Emergence Agitation in Paediatric Day Care Surgery

University of Southern Denmark (SDU)

Status: Completed

Conditions: Postoperative Agitation; Narcotrend; Pain Monitoring; Mdoloris; Heart Rate Variability; Anesthesia Nociception Index; Postoperative Delirium; Anesthesia

Treatments: Device: Narcotrend bispectral index anaesthesia monitor; Device: Mdoloris Anaesthesia Nociception Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06571890

280482

Details and patient eligibility

About

Emergence agitation is a significant and persistent challenge in paediatric anaesthesia, especially in children of preschool age.

In this study, the investigators examined whether anaesthesia titration with either a sleep depth monitor or a pain monitor would result in changed postoperative agitation rates, measured via the Richmond Agitation and Sedation Score (RASS).

93 children participated. The participants were divided into three groups: A conventional anaesthesia group, an EEG (Electroencephalography)- monitored and a pain-monitored group. The pain-monitored children received the most pain medication but were discharged at the same rate as the other children with unchanged rates of nausea and vomiting and less agitation than the sleep-monitored children.

Full description

Healthy preschool outpatients assigned for abdominal/inguinal hernia and cryptorchidism repairs participated after parental consent.

One group received standard anaesthesia induction and maintenance, according to the usual ward regimen. This was done with sevoflurane inhalation, fentanyl bolus and a laryngeal mask airway (Standard group, STD group)

The second group received standard anaesthesia as well only this time the sevoflurane titration was guided via the Nacotrend bispectral index monitor, towards a narcotrend index of 2-4. (Narcotrend group, NCT group)

The third group also received standard anaesthesia and was additionally monitored with a Mdoloris Anaesthesia Nociception Index (ANI) monitor for perioperative nociception. When a nociceptive threshold was exceeded, an extra bolus of fentanyl of 1 mcg/kg was given (ANI group)

All children were then escorted to the postoperative care unit for wakeup. A Richmond Agitation Sedation Scale score (RASS-score) was made every 15 minutes until discharge. This was analysed with Kaplan-Meyer mortality graph, along with usual statistics of secondary outcomes.

The children in the ANI group received the least fentanyl and were discharged no later than all the other children.

Enrollment: 93 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Day surgery for abdominal and urological procedures
• Children 1-6 years
• American Society of Anesthesiologist (ASA) scale 1- 2
• Airway management with laryngeal masks or facemasks
• Consent from both parents/legal representatives
• Rescue propofol is allowed

Exclusion criteria

• Age less than 1 or older than 6 years
• ASA > 2
• Endotracheal intubation;
• Lack of consent from both parents/legal representatives
• Daily intake of medications that interfered with the autonomic nervous system reactivity, for example, inhaled beta-agonists for bronchial asthma and total intravenous anaesthesia (TIVA).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

Standard (STD)

No Intervention group

Description:

Standard anaesthesia with Sevoflurane Inhalation anaesthesia, fentanyl and a laryngeal mask

Narcotrend (NCT)

Experimental group

Description:

Standard anaesthesia with Sevoflurane inhalation anaesthesia, fentanyl and a laryngeal mask. Sevoflurane concentration was titrated via a Narcotrend bispectral anaesthesia monitor.

Treatment:

Device: Narcotrend bispectral index anaesthesia monitor

Anaesthesia Nociception Index Monitor (ANI)

Experimental group

Description:

Standard anaesthesia with Sevoflurane inhalation anaesthesia, fentanyl and a laryngeal mask. Fentanyl dosage titrated with guidance from Mdoloris ANI monitor, a heart rate variability-based nociception monitor. When a threshold value is exceeded, additional fentanyl 1 mcg/kg is given

Treatment:

Device: Mdoloris Anaesthesia Nociception Monitor