Postoperative AgitationNCT06686511
The Effect of Preoperative Counseling on Emergence Agitation in Patients Candidate for Nasal Surgeries
An observational study of Postoperative Agitation, run by Cairo University at 1 site in Egypt.
Trial summary
Emergence agitation is a post anesthetic phenomenon that develops in the early phase of general anesthesia recovery,The aim of our study to investigate the effect of preoperative educational counselling of the patient undergoing nasal surgery on emergence agitation . Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Agitation
- How many people
- 256 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2024to 15 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASA I or II patients of both genders undergoing nasal surgery in the age between 21 to 65 years old will be included in the study
Who may be able to join
- Both genders.
- Patients undergoing nasal surgery
- American Society of Anesthesiologist (ASA) I or II physical status.
- Between 18 and 65 years of age.
Who cannot join
- ● Patients with communication difficulties.
- ASA Ⅲ and Ⅳ patients.
- Mentally retarded patients.
- In-ability to postpone anti-coagulation medications.
- Central or peripheral neurological disease.
- Drug or alcohol abuse.
- Localized infection at nose.
- Bleeding disorder (platelets count less than 100,000 or INR more than 1.4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Counseling on Emergence Agitation in Patients Candidate for Nasal Surgeries : a Prospective Randomized Controlled Study
Emergence agitation is a post anesthetic phenomenon that develops in the early phase of general anesthesia recovery,The aim of our study to investigate the effect of preoperative educational counselling of the patient undergoing nasal surgery on emergence agitation .
Read the detailed description
While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children. Especially, our clinical impression is that nasal surgical patients admitted to the postbanesthesia care unit (PACU) have suffered emergence agitation more frequently than other surgical patients, possibly due to a sense of suffocation during emergence from anesthesia.
preoperative counselling and repeated verbal stimulation of orientation may serve as a simple and easily applicable strategy to reduce emergence agitation after general anaesthesia .
There have been studies looking into the effect of pre-operative counselling on individual aspects internationally like anxiety, BMI, serum cholesterol , length of stay , pain .( Six trials were identified and have produced conflicting findings. Some trials have demonstrated the effects of preoperative education on improving physical and psychosocial recovery of cardiac patients, while others found no evidence that patients' anxiety is reduced or of any effect on pain or hospital stay) .
To our knowledge there was no study investigating the impact of preoperative counselling on postoperative agitation following nasal surgeries, The aim of our study to investigate the effect of preoperative educational counselling of the patient undergoing nasal surgery on emergence agitation .
- Conditions
- Postoperative Agitation
- Keywords
- agitation, counseling, nasal surgeries
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| - Group A | Will ask them to close their nose completely by their hands and take their breath only from the mouth for 2 to 3 minutes before induction of GA. : immediately after extubation we will tell them many times at their ear that the operation has been finished and ask them to take their breath from the mouth as they counselled and trained at preoperative period | |
| ● Group B | Will start the induction of anesthesia without any preoperative counselling of nasal closure . this group will undergo extubation and should be instructed to use their nose for breathing without Without preoperative counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of emergence agitation using AONO s scale(percentage of patients having score of 3 or 4)
● AONO s four point agitation scale The scale is decribed as 1 = calm; 2 = not calm but could be easily calmed; 3 = not easily calmed, moderately agitated or restless; and 4 = combative, excited, or disoriented.
Measured: scale immediately after extubation and then every 5 minutes for 20 minutes
Secondary outcomes (4)
heart rate in beats per minute
Measured: immediately after extubation and then every 5 minutes for 20 minutes
systolic blood pressure in mmhg
Measured: immediately after extubation and then every 5 minutes for 20 minutes
mean blood pressure in mmhg
Measured: immediately after extubation and then every 5 minutes for 20 minutes
oxygen saturation in %
Measured: immediately after extubation and then every 5 minutes for 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start25 Nov 2024
- Primary completion25 Oct 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AgitationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maged Abdel-Wahab Abdel-Aziz, Cairo University
- Investigators
- Maged aw el gendy, lecturer, Principal investigator, kaser al aini cairo universityMaged aw el gendy, lecturer, Principal investigator, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686511
- Sponsor's protocol ID
- counseling and agitation
- Status last verified
- Jan 2026
- First submitted
- 28 Oct 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing the results
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Counseling on Emergence Agitation in Patients Candidate for Nasal Surgeries : a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06686511
- Acronym / sponsor ID
- counseling and agitation
- Conditions
- Postoperative Agitation
- Keywords
- agitation, counseling, nasal surgeries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 25 Oct 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 13 Nov 2024 (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.
Emergence agitation is a post anesthetic phenomenon that develops in the early phase of general anesthesia recovery,The aim of our study to investigate the effect of preoperative educational counselling of the patient undergoing nasal surgery on emergence agitation .
Detailed description
While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children. Especially, our clinical impression is that nasal surgical patients admitted to the postbanesthesia care unit (PACU) have suffered emergence agitation more frequently than other surgical patients, possibly due to a sense of suffocation during emergence from anesthesia.
preoperative counselling and repeated verbal stimulation of orientation may serve as a simple and easily applicable strategy to reduce emergence agitation after general anaesthesia .
There have been studies looking into the effect of pre-operative counselling on individual aspects internationally like anxiety, BMI, serum cholesterol , length of stay , pain .( Six trials were identified and have produced conflicting findings. Some trials have demonstrated the effects of preoperative education on improving physical and psychosocial recovery of cardiac patients, while others found no evidence that patients' anxiety is reduced or of any effect on pain or hospital stay) .
To our knowledge there was no study investigating the impact of preoperative counselling on postoperative agitation following nasal surgeries, The aim of our study to investigate the effect of preoperative educational counselling of the patient undergoing nasal surgery on emergence agitation .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| - Group A | – | –Will ask them to close their nose completely by their hands and take their breath only from the mouth for 2 to 3 minutes before induction of GA. : immediately after extubation we will tell them many times at their ear that the operation has been finished and ask them to take their breath from the mouth as they counselled and trained at preoperative period |
| ● Group B | – | –Will start the induction of anesthesia without any preoperative counselling of nasal closure . this group will undergo extubation and should be instructed to use their nose for breathing without Without preoperative counselling |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I or II patients of both genders undergoing nasal surgery in the age between 21 to 65 years old will be included in the study
Key inclusion criteria (4 listed)
- Both genders.
- Patients undergoing nasal surgery
- American Society of Anesthesiologist (ASA) I or II physical status.
- Between 18 and 65 years of age.
Key exclusion criteria (8 listed)
- ● Patients with communication difficulties.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of emergence agitation using AONO s scale(percentage of patients having score of 3 or 4)
Time frame: scale immediately after extubation and then every 5 minutes for 20 minutes
● AONO s four point agitation scale The scale is decribed as 1 = calm; 2 = not calm but could be easily calmed; 3 = not easily calmed, moderately agitated or restless; and 4 = combative, excited, or disoriented.
4 secondary outcomes
heart rate in beats per minute
Time frame: immediately after extubation and then every 5 minutes for 20 minutes
systolic blood pressure in mmhg
Time frame: immediately after extubation and then every 5 minutes for 20 minutes
mean blood pressure in mmhg
Time frame: immediately after extubation and then every 5 minutes for 20 minutes
oxygen saturation in %
Time frame: immediately after extubation and then every 5 minutes for 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. sharing the results
Related trials for Postoperative Agitation
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruiting
Intranasal Dexmedetomidine Combined With Esketamine for Emergence Quality After Suspension Laryngoscopy
Emergence Agitation, Vocal Cord Polyps
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
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.
Maged aw el gendy, lecturer principal investigator
kaser al aini cairo university
Maged aw el gendy, lecturer principal investigator
university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Agitation, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 12 Jan 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 using AONO s scale(percentage of patients having score of 3 or 4) (time frame: scale immediately after extubation and then every 5 minutes for 20 minutes). 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 12 Jan 2026.