Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries
Condition: Agitation, Emergence
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Early Phase 1

Summary: 
      -  emergence agitation is seen in around 68% after nasal surgeries. Agitated patients needs
           more staff and nurses to control their abnormal movement which leads to self extubation
           , removal of catheters and bruises in the extremities.

        -  Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to
           prevent EA . Recently, ketodex is found to reduce the incidence and severity of EA .

        -  We aim to compare single bolus dose of Ketodex Versus Ketofol For Prevention Of
           emergence Agitation in adults undergoing nasal surgeries.
    

Detailed description: 
      The incidence of emergence agitation (EA) after nasal surgeries is relatively high , it is
      reported to be 68% (1).The precise mechanism is not known. Awake extubation after nasal
      surgeries is preferred as the airway may be contaminated by blood , and the nasal airway may
      be blocked by surgical packs that causes sense of suffocation. Awake extubation and nasal
      pack is a trigger to emergence agitation(2).

      emergence agitation (EA) is harmful to the patient and the staff, it Characterized by
      disorientation, confusion, abnormal violent movement that may result in serious complication
      and morbidity(3). It develops early with the recovery from general anesthesia(4). Although
      agitation is more observed in pediatrics but its incidence in adults reach up to 21.4% (5).

      Different medication agents such as anesthetic drugs, benzodiazepine and α2 agonist was
      proved to attenuate the EA with different efficiencies (6).

      Dexmedetomidine is a selective α2 adrenoceptor agonist. It has sedative, hypnotic,
      anxiolytic, analgesic and sympatholytic properties. It was proved to reduce the EA in
      children(7). However there was few data about its effect in reducing the agitation in adult
      after general anesthesia(8).

      Propofol is short acting hypnotic and sedative agent. It is used for induction and
      maintenance of anesthesia(9). Previous studies proved that propofol was effective in
      preventing EA (10,11) and depends on the time of administration(12).

      Ketamine is N-methyl- D-asparate receptor antagonist, it has anesthetic, sedative and
      analgesic effect(13).

      Ketofol is a combination of low dose ketamine with propofol , it has been used for sedation
      and analgesia. The effect of this combination was supposed to produce less toxicity compared
      to each drug alone by decreasing the required doses(14).

      Ketodex is combined low dose of ketamine and dexmedetomidine, it was used for sedation , this
      combination decrease some of the pitfalls occurring when use dexmedetomidine as a sole
      agent(15).

      Most EA studies was done in pediatric. To our knowledge there was no previous studies report
      the effect of bolus dose of ketodex versus ketofol on the incidence and prevention of EA
      after nasal surgeries in adults. This study aimed to compare single bolus dose of Ketodex
      Versus Ketofol For Prevention Of Emergence Agitation In adults Undergoing nasal surgeries.
    

Intervention name(s): "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
Intervention type(s): Drug
Intervention description(s): patients will receive single intravenous bolus of combination from ketamine 0.5mg/kg and dexmedetomidine 1ug/kg in one syringe diluted in 10 ml 0.9% saline.
Other intervention name(s): ketalar; precedex; diprivan
Intervention MeSH terms: Dexmedetomidine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ketodex, ketofol , agitation , nasal surgery