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Active Not RecruitingNCT07253428

Emergence Agitation

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
486 (estimated)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGNeostigmine + AtropineNeostigmine group will receive the neostigmine as a reversal of the muscle relaxant; rocuronium
DRUGSugamadexSugamadex 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.

Timeline

Start date
2025-10-30
Primary completion
2025-12-31
Completion
2026-01-31
First posted
2025-11-28
Last updated
2025-11-28

Locations

1 site across 1 country: Saudi Arabia

Source: ClinicalTrials.gov record NCT07253428. Inclusion in this directory is not an endorsement.