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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Extubation (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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hori Hariyanto, MD | Pelita Harapan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pelita Harapan University | Tangerang | Banten | 15811 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34400450 | Result | 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. | |
| 26464000 | 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. |
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Individual participant data and other supporting information will be available upon request.
31 July 2024 up to 31 December 2024
Data may be accessed for audit purposes
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Inclusion criteria were: American Society of Anesthesiologists (ASA) physical status I or II patients, weighing not more than 25 kg were scheduled to undergo cleft lip or palate repair.
Exclusion criteria were children with congenital heart disease; syndromic children, and/or children with a history of epilepsy and liver dysfunction.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Inhalation Sevoflurane: Inhalation Sevoflurane will be administered as an anesthetic maintenance agent. Sevoflurane at 2 - 3 Vol% will be administered throughout the operative procedure. |
| FG001 | 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. Total Intravenous 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhalation Sevoflurane | Subjects receiving Sevoflurane as their maintenance anesthetic |
| BG001 | Total Intravenous Dexmedetomidine | Subjects receiving Dexmedetomidine as their maintenance anesthetic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is measured from the subject's birth date up to the date of surgery (in months). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Scale of 1.0 - 2.9 indicates no emergence agitation, a scale of 3.0 - 5.0 indicates emergence agitation | Posted | Mean | Standard Deviation | Score on a scale | 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. |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhalation Sevoflurane | Adverse events such as hypotension, bradycardia, cardiac arrest or admission to intensive care unit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Corry Quando Yahya | Universitas Pelita Harapan | 2181383190900 | corry.yahya@lecturer.uph.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2024 | Apr 22, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2024 | Apr 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Pediatrics ages 3 months to 10 years
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Patients are selected randomly using a computer-generated device to become a control arm or a treatment arm
|
|
| Sevoflurane | Drug | Inhalation Sevoflurane will be administered as an anesthetic maintenance agent. Sevoflurane at 2 - 3 Vol% will be administered throughout the operative procedure. |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Full Range |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight (kg) | Mean | Standard Deviation | kilogram |
|
| Type of operation (Labioplasty/Palatoplasty) | Count of Participants | Participants |
|
| Preschool Children | Ages Two to Five years old | Measures preschool children ages only 2 to 5 years old, population at high risk to experience emergence agitation | Mean | Standard Deviation | years |
|
| Modified Yale Preoperative Anxiety Scale (mYPAS) | Patients were assessed at the preoperative clinic one day before their surgery. mYPAS is an observational instrument that covers 4 items is the current "criterion standard" for assessing child anxiety. Scoring: The mYPAS produces 4 scores, 1 score for each of the 4 behaviors. Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), adding all the produced values, dividing by 4, and multiplying by 100. Minimum score is 22.75, maximum is 100 (< 30 is anxious, > or equal 30 is not anxious). | Only measures Preschool children population ages 2 - 5 years old | Mean | Standard Deviation | units on a scale |
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Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported. |
| OG001 | Total Intravenous Dexmedetomidine | Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported. |
|
|
|
| Primary | Duration of Anesthesia (Minutes) | Measures the time of anesthesia (in minutes) starting from induction of anesthesia to the termination of anesthetic agent | Posted | Mean | Standard Deviation | minutes | From time of anesthesia induction up to the termination of anesthetic agent, assessed up to two hours. |
|
|
|
|
| Primary | Duration of Surgery (Minutes) | Measures the time of surgery after the application of sterile draping up to the end of surgery. | Posted | Mean | Standard Deviation | minutes | From time of surgery up to the termination of anesthetic agent, assessed up to two hours. |
|
|
|
|
| Secondary | Time to Extubation (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. | Posted | Mean | Standard Deviation | minutes | Maximum time to extubate was up to 26 minutes. |
|
|
|
|
| Secondary | Time to Full Recovery | 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. | Posted | Mean | Standard Deviation | minutes | Maximum time observed was up to 105 minutes. |
|
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Intravenous Dexmedetomidine | Adverse events such as hypotension, bradycardia, cardiac arrest or admission to intensive care unit. | 0 | 59 | 0 | 59 | 0 | 59 |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D008738 |
| Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|