COMPARISON OF EFFECT OF DEXMEDETOMIDINE AS BOLUS OR LOW-DOSE INFUSION FOR THE PREVENTION OF EMERGENCE AGITATION UNDER SEVOFLURANE ANAESTHESIA IN PAEDIATRIC PATIENTS
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 76
- Locations
- 1
Study Overview
Brief Summary
Emergence agitation EA is a common problem seen in children after they recover from sevoflurane anesthesia with reported rates ranging from 10 to 80 percent It is characterized by restlessness crying confusion and uncontrolled body movements during recovery Although it usually settles on its own EA can cause issues such as self injury bleeding accidental removal of intravenous lines and a longer stay in the post anesthesia care unit PACU
The exact causes of EA are complex and involve several factors including postoperative pain rapid awakening in an unfamiliar environment anxiety and sometimes low oxygen levels Sevoflurane is a widely used inhalational anesthetic because it allows quick induction smooth maintenance and stable heart function However compared to agents like halothane or propofol it has a higher risk of causing EA
To prevent EA different drugs have been tried including propofol midazolam ketamine and alpha two adrenergic agonists such as clonidine and dexmedetomidine Among these dexmedetomidine has shown special promise because of its calming pain relieving and anti anxiety properties It has been proven to reduce both the occurrence of EA and the need for pain relieving opioids However there is still uncertainty about the best dose to use Higher doses of 0 point 5 micrograms per kilogram or more are effective but can cause side effects like slow heart rate low blood pressure and delayed removal of the breathing tube Lower doses between 0 point 2 and 0 point 4 micrograms per kilogram may offer a safer balance between effectiveness and stable vital signs
Previous research has used both single bolus doses and continuous infusions of dexmedetomidine with mixed results A meta analysis has confirmed its benefit in preventing EA though it may slightly delay recovery from anesthesia and PACU discharge Because there is no clear agreement on the most effective dose or method this study aims to compare dexmedetomidine given as a single bolus versus a low dose infusion for preventing emergence agitation in children
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA classification I-II
- •Age between 2-12 years
- •Undergoing lower abdominal surgery like (Hernia Repair, Orchidopexy, Meckel’s Diverticulectomy, Circumcision, Anorectal malformation repair) with sevoflurane anaesthesia.
Exclusion Criteria
- •No consent
- •Developmental delay.
- •Congenital airway or cardiac disorders.
- •History of allergy to study medications.
- •Psychological disorders, epilepsy.
Investigators
Tarun shekhar
Armed forces medical college