An interventional study of Multimodal Anesthesia Monitoring (BIS, SPI, TOF) and Standard Anesthesia Monitoring in General Anesthesia Monitoring, sponsored by Barbara Verro. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Barbara Verro · Not applicable, Interventional, and Prevention
This study evaluated whether using several monitoring methods together during general anesthesia could improve patient safety and help anesthesiologists adjust medication doses in adults undergoing ear, nose, and throat (ENT) surgery.
The study included 200 adult patients at a university hospital in Palermo, Italy. Patients were assigned alternately to one of two groups. One group received standard monitoring together with additional monitoring of anesthesia depth (BIS), responses to surgical stimulation (SPI), and muscle relaxation (TOF). The other group received standard monitoring alone. Group assignment followed a fixed alternating sequence rather than random selection.
The researchers compared the amount of anesthetic medication used during surgery and the occurrence of anesthesia-related complications during the first 48 hours after surgery, including delayed recovery of breathing, nausea and vomiting, shivering, and residual muscle weakness.
The study was conducted between February and December 2025 and has been completed.
Adequate control of anesthetic depth, nociceptive responses, and neuromuscular blockade is important for patient safety during general anesthesia. Conventional intraoperative monitoring provides essential physiological information but may not fully characterize these three components of anesthesia.
The study evaluated an integrated monitoring strategy combining the Bispectral Index (BIS), Surgical Pleth Index (SPI), and quantitative train-of-four (TOF) monitoring during ear, nose, and throat surgery. These technologies provide complementary information to support individualized administration of anesthetic, analgesic, and neuromuscular blocking agents.
The study was conducted prospectively at a single university hospital. Consecutive eligible patients were assigned to two parallel groups using a predetermined alternating sequence. This allocation method was non-random and predictable, and allocation concealment was not implemented. The study is therefore classified as a prospective controlled non-randomized interventional trial, with alternating allocation sometimes described as quasi-random allocation.
The investigation focused on anesthetic drug requirements and postoperative anesthesia-related complications. The original ethics-approved protocol, dated November 29, 2024, described the monitoring strategy and general safety and drug-optimization objectives but did not formally specify the alternating allocation sequence or designate a primary outcome. The study is being registered retrospectively after completion.
94 studies on the registry are indexed under Tetralogy of Fallot; 26 are open to participants now.
This study's enrollment of 200 is above the median of 52 across 53 interventional studies indexed under Tetralogy of Fallot.
Browse Tetralogy of Fallot studies →This is the only study on the registry with Barbara Verro as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants received standard intraoperative monitoring supplemented by Bispectral Index (BIS), Surgical Pleth Index (SPI), and quantitative train-of-four (TOF) monitoring to guide anesthetic, analgesic, and neuromuscular blocking drug administration during general anesthesia for ENT surgery.
Device: Multimodal Anesthesia Monitoring (BIS, SPI, TOF)
Participants received standard intraoperative monitoring during general anesthesia for ENT surgery, without the additional integrated BIS, SPI, and quantitative TOF-guided monitoring strategy used in the intervention group.
Device: Multimodal Anesthesia Monitoring (BIS, SPI, TOF) · Other: Standard Anesthesia Monitoring
Integrated intraoperative monitoring using the Bispectral Index (BIS) to assess anesthetic depth, the Surgical Pleth Index (SPI) to assess nociceptive responses, and quantitative train-of-four (TOF) monitoring to assess neuromuscular blockade. Monitoring information was used to support individualized adjustment of anesthetic, analgesic, and neuromuscular blocking agents during general anesthesia.
Standard intraoperative anesthesia monitoring according to routine clinical practice during ear, nose, and throat surgery, without the additional integrated BIS, SPI, and quantitative TOF-guided monitoring strategy.
Incidence of Postoperative Anesthesia-Related Complications
Proportion of participants experiencing at least one anesthesia-related postoperative complication, including delayed recovery of spontaneous breathing, postoperative nausea and vomiting (PONV), shivering, postoperative residual neuromuscular blockade (PORC), or constipation. Each participant was counted once if one or more of these complications occurred.
Time frame: Within 48 hours after surgery
Mean Intraoperative Remifentanil Infusion Rate
Mean remifentanil infusion rate administered during general anesthesia, expressed in micrograms per kilogram of body weight per minute (μg/kg/min), compared between the multimodal monitoring and standard monitoring groups.
Time frame: During surgery, from induction to discontinuation of anesthesia
Incidence of Supplemental Rocuronium Administration
Proportion of participants requiring at least one additional bolus of rocuronium after the initial dose during general anesthesia, compared between the two study groups.
Time frame: During surgery, from induction to discontinuation of anesthesia
Plan to share: No — Individual participant data will not be made publicly available due to patient confidentiality and data protection considerations. Aggregate study results may be reported in scientific publications.
No publications or documents are linked to this record.
Ran from Feb 2025 to primary completion in Dec 2025, 10 months.
Of 26 interventional studies with no phase under Tetralogy of Fallot, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.