Clinical trial

Effect of Midazolam Premedication on Opioid-induced Mask Ventilation Difficulty During General Anesthesia Induction: A Randomized Clinical Trial

Name

08-2021/14

Description

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.

Trial arms

Trial start

2022-05-24

Estimated PCD

2024-01-02

Trial end

2024-01-03

Status

Completed

Phase

Early phase I

Treatment

Midazolam

. 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

Arms:

Group M

Other names:

Group M

Saline

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

Arms:

Group S

Other names:

Group S

Size

120

Primary endpoint

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

During surgery at 30 seconds after loss of consciousness

Eligibility criteria

Inclusion Criteria: * American Society of Anesthesiologists (ASA) class I and II patients * Patients who are scheduled for any elective surgery under general anesthesia Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}

Updated at

2024-01-05

1 organization

1 product

1 drug

1 indication

Organization

Karaman Training and Research Hospital

Product

Midazolam

Indication

Anesthesia Complications

Drug

Varlilumab