Preemptive Oral Lactium to Prevent Emergence Agitation

Tanta University

Status: Completed

Conditions: Adenotonsillectomy; Lactium; Emergence Agitation

Treatments: Other: Placebo control; Drug: Lactium

Study type: Interventional

Funder types: Other

Identifiers

NCT07172594

36264PR1306/7/25

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 135 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 2 patient groups, including a placebo group

Lactium group

Experimental group

Description:

cases will receive preoperative lactium, Lentra sachet (containing 150 mg Lactium) will be totally dissolved in 100 ml water and 50 ml will be given to cases, 2 hours before surgery.

Treatment:

Drug: Lactium

Control group

Placebo Comparator group

Description:

cases will receive 50 ml water added to it powdered vanilla flavor, 2 hours before surgery.

Treatment:

Other: Placebo control