Effect of Midazolam Premedication on Mask Ventilation Difficulty

December 7, 2022 updated by: Karaman Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Karaman, Turkey
        • Karaman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Midazolam-Group M
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
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
Placebo Comparator: Control- Group S
Control group patients are treated with 3 cc normal saline at waiting area 3 minutes before transportation to an operating room.
Drug: Saline
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At 30 seconds after loss of consciousness

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
One minute before the intervention in waiting area, and one minute before the anesthetic induction in operating room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karaman Training and Research Hospital

Investigators

  • Principal Investigator: Rafet Yarımoglu, MD, Karaman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2022

Primary Completion (Actual)

December 7, 2022

Study Completion (Actual)

December 7, 2022

Study Registration Dates

First Submitted

May 6, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 10, 2022

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-2021/13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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