The Effect of Preoperative Counseling on Emergence Agitation in Patients Candidate for Nasal Surgeries

NCT06686511 | Completed DMC

• 1 other identifier: counseling and agitation
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Postoperative Agitation

Keywords

agitation; counseling; nasal surgeries

Outcome Measures

Primary Outcomes (1)

• 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.

  scale immediately after extubation and then every 5 minutes for 20 minutes

Secondary Outcomes (4)

• heart rate in beats per minute

  immediately after extubation and then every 5 minutes for 20 minutes

• systolic blood pressure in mmhg

  immediately after extubation and then every 5 minutes for 20 minutes

• mean blood pressure in mmhg

  immediately after extubation and then every 5 minutes for 20 minutes

• oxygen saturation in %

  immediately after extubation and then every 5 minutes for 20 minutes

Study Arms (2)

- 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

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• Both genders.
• Patients undergoing nasal surgery
• American Society of Anesthesiologist (ASA) I or II physical status.
• Between 18 and 65 years of age.

You may not qualify if:

• ● 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

operating ENT theater kasr alaini hospital

Cairo, Manil, 1234, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psychomotor Agitation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Maged aw el gendy, lecturer

  kaser al aini cairo university

  PRINCIPAL INVESTIGATOR

• Maged aw el gendy, lecturer

  university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pricipal investigator

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 13, 2024
• Study Start: November 25, 2024
• Primary Completion: October 25, 2025
• Study Completion: November 15, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

EG (1)