Effect of Midazolam Premedication on Opioid-induced Mask Ventilation Difficulty

NCT05369819 | Completed Phase 4

• 1 other identifier: 08-2021/14
• 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. Opioid-derived drugs used in anesthesia induction may cause difficulty in mask ventilation due to their chest wall rigidity and respiratory depressant effects. Adequate muscle relaxation and depth of anesthesia may assist with mask ventilation. It is known that premedication reduces anxiety and 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, the investigators will evaluate the effect of midazolam premedication on the mask ventilation after induction with remifentanil.

Conditions

Anesthesia Complication

Keywords

premedication; midazolam; opioids; remifentanil; Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Difficulty of mask ventilation (Warters grading scale 0-10)

  The difficulty of mask ventilation will be assessed after 30 seconds from propofol induction (loss of consciousness) with Warter's scale. The Warters scale assigns points based on escalating levels of intervention necessary to ventilate the lungs such as the use of an airway device, increased inspiratory pressure, and two-person ventilation, which are all intended to overcome upper airway resistance to ventilation. Additionally, the Warters scale accounts for situations in which a poor quality mask seal inhibits mask ventilation. Thus, in the event that the target tidal volume of 5 ml/kg is not achieved, and the provider is unable to generate a peak inspiratory pressure of \>30 cmH20, additional points are assigned. The scale is scored between 0-10 and higher scores indicate worse mask application.

  During surgery at 30 seconds after loss of consciousness

Secondary Outcomes (2)

• Anxiety level; Numerical Rating Scale(NRS) score (0 - 10)

  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)

Group M

EXPERIMENTAL

Patients of the Group M will be treated with midazolam premedication.

Drug: Midazolam

Group S

PLACEBO COMPARATOR

Group S patients are treated with 3 cc normal saline.

Drug: Saline

Interventions

Midazolam DRUG

. Patients of the midazolam group will be treated with midazolam premedication (3 cc mixture of 0.035 mg/kg midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously a waiting area 3 minutes before transportation to an operating room

Also known as: Group M

Group M

Saline DRUG

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

Also known as: Group S

Group S

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) class I and II patients
• Patients who are scheduled for any elective surgery under general anesthesia

You may not qualify if:

• age \<18 or \>60 years
• current cervical spine disease or history of cervical spine surgery;
• morbid obesity (body mass index, ≥35 kg/m2);
• sleep apnea;
• craniofacial anomaly;
• allergic reaction to midazolam and remifentanil
• chronic use of opioid, benzodiazepine, antipsychotic medications
• pregnancy
• presence of muscle weakness or dyspnea

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

Location

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
• Masking 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 11, 2022
• Study Start: May 24, 2022
• Primary Completion: January 2, 2024
• Study Completion: January 3, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-06

Locations

TU (1)