Skip to content

Emergence Agitation

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07253428
Acronym
Sugamadex
Enrollment
486
Registered
2025-11-28
Start date
2025-10-30
Completion date
2026-01-31
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation, Nasal Surgery

Keywords

Sugamadex,, Neostigmine, anesthesia recovery, nasal surgery

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.

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).

Interventions

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

DRUGSugamadex

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

no need for masking

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
duration to full consciousnessPerioperativeMinutes

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026