Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery

NCT02240368 | Completed Results DMC

• 1 other identifier: A01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery setting. Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established in adult general anesthesia. Their utility is yet undefined in the pediatric population as age seems to affect their ability to track the cerebral hypnotic state in children.

Conditions

Anesthesia; Child

Keywords

Depth anesthesia monitors; Children anesthesia; Bispectral monitor; Entropy monitor

Outcome Measures

Primary Outcomes (2)

• BISPECTRAL Index

  The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group. Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.

  BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours

• Entropy

  The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group. Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.

  Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours

Secondary Outcomes (2)

• BISPECTRAL Index Awaking

  reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia

• Entropy Awaking

  reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia

Study Arms (3)

Group 1

Children age between 1 month to 12 months

Group 2

Children age between 13 months and 36 months

Group 3

Children age between 37 months to 144 months

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patients with age ≤ 12 years old scheduled to undergo general anesthesia and mechanical ventilation for elective surgery

You may qualify if:

• physical status classification (ASA) I - II
• general balanced anesthesia
• mechanically ventilated with laryngeal mask

You may not qualify if:

• severe developmental delay
• neurological disorders or receiving treatment with antiepileptic or stimulant
• patients with preexisting lung or cardiac disease
• airway abnormalities
• marked skin sensitivity and conditions where the placement of the BIS and Entropy sensor or process of assessment would interfere with the surgery procedure.
• patients receiving local anaesthesia, regional block combined with general anaesthesia
• sedation administered by non anesthesiologists for invasive and noninvasive diagnostic or therapeutic procedures

Sponsors & Collaborators

• University of Foggia: lead
• University College, London: collaborator

Study Sites (1)

Ospedali Riuniti

Foggia, FG, 70100, Italy

Location

Related Links

• Speciality school of anesthesia of University of Foggia
• University of Foggia

Results Point of Contact

• Title: Alberto Sciusco
• Organization: University of Foggia

alberto.sciusco@gmail.com

Study Officials

• Michele Dambrosio, Medic

  University of Foggia

  STUDY CHAIR

• Gilda Cinnella, Medic

  University of Foggia

  STUDY DIRECTOR

• Alberto Sciusco, medic

  University of Foggia

  PRINCIPAL INVESTIGATOR

• Pasquale Raimondo, Medic

  University of Foggia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: August 31, 2014
• First Posted: September 15, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 14, 2018
• Results First Posted: July 9, 2015

Record last verified: 2018-07

Locations

IT (1)