Effects of intravenous dexmedetomidine and intravenous Apotel and combined of those (intravenous Apodex) on postoperative emergence agitation & pai

Phase 2

Recruiting

• Conditions: Adenotonsilectomy.; Hypertrophy of tonsils with hypertrophy of adenoids

• Registration Number: IRCT2016092930049N1
• Lead Sponsor: Vice chancellor for research of Kurdistan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 132

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 apenea (OSA)

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Emergence agitation. Timepoint: 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. Method of measurement: five score criteria described by Col for evaluate emergence agitation.;Pain. Timepoint: 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. Method of measurement: modified 10 score TPPPS criteria for evaluate of pain in children.

Secondary Outcome Measures

Name	Time	Method
Delirium. Timepoint: 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. Method of measurement: 20 score PAED criteria for evaluate delirium in children.;Time to need the first rescue analgesic dose. Timepoint: Period of time from PACU admitance until the first need to analgesics. Method of measurement: By recording period of time between PACU admitance to the first need to analgesics.;Rate of need to analgesics. Timepoint: amount of analgesics usage for pain & EA relief. Method of measurement: By recording of amounts of analgesic usage in PACU & ward.;Nausea & vomiting. Timepoint: consideration for beeing Nausea & vomiting. Method of measurement: Have or not have.;Time of stay in PACU. Timepoint: Period of time from admitance to discharge from PACU. Method of measurement: recording period of time from admitance to discharge from PACU based on Aldrete criteria > 9.