Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pediatrics ages 3 months to 10 years

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Patients are selected randomly using a computer-generated device to become a control arm or a treatment arm

Study Groups

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Inhalation Sevoflurane

Participants in this group will receive inhalation anesthesia Sevoflurane at 2-3 Vol% as their sole anesthetic maintenance agent throughout the surgical procedure.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Inhalation Sevoflurane will be administered as an anesthetic maintenance agent. Sevoflurane at 2 - 3 Vol% will be administered throughout the operative procedure.

Total Intravenous Dexmedetomidine

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Intervention group will receive Total Intravenous Dexmedetomidine as their anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour continued as the sole anesthetic maintenance agent, thereafter.

Interventions

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Dexmedetomidine

Intervention group will receive Total Intravenous Dexmedetomidine as their anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour continued as the sole anesthetic maintenance agent, thereafter.

Intervention Type DRUG

Sevoflurane

Inhalation Sevoflurane will be administered as an anesthetic maintenance agent. Sevoflurane at 2 - 3 Vol% will be administered throughout the operative procedure.

Intervention Type DRUG

Other Intervention Names

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Intravenous Dexmedetomidine Inhalation Sevoflurane

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes