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Brain activity during sedation under tow anesthesia regimes

BIS (Bispectral Index Score) after sedation with Midazolam and Propofol combined with Remifentanil vs. Ketamine in pediatric dentistry:A randomized clinical trial study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015042512848N2
Enrollment
32
Registered
2015-09-09
Start date
2015-03-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Mental and behavioural disorders. Other childhood emotional disorder

Interventions

Intervention 1: 0.1µg/kg remifentanile. Intervention 2: 0.5 mg/kg ketamine.
Diagnosis
0.5 mg/kg ketamine
0.1µg/kg remifentanile

Sponsors

Vice Chancellor for Research, Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria:Healthy Systemic Condition; Uncooperative children dentistry operation candidate for sedation; children between 3-7 years old; Exclusion Criteria: The time of sedation more than 45 minutes; accidental problem during the work.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Consciousness and brain activity which can be read through the BIS device connected to the patient. Timepoint: Every five minute as sedation begins, by a By technician unaware of the topic of the study. Method of measurement: By recording from the BIS device.

Secondary

MeasureTime frame
Success in sedation. Timepoint: Every ten minute in recovery room by an unaware(topic of strudy and used regime) technician. Method of measurement: DSTG(Dental Sedation Teachers Group)index.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Dana Tahririan

Isfahan Dental College, Isfahan University of Medical Sciences

tahririan@dnt.mui.ac.ir+98 913 109 7401

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026