Effect of Midazolam Premedication on Mask Ventilation Difficulty
Condition: Anesthesia Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      Mask ventilation has great importance during anesthesia induction because it is the only way
      to oxygenate patients who have lost consciousness and spontaneous breathing. Adequate muscle
      relaxation and depth of anesthesia may assist with mask ventilation. It is known that
      premedication to reduce anxiety has a relaxing effect on airway muscles. Midazolam is
      frequently used in premedication because it has a rapid onset of action and does not cause
      hemodynamic changes. In addition, midazolam may relax the airway by acting directly on the
      airway smooth muscle and thus facilitate mask ventilation during anesthesia induction. In
      this study, we will conduct a randomized controlled trial to evaluate the effect of midazolam
      premedication on facilitating mask ventilation in children.
    

Detailed description: 
      American Society of Anesthesiologists (ASA) class I and II patients aged 2-10 years who are
      scheduled for any elective surgery under general anesthesia will be enrolled. Patients in
      midazolam group will be treated with midazolam premedication (3 cc mixture of 0.1 mg/kg
      midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously at waiting area 3
      minutes before transportation to an operating room, while 3 cc normal saline will be
      administered to control group patients. Difficulty of mask ventilation during induction of
      general anesthesia will be evaluated with the Han Mask Scale. Muscle relaxants will be given
      for intubation after evaluation. The anxiety and sedation level of patients will be estimated
      one minute before the intervention and one minute before anesthetic induction in an operating
      room.

      Interventıon descriptıon Patients enrolled in this study are randomly allocated to midazolam
      group or control group. Total 120 patients will be enrolled. Each group consists of 60
      patients. Patients of midazolam group will be treated with midazolam premedication (3 cc
      mixture of 0.1 mg/kg midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously
      at waiting area 3 minutes before transportation to an operating room. Control group patients
      are treated with 3 cc normal saline at waiting area 3 minutes before transportation to an
      operating room. In anesthesia induction, propofol 2 mg/kg will be given. Before the patients
      were given muscle relaxants, the patients were evaluated with the Han's mask scale.
    

Intervention name(s): Midazolam; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Patients of midazolam group will be treated with midazolam premedication (3 cc mixture of 0.1 mg/kg midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously at waiting area 3 minutes before transportation to an operating room. In anesthesia induction, propofol 2 mg/kg will be given.Before the patients were given muscle relaxants, the patients were evaluated with the Han scale.; Control group patients are treated with 3 cc normal saline at waiting area 3 minutes before transportation to an operating room. In anesthesia induction, propofol 2 mg/kg will be given. Before the patients were given muscle relaxants, the patients were evaluated with the Han's grading scale.
Other intervention name(s): Group M; Group S
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be unaware of the group assignments and monitored in the reception area by a blinded anesthesiologist who will be in charge of the intervention and the evaluation of anxiety and sedation levels.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: premedication; midazolam; anesthesia,general