Emergence Agitation in Pediatrics After Dexmedetomidine vs. Sevoflurane Anesthesia: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Sevoflurane
- Conditions
- Emergence Delirium
- Sponsor
- Pelita Harapan University
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Emergence Agitation
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Corry Quando Yahya
Pediatric Anesthesiologist and Lecturer at Pelita Harapan University, Department of Anesthesia and Intensive Care
Pelita Harapan University
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Sevoflurane
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.
Intervention: Dexmedetomidine
Outcomes
Primary Outcomes
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.
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
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
- 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.)