Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia

May 9, 2025 updated by: Corry Quando Yahya, Pelita Harapan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Banten
      • Tangerang, Banten, Indonesia, 15811
        • Pelita Harapan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Intravenous Dexmedetomidine
Active Comparator: 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.
Drug: Sevoflurane
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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
From time of anesthesia induction up to the termination of anesthetic agent, assessed up to two hours.
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.
From time of surgery up to the termination of anesthetic agent, assessed up to two hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Maximum time to extubate was up to 26 minutes.
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.
Maximum time observed was up to 105 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pelita Harapan University

Investigators

  • Study Director: Hori Hariyanto, MD, Pelita Harapan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 183/K-LKJ/ETIK/V/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data and other supporting information will be available upon request.

IPD Sharing Time Frame

31 July 2024 up to 31 December 2024

IPD Sharing Access Criteria

Data may be accessed for audit purposes

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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