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临床试验/CTRI/2018/03/012807
CTRI/2018/03/012807已完成4 期

A Comparative Study of Intranasal Dexmedetomidine and Intranasal Midazolam as Premedication in Children Undergoing Short Surgical Procedures

Principle Investigator1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2016年1月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
104
试验地点
1
主要终点
Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S).

研究概览

简要总结

SUMMARY

This study was conducted in thedepartment of anesthesiology and critical care at the pediatric surgeryoperating theatre complex, St. John’s Medical College Hospital, Bangalore.

In this study, 104 ASA grade I andII children between 2-10 years, who were scheduled for elective surgicalprocedures were observed. The patients that received intranasal Dexmedatomidine(1µg/kg) were allotted to group D and the patients that received intranasalMidazolam (0.2mg/kg) were put under group M.

30 minutes after premedication withthe intranasal drug, the Parental Separation Anxiety Score was assessed on a 4point scale and sedation of the child was assessed using a 6 point ModifiedObserver’s Assessment of Alertness/Sedation Scale. Prior to anesthesiainduction the Mask Acceptance Score was assessed using a 5 point scale.

There was a marked variation betweenthe two groups with regards to the parental separation. There was astatistically significant data which concluded the children premedicated withintranasal Dexmedetomidine separated much more easily than those premedicatedwith intranasal Midazolam.

The Modified Observer’s Assessmentof Alertness/Sedation scores showed a significantly better score in theDexmedetomidine group compared to Midazolam, indicating a better degree ofsedation among those premedicated with Dexmedetomidine.

There was a statisticallysignificant difference with respect to mask acceptance before induction ofanesthesia. The patients premedicated with intranasal Dexmedetomidine had bettermask acceptance compared to those premedicated with intranasal Midazolam.

The demographic data recorded foundno difference in the age or gender between the two groups.

After premedication the childrenwere monitored for 30 minutes at every 10 minute interval, prior to inductionof anesthesia. Vital signs (heart rate, BP, respiratory rate and oxygensaturation) were recorded. After administering intranasal premedication it wasfound the there was a fall in heart rate, without significant fall in bloodpressure in the patients who were administered Dexmedetomidine. There was nochange in the respiratory rate or oxygen saturation.

Intra-operatively, the vitals weremonitored every 5 minute interval for 30 minutes and thereafter every 10minutes till the end of the procedure. The intra-operative period showed nosignificant variation in the vital parameters between the two groups.

Postoperatively the children were monitored for 24 hours after the procedure. Thevitals were stable and there were no adverse reactions in any of the children.

Therefore, based on these resultsit can be concluded that intranasal Dexmedetomidine (1 µg/kg) is moreefficacious than intranasal Midazolam (0.2 mg/kg) for premedicatingchildren undergoing short elective surgical procedures.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children aged 2-10 years undergoing minor surgical procedures under general anaesthesia American Society of Anaestheiologists (ASA) Physical Status I & II grade of patients.

排除标准

  • Parent refusal Known allergy to the drugs under study.
  • Cardiac dysrhythmias and/or congenital heart disease Psychotropic medication use Mental retardation Nasal disorders interfering with administration of medication as recurrent nasal bleeding or nasal masses.
  • Children who spat or refused intranasal administration of medication.

结局指标

主要结局

Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S).

时间窗: Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S). 30 minutes. | Parental Separation Anxiety scale (PSAS). 30 minutes. | Mask Acceptance Score(MAS). 30 minutes.

Mask Acceptance Score(MAS).

时间窗: Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S). 30 minutes. | Parental Separation Anxiety scale (PSAS). 30 minutes. | Mask Acceptance Score(MAS). 30 minutes.

Parental Separation Anxiety scale (PSAS).

时间窗: Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S). 30 minutes. | Parental Separation Anxiety scale (PSAS). 30 minutes. | Mask Acceptance Score(MAS). 30 minutes.

次要结局

  • pulse rate, BP, respiratory rate and oxygen saturation were recorded every 10 minute interval for 30 minutes from the time of extubation(pulse rate, BP, respiratory rate and oxygen saturation were recorded every 10 minute interval for 30 minutes from the time of extubation)

研究者

发起方
Principle Investigator
申办方类型
Other [self]

研究点 (1)

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