BIS Monitoring of the Depth of Anaesthesia in Children

NCT02664142 | Completed

• 1 other identifier: FNO-KARIM-3
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

General anaesthesia (GA) is, according to many definitions, the greatest gift presented to the medical art (S. B. Nuland). One of the aims of GA is to achieve the optimal depth of anaesthesia and rapid emergence from general anaesthesia. In order to achieve this goal, it is necessary to observe the clinical condition of the patient, and at the same time monitor the patient's overall condition. With the currently available options of GA management (e.g. use of intravenous anaesthetics, strong analgesics and modern volatile anaesthetics, in combination with various methods of topical anaesthesia) the importance of methods measuring the depth of GA increases. The depth of GA may be defined as a continuous progressive decreasing of the central nervous system, together with a decreased reactivity to stimuli. In the course of GA, perioperative awareness is detected in 0.1-0.2% of cases. Awakening during a surgical procedure may result in significant psychological complications (e.g. post-traumatic stress disorder), and the patient may suffer from a serious long-time disorder.

Conditions

General Surgery; Anaesthesia

Keywords

General Surgery; Child; Anaesthesia; Depth of anaesthesia; BIS monitoring

Outcome Measures

Primary Outcomes (1)

• Occurrence of perioperative complications

  The occurrence of perioperative complications due to inappropriate depth of general anaesthesia will be observed.

  24 months

Secondary Outcomes (3)

• Shortening of the emergence from general anaesthesia

  24 months

• Decrease in the amount of inhalation anaesthetic used

  24 months

• Decrease in the amount of analgesics used

  24 months

Other Outcomes (1)

• Decrease of complications at recovery room

  24 months

Study Arms (2)

BIS Group

EXPERIMENTAL

BIS monitor will be used during the GA monitoring, the BIS value will be known to the anaesthetist (investigator) * GA induction (Phase 1): 1. inhalation introduction (Sevorane, 02,AIR (flow 2:2 l/min)) or 2. intra-venous introduction: (Suphentanil: (0.1-0.3 ug/kg iv.), Propofol (2-2,5 mg/kg iv.), or Mivacron (0.15-2mg/kg ),Tracrium (0.3-0.6mg/kg) * anaesthesia (Phase 2, Phase 3): 1. hypnotic component: titration of Sevorane concentration, with the aim of achieving the BIS values of 40-60%, bearing gas mixture: O2/AIR (in proportion of 1:1, with 0.5:0.5 flows) 2. analgesic component: Suphentanil (continuous dose of 0.1-0.3ug/kg iv. every 20-30 min) 3. relaxation: Mivacron (continuous dose of 0.1mg/kg iv.), Tracrium(0.3-0.6 mg/kg) Patients in this group will be administered anaesthetic, in order to achieve and maintain the required general anaesthesia.

Procedure: BIS Group; Drug: Anaesthetics

Non-BIS Group

EXPERIMENTAL

BIS monitor will be used during the GA monitoring, however the BIS value will not be known to the anaesthetist (investigator) * GA induction (Phase 1): 1. inhalation introduction (Sevorane, 02,AIR (flow 2:2 l/min)) or 2. intra-venous introduction: (Suphentanil: (0.1-0.3 ug/kg iv.), Propofol (2-2,5 mg/kg iv.), or Mivacron (0.15-2mg/kg ),Tracrium (0.3-0.6mg/kg) * anaesthesia (Phase 2, Phase 3): 1. hypnotic component: titration of Sevorane concentration, with the aim of achieving the MAC value appropriate for the age of the child, bearing gas mixture: O2/AIR (in proportion of 1:1, with 0.5:0.5 flows) 2. analgesic component: Suphentanil (continuous dose of 0.1-0.3ug/kg iv. every 20-30 min) 3. relaxation: Mivacron (continuous dose of 0.1mg/kg iv.), Tracrium(0.3-0.6 mg/kg) Patients in this group will be administered anaesthetic, in order to achieve and maintain the required general anaesthesia.

Procedure: Non-BIS Group; Drug: Anaesthetics

Interventions

BIS Group PROCEDURE

BIS monitoring will be used in the BIS Group patients. The BIS value will be known to the anaesthetist, who will be able to act accordingly.

BIS Group

Non-BIS Group PROCEDURE

BIS monitoring will be used in the Non-BIS Group patients. The BIS value will NOT be known to the anaesthetist and will be observed by a trained co-investigator, with subsequent evaluation.

Non-BIS Group

Anaesthetics DRUG

Anaesthetics will be administered in both experimental groups, in order to maintain the required general anaesthesia.

BIS Group; Non-BIS Group

Eligibility Criteria

• Age: 15 Days - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• appropriate age
• informed consent form signed by both parents (according to national legislation)
• need to undergo a procedure in general anaesthesia
• ASA I classification

You may not qualify if:

• non-signing of the informed consent form by both parents
• ASA classification higher than I

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Jan Divak, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 26, 2016
• Study Start: June 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)