Overview
This prospective randomized controlled study will be conducted to evaluate the effects of preoperative lactium on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane anesthesia.
Description
Emergence agitation is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery profile, e.g. sevoflurane. There is a wide variation in the reported incidence, with estimates ranging from 30% to 80%, depending on the definition, assessment tool and time frame of monitoring in the recovery period. Lactium is a synthetic derivative of alpha-s1 casein hydrolysate (ACH) containing the alpha-casozepine peptide, which is one of the main components of milk protein. It contains benzodiazepine-like α-casozepine, which has been shown to interact with gamma-aminobutyric acid receptors to provide anxiolytic and anti-stress effects. In this novel study, we hypothesize that the pre-emptive administration of Lactium may decrease emergence agitation incidence in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence agitation , the efficacy of Lactium in alleviating stress-related symptoms, that may be obtained before anesthetic induction may explain its prophylactic benefit against emergence agitation .
Eligibility
Inclusion Criteria:
- Both gender
- 4 to 7 years age
- American Society of Anesthesiologists (ASA) Physical Status I or II
- Scheduled for adenotonsillectomy surgery under sevoflurane anesthesia
Exclusion Criteria:
- Parents declined to participate in the trial
- Children with behavioral changes; neurological or psychiatric diseases
- Physical or developmental delay
- Sedative or anticonvulsant medication
- Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders
- • History of lactose intolerance