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临床试验/NCT05766436
NCT05766436招募中不适用

Nebulized Dexmedetomidine VS Oro-dispersible Film Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Outpatient Surgeries: A Randomized Controlled Double-blinded Study

nada moahmed aboelrouse1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
perioperative anxiety

研究概览

简要总结

The goal of this clinical trial is to compare between the effect of nebulized dexmedetomidine and the effect of oral dispensable film (ODF) melatonin in controlling perioperative anxiety and post operative emergence agitation and their effect on the overall surgical experience.in pediatric patients undergoing day case surgery.

详细描述

All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs will be recorded. According to randomization that will be done by envelop concealed allocation , the drug will be administered to the patients by a researcher who will not participate in the evaluation of the patients 30 mins before transfer to the operation room (OR): each group will receive the intervention drug Parents are not allowed to accompany their children to the OR according to the hospital policy. On arrival to the OR department the Parental separation anxiety scale (PSAS) will be calculated on entering the operation room standard monitoring will be commenced including ECG, non-invasive blood pressure and pulse oximetry and baseline measurement will be recorded. Inhalational induction will be then started with sevoflurane and mask acceptance will be calculated according to the mask acceptance scale (MAS) intravenous cannulation will be then established after which each patient will receive 1-2 mg/kg Propofol, 1 µg/kg fentanyl to attenuate the stress of intubation and 0.5mg/kg atracurium after tracheal intubation anesthesia will be maintained with sevoflurane 2-4 MAC During the length of the operation vital data will be recorded at 5 minutes interval. all patients will receive IV paracetamol 15mg/kg and patient would receive 1 µg/kg fentanyl as a rescue dose if vital data increased by >20% of the baseline.

after the completion of surgery extubating will be performed after meeting extubation criteria and patient will be discharged to post-anesthesia care unit (PACU) in for the first 15 min after admission to PACU the post anesthesia emergence agitation will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED) during the stay in PACU pain will also be assessed by using FLACC score Discharge from PACU will be done after meeting discharge criteria and the time of discharge will be documented. After discharge pain score will be measured using FLACC score at 15, 30, 60 minutes interval postoperative and the total combustion of postoperative analgesics will be calculated as well as the time of discharge from the hospital

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients of American Society of Anesthesiologists (ASA) physical status I & II
  • both genders,
  • ≥ 2 to 10 years,
  • scheduled for elective day case surgery under general anesthesia

排除标准

  • parents' refusal for participation in the study
  • ASA III and VI patients with history of chronic illness
  • runny nose or upper respiratory tract infection
  • Emergency surgeries with hemodynamic instability
  • history of allergic reaction to dexmedetomidine or melatonin
  • History of prematurity
  • developmental delay
  • central nervous system disorder,
  • mental retardation,
  • neurological or psychiatric illness that may be associated with anxiety and agitation (cerebral palsy, seizure, separation anxiety disorder, ADHD etc.).
  • treatment with anticonvulsants and sedatives

研究组 & 干预措施

group D

Active Comparator

will receive placebo ODF and nebulized dexmedetomidine (Precedex™ rxlist)

干预措施: Dexmedetomidine (Drug)

group M

Active Comparator

will receive placebo nebulizer and ODF melatonin (metacyst ™ nerhadou)

干预措施: Melatonin (Drug)

group C

Placebo Comparator

will receive placebo ODF and placebo 0.9% normal saline nebulizer

干预措施: Placebo (Drug)

结局指标

主要结局

perioperative anxiety

时间窗: during the patient separation from the caregiver just as the child is going to the operating theater

perioperative anxiety will be measured by using Parental separation anxiety scale (PSAS) will be calculated according to the following: * Behavior of the child during separation from parents will be Excellent if the Patient unafraid, cooperative, or asleep will be given the score of (1) * Behavior of the child during separation from parents will be Good if the patient is Slightly afraid/crying, quiet with reassurance will be given the score (2) * Behavior of the child during separation from parents will be Fair if the patient is Moderately afraid and crying not quit with reassurance with the score (3) * Behavior of the child during separation from parents will be poor if the patient is Crying, need for restraint with the score (4) the score of (1) means excellent response , score of (2) means good response , score of (3) means fair response and score of (4) means poor response

次要结局

  • mask acceptance(during the mask introduction to start inhalational induction of anesthesia with sevoflurane before skin incision)
  • post anesthesia emergence agitation(first 15 minutes after admission to post- anesthesia care unit)
  • pain score(during hospital stay up to 3 hours)

研究者

发起方
nada moahmed aboelrouse
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

nada moahmed aboelrouse

assistant lecturer

NewGiza University

研究点 (1)

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