Emergence Agitation

NCT07253428 — Not applicable, Active not recruiting, 486 participants, Ain Shams University

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

Registry	NCT07253428, acronym Sugamadex
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	486 (Estimated)
Sponsor	Ain Shams University (Other)
Conditions	Emergence Agitation, Nasal Surgery
Interventions	Neostigmine + Atropine, Sugamadex (Drug)
Dates	start 2025-10-30, primary completion 2025-12-31 (estimated), completion 2026-01-31 (estimated), first posted 2025-11-28, last updated 2025-11-28
Locations	1 site in Saudi Arabia

-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.

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+Detailed description

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).

+Arms and interventions

Arm	Type	Interventions	Description
Sugamadex group	Active comparator	Drug: Sugamadex	Sugamadex group will receive sugamadex as a reversal agent of the muscle relaxant; rocuronium
Neostigmine group	Other	Drug: Neostigmine + Atropine	Neostigmine group will receive the neostigmine as a reversal of the muscle relaxant; rocuronium

Neostigmine + Atropine (Drug), also known as N.group: Neostigmine group will receive the neostigmine as a reversal of the muscle relaxant; rocuronium
Sugamadex (Drug), also known as S.group: 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.

+Outcome measures

Primary outcomes

the incidence of emergence agitation following adult nasal surgeries in patients receiving sugammadex versus a traditional neuromuscular blocking agent reversal method. [perioperative]: Agitation and Emergence Score (AES): This scale is ranging from 0 (calm and cooperative) to 4 (combative, aggressive behavior).

Secondary outcomes

duration to full consciousness [Perioperative]: Minutes

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Rabah Alharbi	Ha'il	Saudi Arabia