Clinical trial NCT06482125: Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia
Official title: Emergence Agitation in Pediatrics After Dexmedetomidine vs. Sevoflurane Anesthesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergence Delirium
Keywords: Emergence Agitation
Dexmedetomidine
Delirium
Children
Facial Cleft
Lead sponsor: Pelita Harapan University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 121
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pediatrics ages 3 months to 10 years
Primary purpose: PREVENTION

Brief summary: Emergence agitation is commonly encountered after receiving inhalation anesthesia. This distressing phenomenon carries risks that are harmful to patients, caregivers and medical personnel. Using total intravenous Dexmedetomidine, the investigators seek to reduce agitation and provide gentle emergence from anesthesia.

Detailed description: Surgery for pediatric cleft lip and palate repair often utilizes high dose opioids and inhaled anaesthesia, thereby causing postoperative complications such as desaturation and/or severe agitation after anesthesia. These complications are detrimental to the child, medical personnel and causes tremendous psychologic stress to parents. This study aims to decrease these complications through Dexmedetomidine, an Alpha-2 receptor agonist with anxiolytic, sympatholytic and analgetic properties. Devoid of respiratory depressant effect, it allows patients to maintain effective ventilation and reduce agitation, postoperatively. Its unique anesthetic property may shed light to provide safe anesthesia and gentle emergence to this young, vulnerable population.

Eligibility criteria: Inclusion Criteria:

1. Patients with weight ranging 5 kg - 25 kg
2. Patients with American Society of Anesthesiologist (ASA) Physical Status Classification 1 and 2

Exclusion Criteria:

1. Patients with any acquired congenital syndrome
2. Patients who are actively taking anti-seizure medications and/or has been diagnosed with epilepsy
3. Patients with functional and structural abnormalities of the heart, including arrythmias
4. Patients with liver disease

Primary outcomes:
measure: Emergence Agitation
timeFrame: Assessed starting the time of extubation and every 15 minutes interval until the patient is completely awake in the recovery room. The average of all values throughout the observation period was summed and the average scale reported.
measure: Duration of Anesthesia (Minutes)
timeFrame: From time of anesthesia induction up to the termination of anesthetic agent, assessed up to two hours.
measure: Duration of Surgery (Minutes)
timeFrame: From time of surgery up to the termination of anesthetic agent, assessed up to two hours.
Secondary outcomes:
measure: Time to Extubation (Minutes)
timeFrame: Maximum time to extubate was up to 26 minutes.
measure: Time to Full Recovery
timeFrame: Maximum time observed was up to 105 minutes.
Other outcomes:
Locations:
city: Tangerang
country: Indonesia
facility: Pelita Harapan University
state: Banten
Study officials:
affiliation: Pelita Harapan University
name: Hori Hariyanto, MD
role: STUDY_DIRECTOR
References:
citation: Liu D, Pan L, Gao Y, Liu J, Li F, Li X, Quan J, Huang C, Lian C. Efficaciousness of dexmedetomidine in children undergoing cleft lip and palate repair: a systematic review and meta-analysis. BMJ Open. 2021 Aug 16;11(8):e046798. doi: 10.1136/bmjopen-2020-046798.
citation: Peng W, Zhang T. Dexmedetomidine decreases the emergence agitation in infant patients undergoing cleft palate repair surgery after general anesthesia. BMC Anesthesiol. 2015 Oct 13;15:145. doi: 10.1186/s12871-015-0124-7.