Clinical trial NCT06686511: The Effect of Preoperative Counseling on Emergence Agitation in Patients Candidate for Nasal Surgeries
Official title: The Effect of Preoperative Counseling on Emergence Agitation in Patients Candidate for Nasal Surgeries : a Prospective Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Agitation
Keywords: agitation
counseling
nasal surgeries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 256
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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 .

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 .

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* ● 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)

Primary outcomes:
measure: The incidence of emergence agitation using AONO s scale(percentage of patients having score of 3 or 4)
timeFrame: scale immediately after extubation and then every 5 minutes for 20 minutes
Secondary outcomes:
measure: heart rate in beats per minute
timeFrame: immediately after extubation and then every 5 minutes for 20 minutes
measure: systolic blood pressure in mmhg
timeFrame: immediately after extubation and then every 5 minutes for 20 minutes
measure: mean blood pressure in mmhg
timeFrame: immediately after extubation and then every 5 minutes for 20 minutes
measure: oxygen saturation in %
timeFrame: immediately after extubation and then every 5 minutes for 20 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: operating ENT theater kasr alaini hospital
state: Manil
Study officials:
affiliation: kaser al aini cairo university
name: Maged aw el gendy, lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: university
name: Maged aw el gendy, lecturer
role: PRINCIPAL_INVESTIGATOR
References: