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Completed

NCT Number: NCT05368441

Effect of Midazolam Premedication on Mask Ventilation Difficulty

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.

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Key information

Conditions

Anesthesia Complication

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 2< and <10 children
  • American Society of Anesthesiologists (ASA) class I and II
  • Children who are scheduled for any elective surgery under general anesthesia

Exclusion criteria

  • age <2 or >10 years;
  • obesity (body mass index, ≥35 kg/m2);
  • craniofacial anomaly;
  • allergic reaction to midazolam;
  • presence of muscle weakness or dyspnea.
  • children posted for any emergency procedure,
  • above ASA class II
  • children with abnormal airway anatomy,
  • children with active respiratory infection in the last 3 weeks,
  • children with a past history of chronic respiratory disorder,
  • children who are being treated with sedative or anticonvulsive agents

Treatment and study plan

midazolam

Drug

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.

Other names: Group M

Saline

Drug

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 names: Group S

Primary outcomes

  1. Difficulty of mask ventilation (Han's grading scale)

    Time frame: At 30 seconds after loss of consciousness

    The Han's scale is a four point grading scale, assigns points based on escalating levels of intervention necessary to ventilate the lungs such as the use of an airway device, two-person ventilation, which are all intended to overcome upper airway resistance to ventilation. (1 point: Easy mask ventilation, 4 point: Impossible - unable to mask ventilate)

Secondary outcomes

  1. Anxiety level, mYPAS (0-100)

    Time frame: One minute before the intervention in waiting area, and one minute before the anesthetic induction in operating room

    The modified Yale Preoperative Anxiety Scale (mYPAS) is an observational measure of children's preoperative anxiety consisting of 27 items divided into 5 categories: Activity, Vocalizations, Emotional Expressivity, State of Arousal and Use of Parent. Scores range from 22.5 to 100 with higher scores indicating greater anxiety.

  2. Sedation level (Modified Observer's assessment of alertness/sedation (MOAA/S) scale)

    Time frame: One minute before the intervention in waiting area, and one minute before the anesthetic induction in operating room

    One minute before the intervention in the waiting area, and one minute before the anesthetic induction in the operating room sedation levels were evaluated with MOAA/S scale. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale was developed to measure the level of alertness in subjects who are sedated. The Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scale is frequently used in sedation-related drug and device studies to assess a subject's level of sedation. The MOAA/S ranges from 0 to 5, with a score of 5 defined as awake or minimally sedated, and a score of 0 defined as general anesthesia.

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

Effect of Midazolam Premedication on Mask Ventilation Difficulty During General Anesthesia Induction in Children: A Randomized Clinical Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 10, 2022
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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