Emergence Agitation (Sugamadex)

Ain Shams University

Status: Active, not recruiting

Conditions: Emergence Agitation; Nasal Surgery

Treatments: Drug: Sugamadex; Drug: Neostigmine + Atropine

Study type: Interventional

Funder types: Other

Identifiers

NCT07253428

KASC-KSA

SABAHNAGEEB (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 486 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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486 participants in 2 patient groups

Sugamadex group

Active Comparator group

Description:

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

Treatment:

Drug: Sugamadex

Neostigmine group

Other group

Description:

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

Treatment:

Drug: Neostigmine + Atropine