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COMPLETED
NCT07895836
NA

Multimodal Monitoring During General Anesthesia in ENT Surgery

Sponsor: Barbara Verro

View on ClinicalTrials.gov

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. 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.

Official title: Continuous Multiparametric Monitoring During General Anesthesia in ENT Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-02-28

Completion Date

2025-12-31

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DEVICE

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.

OTHER

Standard Anesthesia Monitoring

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.

Locations (1)

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Palermo, Italy