacdisease undergoing CT angiography; Prospective Randomised Study

Post Graduate Institute of Medical Education ResearchChandigarh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月15日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Scale of 2 between the two techniques (lap vs table).

研究概览

简要总结

For the study, two groups of patients will be taken. After a thorough pre-anaesthetic evaluation, confirming fasting status and obtaining parental consent, baseline vitals (HR, Oxygen saturation) will be recorded. Patients will be randomly allocated to one of two groups using computer-generated random numbers. Preoperative anxiety will be scored at 2 time points – in the preoperative holding area and at the time of administration off sedative, using the modified Yale Preoperative Anxiety Scale (mYPAS)16. Following this Group A children will be given a combination of midazolam 0.05 mg/kg, glycopyrrolate 0.01 mg/kg and ketamine 0.5 mg/kg iv in the mother’s lap inside the CT suite. Ketamine will be titrated every 30 seconds in steps of 0.25 mg/kg to achieve a Paediatric Sedation State Scale (PSSS) of 2. Group B children will also be given the same combination but after shifting the child inside the CT suite on the CT table. A maximum cumulative dose of 2 mg/kg of ketamine will be used during induction of sedation. If the child fails to achieve an PSSS of 2 at this maximum dose, the child will be excluded from the study and alternative sedatives will be used at the treating clinician’s discretion.

The total requirement of ketamine required for keeping the child sedated (PSSS of 2) child during the whole procedure will be recorded. If the child moves during the procedure or is agitated, it will be noted and an additional bolus of 0.25 mg/kg of ketamine will be given to achieve an PSSS of 2 in both the groups. The amount of bolus/number of boluses required will be recorded. Any episodes of desaturation (10% from baseline), cyanosis and apnea will be noted. After the procedure, the child will be shifted to the recovery room with oxygen and the time required to awaken the child will be noted.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Month(s) 至 3.00 Year(s)(—)
性别
All

入选标准

  • child with diagnosed complex cyanotic congenital heart disease (ASA III or IV) with baseline saturation less than 90 per cent requiring sedation for cardiac CT angiography.

排除标准

  • Acyanotic CHD
  • Older children >3 years
  • refusal of consent by parents
  • Active URI
  • Contraindication for contrast (CKD)
  • Contrast allergy
  • Full stomach children.

结局指标

主要结局

Scale of 2 between the two techniques (lap vs table).

时间窗: From the onset of the sedation process till the achievement of PSSS 2. up to 30 minutes.

To quantify the difference in dose of ketamine required to achieve a Pediatric Sedation State

时间窗: From the onset of the sedation process till the achievement of PSSS 2. up to 30 minutes.

次要结局

  • 1. To record any episodes of desaturation and bradycardia (reversal of shunt).(2. To record the total amount of ketamine required during the whole procedure.)

研究者

发起方
Post Graduate Institute of Medical Education ResearchChandigarh
申办方类型
Research institution and hospital

研究点 (1)

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