N/A
Completed N=139
Automatic Control of Total Intravenous Anesthesia (ACTIVA)
Anesthesia
Source: ClinicalTrials.gov NCT04432974 ↗
Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Depth of Hypnosis Adequacy — 79.4; 16.2 percentage of maintenance duration
Summary
This study concerns the clinical evaluation of a closed loop control system for the automatic administration of anesthetic drugs in TIVA (Total Intra Venous Anesthesia).
The purpose of the experimentation is to demonstrate that the control system under study is reliable, safe, applicable and capable of inducing and maintaining an optimal anesthetic level.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depth of Hypnosis Adequacy |
79.4; 16.2 | — |
| SECONDARY Number of Participants for Which the System Showed Dysfunctions |
8; 8; 123 | — |
| SECONDARY Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Effect of Drugs Delivery on Heart Rate |
99.7; 0.3 | — |
| SECONDARY Effect of Drugs Delivery on Mean Arterial Pressure (MAP) |
79.0; 15.7 | — |
| SECONDARY Postoperative Heart Rate Stability |
72; 74; 74; 74; 72 | — |
| SECONDARY Postoperative Mean Arterial Pressure (MAP) Stability |
82; 83; 85; 90; 88 | — |
| SECONDARY Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score |
97; 40; 2; 0; 115; 24 | — |
| SECONDARY Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score |
136; 3; 0; 0; 133; 4 | — |
| SECONDARY Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score |
92; 4; 7; 6; 13; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients undergoing total intravenous general anesthesia for elective surgery
Exclusion Criteria
- Patients under the age of 18
- Patients incapable of giving consent
Data sourced from ClinicalTrials.gov (NCT04432974). 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.