study the effect of dexmedetomidine drug in preventing confusional state and agitation that occurs in patients undergoing brain surgery under general anaesthesia.
- Conditions
- Other intraoperative and postprocedural complications and disorders of nervous system,
- Registration Number
- CTRI/2021/11/037735
- Lead Sponsor
- Institutional Review BoardChristian Medical CollegeVellore
- Brief Summary
Emergenceagitationand delirium are well-described phenomena during emergence from generalanaesthesia, especially in the paediatric population.
EmergenceAgitation (EA) is an “unpleasant state of extreme arousal†characterized bynon-purposeful movement, restlessness, thrashing, incoherence, inconsolability,and unresponsiveness usually following emergence from General Anaesthesia. Thetrue incidence of EA in children is unclear but has been estimated to bebetween 10 - 80 %.
EmergenceDelirium (ED) is an altered state ofconsciousness, which begins with emergence from anesthesia and continuesthroughout the early recovery period. ED is a disturbance of awareness of, orattention to, the child’s environment, and manifests as disorientation,hyperactive/hypoactive behavior, and hypersensitivity in the immediate periodafter anesthesia.
Althoughthere is significant ongoing research on the incidence, risk factors, and theprobable consequences of EA/ED, neurosurgical procedures have generally beenexempt owing to the complexity in differentiation between the neurologicalconditions and the effect of recovery from anaesthetics. A study done in the adult neurosurgical populationhas shown a higher incidence of EA in neurosurgical patients (29%).
Childrenundergoing craniotomy are more vulnerable to the stress that follows EA/ED. Ina recent observational study done in our institution, the incidence of emergenceagitation was 28% in the paediatric population undergoing craniotomy.
Total intravenousanaesthetic (TIVA) techniques with propofol, which has been the mainstay of neurosurgicalpractice have been associated with a reduced incidence of EA/ED in othersurgical procedures. However, in children, it is often necessary to use highconcentration volatile anaesthetics to induce general anaesthesia beforeinitiation of TIVA as they may not cooperate for intravenous access whichpredisposes them to develop EA/ED.
Dexmedetomidineis a selective alpha-2 receptor agonist acting on alpha-2receptors in the locus ceruleous of the pons. Recently, Dexmedetomidine isbeneficial in reducing the incidence of EA/ED in children undergoing generalanaesthesia. However, there is no literature regarding its use in thepaediatric neurosurgical population.
We hypothesizethat the use of intravenous dexmedetomidine as an infusion at a dose of0.5mcg/kg/hr could reduce the incidence of EA/ED in paediatric patientsundergoing craniotomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 80
ASA 1 and 2 Paediatric age group patients planned for craniotomy under general anaesthesia will be recruited for the study.
- 1)ASA 3 and above.
- 2)Known allergy to study drugs.
- 3)History of renal disease-age appropriate e-GFR criteria 4)History of liver disease.
- 5)Psychiatric illness 6)Heart block, known case of seizure disorder coming for seizure surgery 7)Patient refusal 8)GCS <15.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Emergence Delirium as assessed by the PAED scale 7 time points,T1-at recovery,T2 after 2 hours of recovery,T3-6 hours,T4-12 hours,T5-24 hours,T6- 36 hours,T7-48 hours
- Secondary Outcome Measures
Name Time Method 1)Emergence Agitation as assessed by Watcha, Richmond’s agitation sedation scale 2.Intraoperative and Postoperative haemodynamics
Trial Locations
- Locations (1)
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Christian Medical College🇮🇳Vellore, TAMIL NADU, IndiaDrAjisheen BorgeoPrincipal investigator9995927960sheenborgeo@gmail.com