NCT07435870

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Apr 2026May 2027

First Submitted

Initial submission to the registry

February 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

February 21, 2026

Last Update Submit

March 2, 2026

Conditions

ENT Disease

Keywords

Analgesia Nociception IndexTrigeminal Cardiac ReflexSeptoplasty

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome - Incidence of trigeminal cardiac reflex

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

    3 hours

Secondary Outcomes (3)

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

    3 hours

  • Total intraoperative opioid consumption.

    3 hours.

  • Incidence of hypotension or arrhythmias.

    3 hours

Study Arms (2)

Group A (Control Group

Standard monitoring including heart rate, non-invasive blood pressure, oxygen saturation, and bispectral index (BIS).

Group B (ANI Group)

Standard monitoring plus continuous ANI monitoring, with intraoperative analgesia adjusted to maintain Analgesia Nociception Index ( ANI) values between 50 and 70

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 18-60 years.
  • American society of anesthesiologist physical status I-II
  • Indicated for primary septoplasty.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum univeristy hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

Related Publications (3)

  • Lapi D, Scuri R, Colantuoni A. Trigeminal Cardiac Reflex and Cerebral Blood Flow Regulation. Front Neurosci. 2016 Oct 20;10:470. doi: 10.3389/fnins.2016.00470. eCollection 2016.

    PMID: 27812317RESULT

  • Lunardi G, Giombi F, Pace GM, Cerasuolo M, Spriano G, Malvezzi L. Measuring Nasal Airway Resistance to Personalize Surgery for Nasal Obstruction in OSA Patients. J Pers Med. 2025 Dec 8;15(12):608. doi: 10.3390/jpm15120608.

    PMID: 41440971RESULT

  • Dadgarnia MH, Baradaranfar MH, Mazidi M, Azimi Meibodi SM. Assessment of Septoplasty Effectiveness using Acoustic Rhinometry and Rhinomanometry. Iran J Otorhinolaryngol. 2013 Spring;25(71):71-8.

    PMID: 24303423RESULT

MeSH Terms

Conditions

Otorhinolaryngologic Diseases

Study Officials

  • Mohamed Ahmed Hamed, Professor

    Fayoum University Hospital

    PRINCIPAL INVESTIGATOR

  • Fatmaelzahraa Omar Bahr, Lecture

    Fayoum University Hospital

    STUDY DIRECTOR

  • Mohamed Eid Khalil, Lecture

    Fayoum University Hospital

    STUDY CHAIR

Central Study Contacts

Fatmaelzahraa Omar Bahr, lecture

CONTACT

00201097356769drfatmabahr85@gmil.com

Mohmed Ahmed Hamed, professor

CONTACT

0020101050999736mah07@fayoum.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecture

Study Record Dates

First Submitted

February 21, 2026

First Posted

February 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

EG(1)