Emergence Agitation

NCT07253428 | Active Not Recruiting DMC

• 2 other identifiers: KASC-KSASABAHNAGEEB
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 1

Brief Summary

The impact of sugammadex on agitation upon emergence following adult nasal surgeries is an issue which needs to be studied that links anesthetic management with postoperative recovery.

Conditions

Emergence Agitation; Nasal Surgery

Keywords

Sugamadex,; Neostigmine; anesthesia recovery; nasal surgery

Outcome Measures

Primary Outcomes (1)

• the incidence of emergence agitation following adult nasal surgeries in patients receiving sugammadex versus a traditional neuromuscular blocking agent reversal method.

  Agitation and Emergence Score (AES): This scale is ranging from 0 (calm and cooperative) to 4 (combative, aggressive behavior).

  perioperative

Secondary Outcomes (1)

• duration to full consciousness

  Perioperative

Study Arms (2)

Sugamadex group

ACTIVE COMPARATOR

Sugamadex group will receive sugamadex as a reversal agent of the muscle relaxant; rocuronium

Drug: Sugamadex

Neostigmine group

OTHER

Neostigmine group will receive the neostigmine as a reversal of the muscle relaxant; rocuronium

Drug: Neostigmine + Atropine

Interventions

Neostigmine + Atropine DRUG

Neostigmine group will receive the neostigmine as a reversal of the muscle relaxant; rocuronium

Also known as: N.group

Neostigmine group

Sugamadex DRUG

Sugamadex group will receive sugamadex as a reversal agent of the muscle relaxant; rocuronium Neostigmine group will receive the neostigmine as a reversal of the muscle relaxant; rocuronium. Both interventions will be used to compare the effect of adequate muscle relaxation upon the emergence agitation.

Also known as: S.group

Sugamadex group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aging from 18 to 60 years old, undergoing nasal surgeries such as septoplasty, FESS or Rhinoplasty
• ASA I and ASA II

You may not qualify if:

• Patients receiving any medications which may affect recovery state e.g. Antipsychotics.
• Smokers
• Obstructive sleep apnea patients

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Rabah Alharbi

Hail, Saudi Arabia

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Neostigmine; Atropine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no need for masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and intensive care

Model Details: Sugamadex group will receive sugamadex as a reversal agent of the muscle relaxant; rocuronium. the aim is to study the impact of adequate muscle relaxation upon the emergence agitation. This will be compared the neostigmine group which will receive it as a reversal agent of the muscle relaxation

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 28, 2025
• Study Start: October 30, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

SA (1)