(1) Objectives: Evaluation of the effects of intravenous dexmedetomidine and intravenous Apotel and combined of those (intravenous Apodex) on postoperative emergence agitation & pain after adenotonsilectomy in children
(2) Design: randomized, double blind controlled with placebo.
(3) Setting and conduct: After set up monitoring & fixation of venous catheter & infusion of serum crystalloid, all patients will be received 0.5 mg/kg dexamethazone, 1 µg/kg fentanyl, 0.02 mg/kg atropine as premedication. subsequently induction of anesthesia will be applied with 2 mg/kg propofol & 1 mg/kg succynylcolin, then patients will be intubated. maintenance of anesthesia until to the end of surgery will be continued with combination of 50% oxygen, 50% nitrous oxide, and 2-3% of sevoflurane concentration.
(4) Participants including major eligibility criteria. Inclusion criteria: take Informed consent from parents to enter the study; patients between 2-12 old age candidate for :Adenotonsilectomy; Physical status 1 and 2 classification of "American Society of Anesthesiologists" (ASA).
Exclusion criteria: History of any cardiac, kidney, hepatic, or neurologic (convulsion) disease; Respiratory disease (Asthma or respiratory allergy); History of allergic reaction to the study drugs; History of upper airway infection in the last 4 weeks; use of any type of sedative drugs at the night before surgery; evidence of severe obstractive sleep apnea (OSA)
Sample size: 132 person.
(5) Intervention: Patients will be received 15 mg/kg Apotel in 50 ml normal saline in group A, 1 mcg/kg dexmedetomidine in 50 ml normal saline in group D, 10 mg/kg Apotel and 0.3 mcg/kg dexmedetomidine in 50 ml normal saline in group AD, and merely 50 ml normal saline in group S or control group just 15 minutes before termination of surgery during 10 minutes.
(6) Main outcome measures: when patient is transferred to postanesthesia care unit (PACU), emergence agitation (EA) using five score (Col et al) criteria, and pain using 10 score TPPPS criteria will be measured and recorded in advent to the recovery room (T0) and in 5,15,30 minutes thereafter and when the patient discharge from PACU. As well as 6 and 24 hours after discharge from PACU the proportion of EA & pain will be measured and recorded in the ward using aforementioned criteria.
patient discharge from PACU will be based on Aldrete 10 score criteria.
patient with Aldrete score > 9, and when do not have nausea and vomiting, and with controlled EA & pain will be discharged from PACU, and the time of stay in PACU will be recorded.