General AnesthesiaNCT07895836
Multimodal Monitoring During General Anesthesia in ENT Surgery
A study testing Multimodal Anesthesia Monitoring (BIS, SPI, TOF) and Standard Anesthesia Monitoring in people with General Anesthesia, run by Barbara Verro at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Multimodal Anesthesia Monitoring (BIS, SPI, TOF) and Standard Anesthesia Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 28 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Patients undergoing ear, nose, and throat (ENT) surgery under general anesthesia.
- Ability to understand the study information and provide informed consent.
Who cannot join
- Contraindications to general anesthesia.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Palermo, 90127
About this study
Official title: Continuous Multiparametric Monitoring During General Anesthesia in ENT Surgery
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.
Read more
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.
Read the detailed description
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.
- Conditions
- General Anesthesia
- Being tested
- Multimodal Anesthesia Monitoring (BIS, SPI, TOF), Standard Anesthesia Monitoring
- Keywords
- Multimodal Anesthesia Monitoring, Bispectral Index (BIS), Surgical Pleth Index (SPI), Train-of-Four (TOF) Monitoring, General Anesthesia, Neuromuscular Blockade Monitoring, Otorhinolaryngologic Surgery, Postoperative Complications
- Medical subject headings
- Tetralogy of Fallot, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Anesthesia Monitoring (BIS, SPI, TOF)Device
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 Anesthesia MonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Monitoring Group | Experimental | 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. Receives: Device: Multimodal Anesthesia Monitoring (BIS, SPI, TOF) |
| Standard Monitoring Group | Active comparator | 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. Receives: Device: Multimodal Anesthesia Monitoring (BIS, SPI, TOF); Other: Standard Anesthesia Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 48 hours after surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: During surgery, from induction to discontinuation of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start28 Feb 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to two parallel groups using a predetermined alternating sequence (1:1 allocation). The intervention group received standard intraoperative monitoring supplemented by BIS, SPI, and quantitative TOF monitoring, while the control group received standard intraoperative monitoring alone. Each participant received only the monitoring strategy assigned to their group. Allocation was non-randomized, with no allocation concealment.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Verro
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Responsible party
- Sponsor-investigator, Barbara Verro, University of Palermo
- Investigators
- Barbara Verro, MD PhD, Principal investigator, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895836
- Sponsor's protocol ID
- CCF 000124
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Multiparametric Monitoring During General Anesthesia in ENT Surgery
- ClinicalTrials.gov ID
- NCT07895836
- Acronym / sponsor ID
- CCF 000124
- Conditions
- General Anesthesia
- Keywords
- Multimodal Anesthesia Monitoring, Bispectral Index (BIS), Surgical Pleth Index (SPI), Train-of-Four (TOF) Monitoring, General Anesthesia, Neuromuscular Blockade Monitoring, Otorhinolaryngologic Surgery, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Barbara VerroUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to two parallel groups using a predetermined alternating sequence (1:1 allocation). The intervention group received standard intraoperative monitoring supplemented by BIS, SPI, and quantitative TOF monitoring, while the control group received standard intraoperative monitoring alone. Each participant received only the monitoring strategy assigned to their group. Allocation was non-randomized, with no allocation concealment.
| Arm | Type | Receives |
|---|---|---|
| Multimodal Monitoring Group | Experimental | Device: Multimodal Anesthesia Monitoring (BIS, SPI, TOF)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. |
| Standard Monitoring Group | Active comparator | Device: Multimodal Anesthesia Monitoring (BIS, SPI, TOF), Other: Standard Anesthesia MonitoringParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older.
- Patients undergoing ear, nose, and throat (ENT) surgery under general anesthesia.
- Ability to understand the study information and provide informed consent.
Key exclusion criteria (1 listed)
- Contraindications to general anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Anesthesia Monitoring (BIS, SPI, TOF)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. | Device | Multimodal Monitoring Group, Standard Monitoring Group |
| Standard Anesthesia MonitoringStandard 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. | Other | Standard Monitoring Group |
Primary outcome
Incidence of Postoperative Anesthesia-Related Complications
Time frame: Within 48 hours after surgery
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.
2 secondary outcomes
Mean Intraoperative Remifentanil Infusion Rate
Time frame: During surgery, from induction to discontinuation of anesthesia
Incidence of Supplemental Rocuronium Administration
Time frame: During surgery, from induction to discontinuation of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Verro, MD PhD principal investigator
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Anesthesia Monitoring (BIS, SPI, TOF) and Standard Anesthesia Monitoring in people with General Anesthesia, run by Barbara Verro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Anesthesia-Related Complications (time frame: Within 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.