NCT06866145

Brief Summary

Dexmedetomidine Infusion in either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2024

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

May 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 8, 2025

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

March 4, 2025

Last Update Submit

September 2, 2025

Conditions

Rhinosinusitis

Keywords

endoscopic sinus surgery , dexmedetomidine, surgical field visibility

Outcome Measures

Primary Outcomes (1)

  • Surgical field visibility

    Surgical field visibility assessed every 15 minutes based on Boezaart scale from 0 to 5 as 0 is the worst score and 5 is the best

    intraoperative

Study Arms (2)

TIVA group

OTHER

patients receives total intravenous anesthesia

Procedure: functional endoscopic sinus surgeryDrug: Dexmedetomidine

inhalational group

OTHER

patients receives inhalational anesthesia

Procedure: functional endoscopic sinus surgeryDrug: Dexmedetomidine

Interventions

functional endoscopic sinus surgeryPROCEDURE

sinus surgery

TIVA groupinhalational group
DexmedetomidineDRUG

precedex

TIVA groupinhalational group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) class I and II patients undergoing endoscopic sinus surgery in the age group from 18-50 years.

You may not qualify if:

  • History of allergy to medications used in the study, refusal of patients to participate, hepatic or renal dysfunction, chronic pain condition, psychological and neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Menoufia university hospital

Menoufia, Shibin Elkom, 6121890, Egypt

Location

Menoufia university hospital

Shibin Elkom, Egypt

Location

MeSH Terms

Conditions

Rhinosinusitis

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
surgeon
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

May 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

September 8, 2025

Record last verified: 2024-03

Locations

EG(2)