Skip to content

The effect of anesthetic management using bispectral index monitorization on postoperative agitation in pediatric anesthesia

The effect of anesthetic management using bispectral index monitorization on postoperative agitation in pediatric anesthesia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000855426
Enrollment
100
Registered
2016-06-29
Start date
2016-04-15
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

One hundred patients (aging 2-7 years) to undergo elective surgery under general anesthesia will be included in the study. The patients will be randomly allocated into two groups. Both patients will be anesthetised using standard methods. In Group 1, deepness of the anesthesia will be measured regarding the heart rate and arterial blood pressure. Doses for inhalation anesthetics will be adjusted according to the vital findings of the patients. In Group 2, deepness of anesthesia will be determined using Bispectral Index monitorization (BIM). Doses for inhalation anesthetics will be determined according to the findings obtained in BIM. Postoperative agitation levels of the patients will be assessed using the Face, Legs, Activity, Cry and Consolability (FLACC) scale and the Postoperative Agitation Scale.

Interventions

The standard anesthesia protocol will consist of oral premedication with midazolam (0.5 mg/kg) followed by an inhaled induction with sevofurane 8% and placement of a peripheral IV cannula. Fentanyl 1 to 1.5 microgram/kg and rocuronium 0.5 to 0.6 mg/kg will be given before intubation. After intubation, the patients will be allocated into two groups randomly. Maintenance of anesthesia will be accomplished by titrating sevofurane (between 0.5% to 3.0%) in a background of 50% air in O2. The patient

The standard anesthesia protocol will consist of oral premedication with midazolam (0.5 mg/kg) followed by an inhaled induction with sevofurane 8% and placement of a peripheral IV cannula. Fentanyl 1 to 1.5 microgram/kg and rocuronium 0.5 to 0.6 mg/kg will be given before intubation. After intubation, the patients will be allocated into two groups randomly. Maintenance of anesthesia will be accomplished by titrating sevofurane (between 0.5% to 3.0%) in a background of 50% air in O2. The patients in Group 1 will receive routine anesthasia while the ones in Group 2 will receive anesthesia in an adjusted manner, with the BIS values between 45-55. Patients in Group 2 will be monitored with use of bispectral index and the level of anesthesia will be adjusted according to the results of the measurements. BIS monitorization will be carried out by the same anesthetist with minimum 5 years’ experience in pediatric anaesthesia, Bispectral Index Scale monitoring is used to prevent intraoperative awakening or awareness and to provide an accurate titration of the anesthesia agents to promote faster recovery from anesthesia. BIS monitoring involves for participants, small monitoring device placed across participant's forehead throughout procedure. Many clinical studies have shown that the administration of anesthetic agents under the guidance of BIS monitoring has allowed for more effective drug use, faster recovery from anesthesia, shorter time to extubation, and better recovery.. The BIS is displayed number between 0 and 100, with 45–55 being suitable for surgical anesthesia. Treating anaesthetist decides based on their clinical discretion how and by how much anaesthesia will be titrated if the BIS value drops out of the range of 45-55 Only patints in group 2 will be assessed with BIS.

Sponsors

Serdar Kokulu
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years
Healthy volunteers
No

Inclusion criteria

The patients who will undergo elective surgery under general anesthesia

Exclusion criteria

Patients who undergo adenoidectomy and toncillectomy Patients with mental retardation or neurologic disorders

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026