A Phase 4 interventional study of Dexmedetomidine in Anxiety, Separation, sponsored by The University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 6 Months to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-18.
Sponsored by The University of Hong Kong · Phase 4, Interventional, and Treatment
The purpose of the study is to determine if 4mcg/kg of intranasal dexmedetomidine is better than 2mcg/kg in successfully sedating a child prior to induction of anesthesia.
Dexmedetomidine is a selective alpha-2 adrenoreceptor agonist that has sedative, anxiolytic and analgesic properties without causing respiratory depression. It has been administered safely and effectively via a number of routes including as an intravenous infusion, intramuscularly, intranasally, buccally and orally .
Yuen et al established that the median time of onset of sedation is 25-30 minutes, making it an ideal agent for preoperative sedation. The same group also studied doses of 1 mcg/kg and 2 mcg/kg as a sedative premedication and found that the success rates of appropriate sedation at induction in children aged 1 to 8 years were 53% and 66% respectively, with a dose related increase in successful sedation.
Much higher doses of dexmedetomidine have also been used safely. Administered intravenously, 3mcg/kg of dexmedetomidine has been shown to provide satisfactory sedation for paediatric MRI in 97% of cases, without adverse effects.
The investigators aim to show that high dose intranasal dexmedetomidine is a safe, effective and an easily administered sedative premedication.
The investigators hypothesise that 4mcg/kg compared to 2mcg/kg of intranasal dexmedetomidine will lead to at least a 20% increase in the proportion of satisfactorily sedated patients at the time of anaesthesia induction.
The primary outcome will be the proportion of children with satisfactory sedation at the time of anaesthesia induction.
Suitable patients will be identified from the theatre lists and consent will be sought from their legal guardians during preassessment clinic or during their anaesthetic preoperative assessment on the ward.
In a previous study, 66% of children aged 1-5 years were satisfactorily sedated at the time of induction with 2 mcg/kg of intranasal dexmedetomidine. In order to find a 20% difference with 4 mcg/kg of dexmedetomidine, the investigators' sample size needs to be 140 (70 in each group), for a power of 0.8 and a 5% false positive rate.
The demographic data will be analysed by t test and chi-square test. The proportions of satisfactory sedation will be analysed by chi-square test. The onset sedation time and duration of sedation will be analysed by survival analysis. The vital signs over times will be expressed by percentage changes from baseline and estimated by mean and standard errors. A p-value\<0.05 will be considered statistically significant.
59 studies on the registry are indexed under Anxiety, Separation; 5 are open to participants now.
This study's planned enrollment of 140 is above the median of 68 across 53 interventional studies indexed under Anxiety, Separation.
Browse Anxiety, Separation studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction
Drug: Dexmedetomidine
4 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction
Drug: Dexmedetomidine
Either 2mcg/kg or 4mcg/kg of intranasal dexmedetomidine will be given to assess efficacy of preoperative sedation
Also known as: Precedex
Satisfactory sedation
The primary outcome will be the proportion of children with satisfactory sedation at the time of anaesthesic induction.
Time frame: From 30 minutes post drug administration to induction of anaesthesia (average 30 minutes)
Time to satisfactory sedation
Time taken from drug administration to when the child's sedation level is that of only responding after mild prodding or shaking
Time frame: From time of drug administration to when Observer's Assessment of Alertness/ Sedation Score is 2 or less (from 0 minutes to 30 minutes)
Blood pressure
Blood pressure will be taken every 5 minutes
Time frame: From drug administration to end of anaesthesia (on average 1 to 3 hours)
Heart rate
Heart rate will be taken every 5 minutes
Time frame: From drug administration to end of anaesthesia (on average 1 to 3 hours)
Oxygen saturations
Oxygen saturations will be taken every 5 minutes
Time frame: From drug administration to end of anaesthesia (on average 1 to 3 hours)
The record gives a start of Jun 2015, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine