Analgesia Nociception Index Monitoring in Trigeminal Cardiac Reflex During Nasal Septoplasty

ConditionENT Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorFayoum University Hospital

About this trial

This study aims to evaluate the utility of Analgesia Nociception Index (ANI) monitoring as a predictive and preventive tool for TCR during septoplasty. By comparing standard anesthetic monitoring with ANI-guided analgesia, this research seeks to determine whether maintaining optimal autonomic balance can reduce the incidence of trigeminal cardiac reflex (TCR) and improve intraoperative cardiovascular stability.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-60 years.

American society of anesthesiologist physical status I-II

Indicated for primary septoplasty.

Disqualifiers

Known cardiac arrhythmias or conduction disorders.

Use of beta-blockers or antiarrhythmic medications.

Previous nasal surgery and Combined nasal procedures.

Inability to obtain reliable Analgesia Nociception Index readings.

Trial population

Adult patients scheduled for elective nasal septoplasty under general anesthesia will be enrolled.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 2 trial groups
Group A: Group A (Control Group
Group B: Group B (ANI Group)

Trial outcomes

Primary outcomes

1

Primary Outcome - Incidence of trigeminal cardiac reflex

Defined as a decrease in heart rate \>20% from baseline during surgery.

Time frame
3 hours

Secondary outcomes

1

Time interval between Analgesia Nociception Index drop and subsequent heart rate decrease (early warning window).

Time in minutes between occurrence of Analgesia Nociception Index drop and subsequent heart rate decrease

Time frame
3 hours
2

Total intraoperative opioid consumption.

The amount in milligram of opioid consumption.

Time frame
3 hours.
3

Incidence of hypotension or arrhythmias.

Decrease mean arterial pressure less than 60mmgh or occurrence of tachycardia or bradycardia.

Time frame
3 hours

Other outcomes

Sponsors and contacts

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