Emergence Agitation
Conditions
Keywords
emergence agitaion, Propofol, Dexmedetomidine, Rhinoplasty
Brief summary
To compare of prevention of emergence agitation in rhinoplasty with subanesthetic propofol and single dose dexmedetomidine
Detailed description
The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 80 patients planned for elective rhinoplasty, aged 18-65 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each. All cases will receive routine preparation for general anesthesia. For anesthesia induction 0,03 mg/kg midazolam, 2 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be used. Anesthesia will be maintained with 60% air, 40% oxygen and 1 MAC sevoflurane. If intraoperatively needed, an additional dose of 0.5 mcg/kg fentanyl and 0.15 mg/kg rocuronium will be administered. If necessary, nicardipine infusion will be administered to provide controlled hypotension. Before the end of the surgery, 15 mg/kg paracetamol and 1 mg/kg tramadol will be administered for postoperative analgesia. After the nasal tampons are placed, one group will receive 0.5 mg/kg propofol, and the other group will receive 0.5 mcg/kg dexmedetomidine IV infusion over 10 minutes. 4 mg/kg sugammadex will be administered as a muscle relaxant reversal agent. The patient will be extubated when spontaneous breathing occurs and the patient opens their eyes with verbal stimulation. Agitation status will be assessed with the Richmond Agitation Sedation Scale (RASS) at 1 minute after extubation. Heart rate, systolic, diastolic, mean arterial pressures and saturation values will also be recorded before and after anesthesia induction, at the 5th, 10th, 15th, 20th, 25th, 30th minutes after intubation, at the 1st, 5th, 10th and 15th minutes after extubation. Additionally, if meaningless head and hand-arm movements, laryngospasm, nausea-vomiting, hypoxia (SpO2: \<85%) occur at the 1st, 5th, 10th and 15th minutes after extubation, they will be recorded. Also recovery time will be recorded. All data will be recorded and statistical analysis will be made.
Interventions
DRUGDexmedetomidine
In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing
DRUGPropofol
In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
80 patients scheduled for rhinoplasty will be randomly assigned to two groups. After nasal packing placement, one group will receive intraoperative 0.5 mg/kg propofol, while the other group will receive 10-minute infusion of 0.5 mcg/kg dexmedetomidine.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for rhinoplasty * Between 18-65 years * ASA I-II group
Exclusion criteria
* Those who are outside the age range of 18-65 * Those who are ASA III and above * Those with renal,hepatic, cardiac and respiratory diseases * Those with a known allergy to the medication to be used * Those who underwent urinary catheterization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agitation status | 1. minute after extubation | The effect on prevention of emergence agitation of propofol and dexmedetomidine will be evaluated by an anaesthetist with the Richmond Agitation Sedation Scale (RASS) at 1 minute after extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | perioperatively defined times | Heart rate will be measured pre-induction of anesthesia, post-induction of anesthesia, 5th, 10th, 15th minutes after intubation, during extubation, 1st, 5th, 10th, 15th minutes after extubation |
| Blood Pressure | perioperatively defined times | Systolic blood pressure, diastolic blood preesuure, mean arterial pressure will be measured pre-induction of anesthesia, post-induction of anesthesia, 1st, 5th, 10th, 15th minutes after intubation, during extubation, 5th, 10th, 15th minutes after extubation |
| oxygen saturation | perioperatively defined times | Oxygen saturation will be measured pre-induction of anesthesia, post-induction of anesthesia, 5th, 10th, 15th minutes after intubation, during extubation, 1st, 5th, 10th, 15th minutes after extubation |
Countries
Turkey (Türkiye)
Contacts
Primary ContactMehmet Emin Keskin, assistant professor
Backup ContactBedrettin Bingöl, MD
Outcome results
None listed