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Outcome Measures

Primary Outcomes (1)

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.
Within 48 hours after surgery

Secondary Outcomes (2)

Mean Intraoperative Remifentanil Infusion Rate
During surgery, from induction to discontinuation of anesthesia
Incidence of Supplemental Rocuronium Administration
During surgery, from induction to discontinuation of anesthesia

Study Arms (2)

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.

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.

Device: Multimodal Anesthesia Monitoring (BIS, SPI, TOF)Other: Standard Anesthesia Monitoring

Interventions

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.

Multimodal Monitoring GroupStandard Monitoring Group

Standard Anesthesia MonitoringOther

MeSH Terms

Conditions

Tetralogy of FallotPostoperative Complications

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type

interventional

Phase

not applicable

Allocation

NON RANDOMIZED

Masking

NONE

Purpose

PREVENTION

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

Principal Investigator, Otolaryngologist

Multimodal Monitoring During General Anesthesia in ENT Surgery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Multimodal Monitoring Group

Standard Monitoring Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Multimodal Monitoring Group

Standard Monitoring Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations