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Published on: June 11, 2017
Effects of Dexmedetomidine-Remifentanil on Neurodevelopment of Children after Inhalation Anesthesia: A Randomized
Sang-Hwan Ji1, Pyoyoon Kang2, Sung-Ae Cho3
1Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Insights
Adding dexmedetomidine and remifentanil to sevoflurane anesthesia did not impact neurodevelopmental outcomes in young children at 28-30 months. This study found no significant differences in cognitive or behavioral assessments between the groups.
Area of Science:
- Pediatric Anesthesiology
- Neurodevelopmental Toxicology
- Clinical Trial Research
Background:
- Concerns exist regarding the neurodevelopmental safety of volatile anesthetics in young children.
- Preclinical studies suggest potential neurotoxicity associated with anesthetic agents.
Purpose of the Study:
- To evaluate if combining dexmedetomidine and remifentanil with sevoflurane affects neurodevelopmental outcomes in young children.
- To compare neurodevelopmental status in children receiving sevoflurane alone versus sevoflurane with dexmedetomidine and remifentanil.
Main Methods:
- Prospective, double-blind, randomized clinical trial involving children under 2 years undergoing surgery.
- Participants received either sevoflurane alone (control) or sevoflurane with dexmedetomidine and remifentanil (DEX-R).
- Neurodevelopmental status assessed at 28-30 months using the Korean Leiter International Performance Scale and Child Behavior Checklist.
Main Results:
- No significant difference in anesthesia duration between the control and DEX-R groups.
- Mean end-tidal sevoflurane concentration was significantly lower in the DEX-R group (P < 0.001).
- No significant difference in mean full-scale IQ scores (102.5 DEX-R vs. 103.6 control) or Child Behavior Checklist scores between groups.
Conclusions:
- The combination of dexmedetomidine and remifentanil with sevoflurane anesthesia did not lead to significant differences in neurodevelopmental outcomes at 28-30 months.
- Results suggest that this anesthetic combination is safe regarding neurodevelopmental outcomes in the assessed age group.
- Further long-term follow-up is planned to report the primary endpoint of full-scale IQ at 5 years of age.
Background:
Anesthetic exposure in young children raises concerns about neurodevelopmental safety, with preclinical evidence suggesting potential neurotoxicity of volatile anesthetics. This study aimed to assess whether the combination of dexmedetomidine and remifentanil, by reducing sevoflurane exposure, has any differential effect on neurodevelopmental outcomes in young children compared with sevoflurane alone.
Methods:
This study was a prospective, double-blind, randomized clinical trial including children younger than 2 yr undergoing nonstaged, nonrepetitive surgeries. Participants received dexmedetomidine and remifentanil as adjuncts to sevoflurane (DEX-R group) or sevoflurane alone (control group). The study assessed their neurodevelopmental status at 28 to 30 months using the Korean Leiter International Performance Scale and the Child Behavior Checklist, as predefined secondary outcomes. The primary endpoint-full-scale IQ at 5 yr of age-will be reported after completion of long-term follow-up.
Results:
Among 400 enrolled participants, 343 completed assessments (169 control, 176 DEX-R). There was no difference in the mean anesthesia duration between the control and DEX-R groups (77.1 min vs. 72.8 min; mean difference [95% CI], 4.4 [-3.8 to 12.6]; P = 0.293). The mean end-tidal sevoflurane concentration was significantly lower in the DEX-R group than in the control group (1.8 vol% vs. 2.6 vol%; mean difference [95% CI], -0.9 [-1.0 to -0.7] vol%; P < 0.001). The mean full-scale IQ score was 102.5 ± 11.5 in the DEX-R group and 103.6 ± 11.5 in the control group (mean difference, -1.1; 95% CI, -3.9 to 1.7; P = 0.442). No significant difference was observed in the Child Behavior Checklist total score between groups.
Conclusions:
The addition of dexmedetomidine and remifentanil to sevoflurane anesthesia was not associated with significant differences in neurodevelopmental outcomes at 28 to 30 months compared to sevoflurane alone.
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