Effect of Midazolam Premedication on Mask Ventilation Difficulty

NCT05368441 | Completed Phase 4

• 1 other identifier: 08-2021/13
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia Complication

Keywords

premedication; midazolam; anesthesia,general

Outcome Measures

Primary Outcomes (1)

• Difficulty of mask ventilation (Han's grading scale)

  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)

  At 30 seconds after loss of consciousness

Secondary Outcomes (2)

• Anxiety level, mYPAS (0-100)

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

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

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

Study Arms (2)

Midazolam-Group M

EXPERIMENTAL

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.

Drug: Midazolam

Control- Group S

PLACEBO COMPARATOR

Control group patients are treated with 3 cc normal saline at waiting area 3 minutes before transportation to an operating room.

Drug: Saline

Interventions

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.

Also known as: Group M

Midazolam-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.

Also known as: Group S

Control- Group S

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

Location

Related Publications (1)

• Yarimoglu R, Basaran B, Et T, Bilge A, Korkusuz M. Midazolam premedication facilitates mask ventilation in children during propofol induction of anesthesia: a randomized clinical trial. BMC Anesthesiol. 2025 Mar 18;25(1):131. doi: 10.1186/s12871-025-03002-4.

  PMID: 40102763 DERIVED

MeSH Terms

Interventions

Midazolam; Sodium Chloride

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Rafet Yarımoglu, MD

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 10, 2022
• Study Start: May 24, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-05

Locations

TU (1)