N/A
Completed N=40
Closed Loop Propofol Administration in Pediatric Cardiac Surgery
Pediatric Cardiac Surgery · Intraoperative Awareness · Automated Drug Delivery
Source: ClinicalTrials.gov NCT01600287 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Percentage of Time Bispectral Index(BIS) Remains+/-10 of Target — 77.4; 75 percentage of time
Summary
The purpose of the study is to evaluate and compare the feasibility, efficacy and safety of IAADS (Improved Anaesthetic Agent Delivery System) for propofol anaesthesia against manual control using bispectral index in paediatric patients undergoing open heart surgery under cardio-pulmonary bypass.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time Bispectral Index(BIS) Remains+/-10 of Target |
77.4; 75 | — |
| SECONDARY Median Performance Error(MDPE) |
6; -7 | — |
| SECONDARY Median Absolute Performance Error(MDAPE) |
12; 13 | — |
| SECONDARY Wobble |
9; 11 | — |
| SECONDARY Percentage of Time Heart Rate Remains Within 25% of Pre-op Baseline |
83.3; 80.5 | — |
| SECONDARY Percentage of Time Mean Arterial Pressure Remains Within 25% of Pre-op Baseline |
83.8; 72.8 | — |
| SECONDARY Intra-operative Awareness |
0; 0 | — |
| SECONDARY Divergence |
0.02; -0.097 | — |
| SECONDARY Global Score |
30.09; 34.12 | — |
| SECONDARY Intraoperative Phenylephrine Used (Pre CPB) |
5.79; 16.92 | — |
Eligibility Criteria
Inclusion Criteria
- Children, aged 5-18 years and ASA (American Society of Anesthesiology) physical status 2-3, planned for elective open heart surgery under general anaesthesia.
Exclusion Criteria
- Patients weighing more than ±30% of ideal body weight.
- Patients having neurological/psychological disorders or on psychoactive medications.
- Patients belonging to NYHA (New York Heart Association) class IV.
- Patients with severe stenotic valvular lesions, eg, mitral or aortic stenosis.
- Patients with known allergy to propofol or any of its constituents.
- Patients having severe pulmonary arterial hypertension.
- Patients with cyanotic congenital heart disease.
- Patients requiring deep hypothermic circulatory arrest during surgery.
Data sourced from ClinicalTrials.gov (NCT01600287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.