Emergence Delirium
Conditions
Keywords
Emergence Agitation, Dexmedetomidine, Delirium, Children, Facial Cleft
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.
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.
Interventions
DRUGDexmedetomidine
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.
DRUGSevoflurane
Inhalation Sevoflurane will be administered as an anesthetic maintenance agent. Sevoflurane at 2 - 3 Vol% will be administered throughout the operative procedure.
Sponsors
Pelita Harapan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients are selected randomly using a computer-generated device to become a control arm or a treatment arm
Intervention model description
Pediatrics ages 3 months to 10 years
Eligibility
Sex/Gender
ALL
Age
3 Months to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence Agitation | 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. |
| Duration of Anesthesia (Minutes) | 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 |
| Duration of Surgery (Minutes) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Extubation (Minutes) | 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. |
| Time to Full Recovery | 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. |
Countries
Indonesia
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Inhalation Sevoflurane Subjects receiving Sevoflurane as their maintenance anesthetic | 62 |
| Total Intravenous Dexmedetomidine Subjects receiving Dexmedetomidine as their maintenance anesthetic | 59 |
| Total | 121 |
Baseline characteristics
| Characteristic | Total Intravenous Dexmedetomidine | Inhalation Sevoflurane | Total |
|---|---|---|---|
| Age, Continuous | 24 months | 24 months | 24 months |
| Modified Yale Preoperative Anxiety Scale (mYPAS) | 54.3 units on a scale STANDARD_DEVIATION 15 | 56.1 units on a scale STANDARD_DEVIATION 13.7 | 55.2 units on a scale STANDARD_DEVIATION 14.2 |
| Preschool Children | 3.2 years STANDARD_DEVIATION 1.1 | 3.4 years STANDARD_DEVIATION 1.1 | 3.3 years STANDARD_DEVIATION 1.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 59 Participants | 62 Participants | 121 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 29 Participants | 32 Participants | 61 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
| Type of operation (Labioplasty/Palatoplasty) Labioplasty | 33 Participants | 30 Participants | 63 Participants |
| Type of operation (Labioplasty/Palatoplasty) Palatoplasty | 26 Participants | 32 Participants | 58 Participants |
| Weight (kg) | 10.6 kilogram STANDARD_DEVIATION 5 | 11.4 kilogram STANDARD_DEVIATION 5.4 | 10.9 kilogram STANDARD_DEVIATION 5.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 59 |
| other Total, other adverse events | 0 / 62 | 0 / 59 |
| serious Total, serious adverse events | 0 / 62 | 0 / 59 |
Outcome results
Primary
Duration of Anesthesia (Minutes)
Measures the time of anesthesia (in minutes) starting from induction of anesthesia to the termination of anesthetic agent
Time frame: From time of anesthesia induction up to the termination of anesthetic agent, assessed up to two hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhalation Sevoflurane | Duration of Anesthesia (Minutes) | 50 minutes | Standard Deviation 17 |
| Total Intravenous Dexmedetomidine | Duration of Anesthesia (Minutes) | 46 minutes | Standard Deviation 15 |
p-value: 0.345Wilcoxon (Mann-Whitney)
Primary
Duration of Surgery (Minutes)
Measures the time of surgery after the application of sterile draping up to the end of surgery.
Time frame: From time of surgery up to the termination of anesthetic agent, assessed up to two hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhalation Sevoflurane | Duration of Surgery (Minutes) | 41 minutes | Standard Deviation 15 |
| Total Intravenous Dexmedetomidine | Duration of Surgery (Minutes) | 39 minutes | Standard Deviation 14 |
p-value: 0.45Wilcoxon (Mann-Whitney)
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.
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.
Population: Scale of 1.0 - 2.9 indicates no emergence agitation, a scale of 3.0 - 5.0 indicates emergence agitation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhalation Sevoflurane | Emergence Agitation | 3.9 Score on a scale | Standard Deviation 0.9 |
| Total Intravenous Dexmedetomidine | Emergence Agitation | 2.5 Score on a scale | Standard Deviation 0.6 |
p-value: 0.00195% CI: [14.098, 118.972]Chi-squared, Corrected
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.
Time frame: Maximum time to extubate was up to 26 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhalation Sevoflurane | Time to Extubation (Minutes) | 9.5 minutes | Standard Deviation 3.7 |
| Total Intravenous Dexmedetomidine | Time to Extubation (Minutes) | 10.4 minutes | Standard Deviation 4.6 |
p-value: 0.356Wilcoxon (Mann-Whitney)
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.
Time frame: Maximum time observed was up to 105 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhalation Sevoflurane | Time to Full Recovery | 51.7 minutes | Standard Deviation 16.3 |
| Total Intravenous Dexmedetomidine | Time to Full Recovery | 59.9 minutes | Standard Deviation 16.4 |
p-value: 0.0795% CI: [2.31, 14.095]t-test, 2 sided