Emergence Agitation
Conditions
Keywords
Emergence agitation, septoplasty surgeries, micro-dose Dexmedetomidine
Brief summary
This prospective randomized controlled study will be conducted to evaluate the effect of preoperative single, micro-dose of dexmedetomidine (0.3μg/kg) on the incidence and severity of EA in adults undergoing Septoplasty surgeries
Detailed description
Emergence agitation (EA) is characterised by confusion, restlessness or aggressive behaviour during recovery from general anaesthesia. EA is more common following ear, nose, & throat (ENT) surgery. The exact cause and pathophysiology of EA are unknown, although risk factors include preschool age, preoperative anxiety, postoperative pain, nausea, vomiting, otolaryngology operations, and the use of inhalational anesthetics particularly sevoflurane. EA might cause injury, accidental removal of intravenous cannulation, self-extubation, post-operative wound bleeding and increase the nursing requirements in the post-anesthesia care unit (PACU). There are limited studies concerning adult EA, and although its prevalence is less than child EA, it carries more risk of injury due to serious uncontrolled behaviors. Intravenous (IV) anesthetics, sedatives and opioids are the most frequently utilized medications to manage EA, with variable success rates and significant potential to delay recovery and cause undesirable side-effects. Dexmedetomidine is a highly selective α2 agonist which produces sedation and anxiolysis through reduction in sympathetic central nervous system activity. It has a major advantage over other sedatives; it is associated with minimal respiratory depression. According to a recent meta-analysis, intraoperative administration of dexmedetomidine decreases postoperative pain and the incidence of EA in adults. Considering the short length of corrective nasal reduction surgery (CR), an intraoperative infusion of dexmedetomidine as an anesthetic adjuvant may prolong the anesthesia and recovery time. Low dose infusion of dexmedetomidine (0.2 µg /kg/h) has been reported to reduce incidence of EA and opioid consumption effectively in elderly patients undergoing cancer surgeries under GA. Previous studies have shown that a single dose of dexmedetomidine, not as a premedication, is also effective in reducing EA and facilitating smooth extubation after pediatric adenotonsillectomy. Also recent study reported the efficacy of pre-operative dexmedetomidine administration (1 μg/kg) in preventing EA in adults undergoing CR of a nasal bone fracture. Up till now no clinical studies investigated the efficacy of single pre-operative micro dose of dexmedetomidine in prevention of EA, so in this clinical study we hypothesize that preoperative micro dose of dexmedetomidine may be beneficial in mitigation of EA in short timed Septoplasty surgeries safely and without prolongation of recovery time.
Interventions
DRUGDexmedetomidine
micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.
DRUGSaline
50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients of both gender aged 18 to 60 years with American Society of Anesthesiologists (ASA) Physical Status I or II, who were scheduled for septoplasty surgery under general anesthesia.
Exclusion criteria
* Patients declined to participate in the trial. * History or clinical evidence of chronic obstructive pulmonary disease. * History of renal or hepatic dysfunction, sleep apnea syndrome. * Cognitive dysfunction or psychiatric disorder. * Patients receiving beta blocker. * Patients with anticipated difficult airway. * Patients with electro cardiac abnormalities. * Emergency surgeries. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of emergence agitation | incidence of emergence agitation will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery. | using Aono's Four-Point Scale (Aono Scale) which is a simple and widely used tool to assess emergence agitation (EA). It categorizes agitation during emergence from anesthesia into four levels. 1. calm\_ Patient is quiet and not agitated. 2. Not calm but can be easily consoled \_ Slight restlessness but settles with verbal reassurance or mild physical comfort. 3. Moderately agitated \_ Patient is crying or difficult to console but not combative. 4. Severely agitated \_Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff. Scores 3-4 indicate clinically relevant emergence agitation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| severity of emergence agitation | severity of EA will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery. | Aono's Scale grades the intensity of a patient's agitation during emergence from anesthesia (3) Moderately agitated - Patient is crying or difficult to console but not combative. (4) Severely agitated - Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff. |
| extubation time | Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT). | Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT). |
| Length of stay in the post anesthetic care unit (PACU). | time from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward | Total time a patient spends in the PACU from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward |
| Intraoperative opioid consumption | from induction of anesthesia until completion of surgery | Total amount of opioid medications administered to a patient during the entire surgical procedure, from induction of anesthesia until completion of surgery |
| Post operative numerical rating scale score (NRS) | - NRS score is measured at PACU arrival and every 15 minutes for 1 hour after surgery | The Numerical Rating Scale (NRS) is a validated tool used to assess a patient's pain intensity by having them assign a number to their pain on a 0-10 scale. On a scale from 0 to 10, where 0 means no pain and 10 is the worst pain imaginable |
Countries
Egypt
Outcome results
None listed