Preoperative Nebulized Dexmedetomidine Versus Nebulized Magnesium Sulphate in Reducing Emergence Agitation in FESS

NCT07677917 | Enrolling By Invitation Phase 1

• 1 other identifier: FMASU MD 05/2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Emergence agitation after sinus surgery is a common postoperative complication characterized by confusion, disorientation, and potentially violent behavior as a patient wakes from general anesthesia.This study compare the effect of nebulized dexmedetomidine versus nebulized magnesium sulphate in reducing emergence agitation in adult undergoing functional endoscopic sinus surgery. This study aims to compare preoperative nebulized dexmedetomidine and nebulized magnesium sulphate in reducing emergence agitation in adult undergoing functional endoscopic sinus surgery.

Conditions

Screening

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will Visual Analogue Scale (VAS)score after anesthesia

  Pain will be assessed by VAS Score where 0 is no pain and 10 is the worst pain possible

  30 minutes after operation in PACU

Secondary Outcomes (3)

• The recovery time

  30 minutes after operation in PACU

• Aono's four-point score will assessed as secondary endpoints.

  30 minutes after operation in PACU

• The number, severity, and duration of agitation episode.

  30 minutes after operation in PACU

Study Arms (2)

Group D (Dexmedetomedine)

EXPERIMENTAL

Patients in Group D will be nebulized with 1 μg/kg nebulized dexmedetomidine completed to 3 ml using normal saline 30 min before operation

Drug: Dexmedetomidine

Group M ( Magnesium Sulphate)

EXPERIMENTAL

Group M will be nebulized with 250 mg nebulized magnesium sulfate completed to 3 ml using normal saline

Drug: Magnesium sulfate

Interventions

Dexmedetomidine DRUG

Patients in Group D will be nebulized with 1 μg/kg nebulized dexmedetomidine completed to 3 ml using normal saline 30 min before operation.The solution for nebulization will be administered by an anesthesiologist.

Also known as: Precedex

Group D (Dexmedetomedine)

Magnesium sulfate DRUG

Patients in Group M will be nebulized with 250 mg nebulized magnesium sulphate completed to 3 ml using normal saline 30 min before operation . The solution for nebulization will be administered by an anesthesiologist.

Also known as: magnesium sulphate

Group M ( Magnesium Sulphate)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients between 21 and 50 years of age undergoing elective functional endoscopic sinus surgery.
• American Society of Anesthesiologists physical status classification (ASA) I and II.

You may not qualify if:

• Patient's refusal.
• Complicated sinus surgery.
• History of allergy to any of the study drugs.
• Baseline HR≤60 beat/min.
• Baseline mean arterial pressure (MAP)≤70 mmHg.
• Psychiatric illness.
• Cerebrovascular insufficiency.
• Pregnancy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Haidy A Fekry, MBBCH,MSc

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: July 1, 2026
• Study Start: January 22, 2026
• Primary Completion: July 22, 2026
• Study Completion (Estimated): January 22, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 6-12 months and for up to 5 years
• Access Criteria: Access will be granted to researchers who submit a methodologically sound proposal to the principal investigator . Requestes should be directed to haidy.atef@med.asu.edu.eg.

Locations

EG (1)