Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia

NCT06482125 | Completed Results

• 1 other identifier: 183/K-LKJ/ETIK/V/2024
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium

Keywords

Emergence Agitation; Dexmedetomidine; Delirium; Children; Facial Cleft

Outcome Measures

Primary Outcomes (3)

• Emergence Agitation

  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.

  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.

• Duration of Anesthesia (Minutes)

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

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

• Duration of Surgery (Minutes)

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

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

Secondary Outcomes (2)

• Time to Extubation (Minutes)

  Maximum time to extubate was up to 26 minutes.

• Time to Full Recovery

  Maximum time observed was up to 105 minutes.

Study Arms (2)

Inhalation Sevoflurane

ACTIVE COMPARATOR

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

Drug: Sevoflurane

Total Intravenous Dexmedetomidine

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Interventions

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.

Also known as: Intravenous Dexmedetomidine

Total 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.

Also known as: Inhalation Sevoflurane

Inhalation Sevoflurane

Eligibility Criteria

• Age: 3 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pelita Harapan University: lead

Study Sites (1)

Pelita Harapan University

Tangerang, Banten, 15811, Indonesia

Location

Related Publications (2)

• 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.

  PMID: 34400450 RESULT

• 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.

  PMID: 26464000 RESULT

MeSH Terms

Conditions

Emergence Delirium; Delirium

Interventions

Dexmedetomidine; Sevoflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Results Point of Contact

• Title: Dr. Corry Quando Yahya
• Organization: Universitas Pelita Harapan

corry.yahya@lecturer.uph.edu

2181383190900

Study Officials

• Hori Hariyanto, MD

  Pelita Harapan University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are selected randomly using a computer-generated device to become a control arm or a treatment arm
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Anesthesiologist and Lecturer at Pelita Harapan University, Department of Anesthesia and Intensive Care

Model Details: Pediatrics ages 3 months to 10 years

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: July 31, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 31 July 2024 up to 31 December 2024
• Access Criteria: Data may be accessed for audit purposes

Locations

ID (1)