Emergence AgitationSugamadexNCT07253428
Emergence Agitation
A study testing Neostigmine + Atropine and Sugamadex in people with Emergence Agitation and Nasal Surgery, run by Ain Shams University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Agitation, Nasal Surgery
- What is being tested?
- Neostigmine + Atropine and Sugamadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Oct 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients aging from 18 to 60 years old, undergoing nasal surgeries such as septoplasty, FESS or Rhinoplasty
- ASA I and ASA II
Who cannot join
- Patients receiving any medications which may affect recovery state e.g. Antipsychotics.
- Smokers
- Obstructive sleep apnea patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMPACT OF SUGAMADEX ON AGITATION UPON EMERGENCE FOLLOWING ADULT NASAL SURGERIES.
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.
Read the 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
- Emergence Agitation, Nasal Surgery
- Being tested
- Neostigmine + Atropine, Sugamadex
- Keywords
- Sugamadex,, Neostigmine, anesthesia recovery, nasal surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine + AtropineDrug
Also called N.group
Neostigmine group will receive the neostigmine as a reversal of the muscle relaxant; rocuronium
SugamadexDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Sugamadex group | Active comparator | Sugamadex group will receive sugamadex as a reversal agent of the muscle relaxant; rocuronium Receives: Drug: Sugamadex |
| Neostigmine group | Other | Neostigmine group will receive the neostigmine as a reversal of the muscle relaxant; rocuronium Receives: Drug: Neostigmine + Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: perioperative
Secondary outcomes (1)
duration to full consciousness
Minutes
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start30 Oct 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabah Nageeb, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253428
- Sponsor's protocol ID
- KASC-KSA
- Other IDs
- SABAHNAGEEB
- Acronym
- Sugamadex
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF SUGAMADEX ON AGITATION UPON EMERGENCE FOLLOWING ADULT NASAL SURGERIES.
- ClinicalTrials.gov ID
- NCT07253428
- Acronym / sponsor ID
- Sugamadex / KASC-KSA
- Conditions
- Emergence Agitation, Nasal Surgery
- Keywords
- Sugamadex,, Neostigmine, anesthesia recovery, nasal surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Sugamadex group | Active comparator | Drug: SugamadexSugamadex group will receive sugamadex as a reversal agent of the muscle relaxant; rocuronium |
| Neostigmine group | Other | Drug: Neostigmine + AtropineNeostigmine group will receive the neostigmine as a reversal of the muscle relaxant; rocuronium |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients aging from 18 to 60 years old, undergoing nasal surgeries such as septoplasty, FESS or Rhinoplasty
- ASA I and ASA II
Key exclusion criteria (3 listed)
- Patients receiving any medications which may affect recovery state e.g. Antipsychotics.
- Smokers
- Obstructive sleep apnea patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neostigmine + AtropineAlso: N.groupNeostigmine group will receive the neostigmine as a reversal of the muscle relaxant; rocuronium | Drug | Neostigmine group |
| SugamadexAlso: S.groupSugamadex 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. | Drug | Sugamadex group |
Primary outcome
the incidence of emergence agitation following adult nasal surgeries in patients receiving sugammadex versus a traditional neuromuscular blocking agent reversal method.
Time frame: perioperative
Agitation and Emergence Score (AES): This scale is ranging from 0 (calm and cooperative) to 4 (combative, aggressive behavior).
1 secondary outcome
duration to full consciousness
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
Related trials for Emergence Agitation
Not yet recruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium
Not yet recruiting
Intranasal Dexmedetomidine Combined With Esketamine for Emergence Quality After Suspension Laryngoscopy
Emergence Agitation, Vocal Cord Polyps
RecruitingObservational study
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
Postoperative Delirium (POD), Gynecologic Cancers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neostigmine + Atropine and Sugamadex in people with Emergence Agitation and Nasal Surgery, run by Ain Shams University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of emergence agitation following adult nasal surgeries in patients receiving sugammadex versus a traditional neuromuscular blocking agent reversal method. (time frame: perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.