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NCT Number: NCT06482125

Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia

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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Key information

Conditions

Emergence Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pelita Harapan University

Tangerang, Banten, 15811, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Dexmedetomidine

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.

Other names: Intravenous Dexmedetomidine

Sevoflurane

Drug

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

Other names: Inhalation Sevoflurane

Primary outcomes

  1. Emergence Agitation

    Time frame: 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.

    Cravero scale uses a numeric scale. 1 = obtunded with no response to stimulation; 2 = asleep, but responsive to movement or stimuli; 3 = awake and responsive, 4 = crying; 5 = thrashing behavior that requires restraint. Minimum values of NOT AGITATED is 1.0 up to maximum of 2.9. Minimum values of AGITATED is 3.10 up to maximum of 5.0. Cravero scale is measured from the moment of extubation and every 15 minutes thereafter until the patient is completely awakened (in the recovery room). The total score is summed, and the average is reported.

  2. Duration of Anesthesia (Minutes)

    Time frame: From time of anesthesia induction up to the termination of anesthetic agent, assessed up to two hours.

    Measures the time of anesthesia (in minutes) starting from induction of anesthesia to the termination of anesthetic agent

  3. Duration of Surgery (Minutes)

    Time frame: From time of surgery up to the termination of anesthetic agent, assessed up to two hours.

    Measures the time of surgery after the application of sterile draping up to the end of surgery.

Secondary outcomes

  1. Time to Extubation (Minutes)

    Time frame: Maximum time to extubate was up to 26 minutes.

    Measures the amount of time taken to extubate. Time is recorded from the moment Sevoflurane is stopped or Dexmedetomidine infusion is stopped until the patient is fit to extubated.

  2. Time to Full Recovery

    Time frame: Maximum time observed was up to 105 minutes.

    Measures amount of time taken to full awakening. Time is recorded from the moment of extubation until patient completely awaken at the recovery room area.

Sponsors and collaborators

Lead sponsor

Pelita Harapan University

Other

Registry information

Official study title

Emergence Agitation in Pediatrics After Dexmedetomidine vs. Sevoflurane Anesthesia: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2024
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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