Emergence Agitation is a Problem in Pediatric Anesthesia. We Aim to Lower Its Incidence by Using Dexmedetomidine

Pelita Harapan University

Status: Enrolling

Conditions: Emergence Delirium

Treatments: Drug: Inhalation Sevoflurane; Drug: Total Intravenous Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06482125

183/K-LKJ/ETIK/V/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 3 months to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Inhalation Sevoflurane

Active Comparator group

Description:

Participants in this group will receive inhalation anesthesia Sevoflurane at 2-2.5 Vol% as their sole anesthetic maintenance agent throughout the surgical procedure.

Treatment:

Drug: Inhalation Sevoflurane

Total Intravenous Dexmedetomidine

Experimental group

Description:

Participants in this group will receive Total Intravenous Dexmedetomidine as their sole anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour will be given throughout the surgical procedure.

Treatment:

Drug: Total Intravenous Dexmedetomidine