Emergence Agitation

N/AActive Not RecruitingNCT07253428

Ain Shams University486 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

486

Conditions

Emergence Agitation Nasal Surgery

Interventions

Neostigmine + AtropineDRUG

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

SugamadexDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Rabah Alharbi

Ha'il, Saudi Arabia

Outcomes

Primary Outcomes

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).

Time frame: perioperative

Secondary Outcomes

duration to full consciousness

Minutes

Time frame: Perioperative

Data from ClinicalTrials.gov

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