Clinical trial NCT05813106: Intravenous Dexmedetomidine for Emergence Delirium in Pediatric Patient
Official title: Effect of Fixed Dose Intravenous Dexmedetomidine on Emergence Delirium After General Anesthesia for a Surgery in Pediatric Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Emergence Delirium
Dexmeditomidine
Keywords: emergence delirium, dexmeditomidine, pediatric patients
Lead sponsor: Security Forces Hospital
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups One group will receive IV dexmedetomidine Other control group receive normal saline
Primary purpose: PREVENTION

Brief summary: Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol, fentanyl, ketamine, clonidine, midazolam and dexmedetomidine etc (5). Dexmedetomidine is a potent highly selective alpha-2 agonist. Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression (6). It has been used as continuous infusion or as fixed dose in the range between 0.15 mcg/kg to 2 mcg/kg to prevent ED in children (7, 8, 9). Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay (9) while lower doses were not as effective (7). The aim of this study was to investigate the role of fixed dose of 0.2 mcg/kg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia.

Detailed description: Emergence delirium (ED) is an altered state of consciousness that usually occurs within 45 minutes after cessation of anesthesia. It typically presents as disorientation, averted eyes or staring, psychomotor agitation and non-purposeful, resistive movements like pulling, kicking or flailing (1, 2). ED can result in potential risk of bodily harm to patient or healthcare staffs, prolonged PACU (post-anesthesia care unit) stay and postoperative maladaptive changes including temper tantrums, attention seeking, sleep alterations and bed wetting in children (2).

Risk factors for ED include preoperative anxiety and confusion, psychological immaturity and use of various medications peri-operatively (2, 3). The incidence of ED varies by age of patient, anesthesia technique, type of surgeries, pain and also by choice of tool to diagnose ED. It occurs two to three more commonly in children as compared to adults. Scientific literature suggest the incidence of ED in the range between 20 -80 % in pediatric anesthesia practice (4).

Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol, fentanyl, ketamine, clonidine, midazolam and dexmedetomidine etc (5). Dexmedetomidine is a potent highly selective alpha-2 agonist. Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression (6). It has been used as continuous infusion or as fixed dose in the range between 0.15 mcg/kg to 2 mcg/kg to prevent ED in children (7, 8, 9). Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay (9) while lower doses were not as effective (7). The aim of this study was to investigate the role of fixed dose of 0.2 mcg/kg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 2 and 12 years, scheduled to undergo general anesthesia for a surgery with an ASA score of 1 to 3 will be included in the study.

Exclusion Criteria:

* Parents who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with known allergy to dexmedetomidine, psychiatric disorders or use of psychiatric medications will not be included in the study

Primary outcomes:
measure: Emergence delirium
timeFrame: up to 120 minutes
Secondary outcomes:
measure: Pain score
timeFrame: every 15 minutes upto discharge from PACU maximum 120 minutes
measure: Opioid consumption
timeFrame: upto discharge from PACU maximum 120 minutes
measure: Side effects
timeFrame: PACU stay maximum 120 minutes
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Security Forces Hospital
Study officials:
affiliation: Security Forces Hospital
name: Anwar ul Huda, FRCA
role: PRINCIPAL_INVESTIGATOR
References: