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OpenTrials
Active, Not Recruiting

NCT Number: NCT07253428

Emergence Agitation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabah Alharbi

Ha'il, Saudi Arabia

About this study

The included patients in the study will not be premedicated by sedatives, they will be preoxygenated for 5 minutes by 100% oxygen. The induction of anesthesia will be by fentanyl 100 microgram, 1.5 mg/kg lidocaine followed by propofol 2mg/kg, and rocuronium 0.5 mg/kg. oral intubation will be commenced and an oral pack will be inserted. Anesthesia will be maintained by sevoflurane 2% and N2O : O2 ratio of 50: 50.

Hypotensive anesthesia will be conducted by labetalol 10- 20 mg i.v. At the end of surgery inhalational anesthesia will be abandoned and muscle relaxant will be antagonized either by sugamadex 1mg/kg or neostigmine 0.05 mg/kg mixed with atropine 0.02 mg/kg. After awakening of the of the patients, emergence agitation will be assessed by Agitation and Emergence Score (AES): This scale is ranging from 0 (calm and cooperative) to 4 (combative, aggressive behavior).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Neostigmine + Atropine

Drug

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

Other names: N.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.

Other names: S.group

Primary outcomes

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

    Time frame: perioperative

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

Secondary outcomes

  1. duration to full consciousness

    Time frame: Perioperative

    Minutes

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

IMPACT OF SUGAMADEX ON AGITATION UPON EMERGENCE FOLLOWING ADULT NASAL SURGERIES.

Acronym: Sugamadex

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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