Anesthesia ComplicationPhase 4NCT05369819
Effect of Midazolam Premedication on Opioid-induced Mask Ventilation Difficulty
A Phase 4 study testing Midazolam and Saline in people with Anesthesia Complication, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia Complication
- What is being tested?
- Midazolam and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2022to 3 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class I and II patients
- Patients who are scheduled for any elective surgery under general anesthesia
Who cannot join
- 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
Show all 9Show fewer
- chronic use of opioid, benzodiazepine, antipsychotic medications
- pregnancy
- presence of muscle weakness or dyspnea
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman
About this study
Official title: Effect of Midazolam Premedication on Opioid-induced Mask Ventilation Difficulty During General Anesthesia Induction: A Randomized Clinical Trial
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.
Read the detailed description
American Society of Anesthesiologists (ASA) class I and II patients who are admitted to undergoing elective surgery under general anesthesia will be enrolled. Patients in midazolam group (Group M) will be treated with midazolam premedication (3 cc mixture of 0.035 mg/kg midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously in a waiting area 3 minutes before transportation to an operating room, while 3 cc normal saline will be administered to control group (Group S) patients. The difficulty of mask ventilation will be evaluated before the injection of neuromuscular blocking during general anesthetic induction. The anxiety and sedation levels of patients will be estimated before the intervention and before anesthetic induction in an operating room. Remifentanil will be used as an opioid in the induction of the patients. In anesthesia induction, propofol 1.5 mg/kg will be given after remifentanil is infused at a dose of 0.30 µg/kg/min for three minutes. Before the patients were given muscle relaxants, the patients were evaluated with the Warter scale
- Conditions
- Anesthesia Complication
- Being tested
- Midazolam, Saline
- Keywords
- premedication, midazolam, opioids, remifentanil, Anesthesia, General
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Group M
. 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
SalineDrug
Also called Group S
Control group patients are treated with 3 cc normal saline in a waiting area 3 minutes before transportation to an operating room
| Study group | Role | What they receive |
|---|---|---|
| Group M | Experimental | Patients of the Group M will be treated with midazolam premedication. Receives: Drug: Midazolam |
| Group S | Placebo comparator | Group S patients are treated with 3 cc normal saline. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery at 30 seconds after loss of consciousness
Secondary outcomes (2)
Anxiety level; Numerical Rating Scale(NRS) score (0 - 10)
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 to 10 integers) that best reflects the intensity of their anxiety (0= very calm, 10= very anxious).
Measured: 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)
Before the intervention in the waiting area, and 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.
Measured: One minute before the intervention in waiting area, and one minute before the anesthetic induction in operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start24 May 2022
- Primary completion2 Jan 2024
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafet Yarımoglu, MD, Principal investigator, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369819
- Sponsor's protocol ID
- 08-2021/14
- Status last verified
- Jun 2023
- First submitted
- 22 Apr 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Midazolam Premedication on Opioid-induced Mask Ventilation Difficulty During General Anesthesia Induction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05369819
- Acronym / sponsor ID
- 08-2021/14
- Conditions
- Anesthesia Complication
- Keywords
- premedication, midazolam, opioids, remifentanil, Anesthesia, General
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
American Society of Anesthesiologists (ASA) class I and II patients who are admitted to undergoing elective surgery under general anesthesia will be enrolled. Patients in midazolam group (Group M) will be treated with midazolam premedication (3 cc mixture of 0.035 mg/kg midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously in a waiting area 3 minutes before transportation to an operating room, while 3 cc normal saline will be administered to control group (Group S) patients. The difficulty of mask ventilation will be evaluated before the injection of neuromuscular blocking during general anesthetic induction. The anxiety and sedation levels of patients will be estimated before the intervention and before anesthetic induction in an operating room. Remifentanil will be used as an opioid in the induction of the patients. In anesthesia induction, propofol 1.5 mg/kg will be given after remifentanil is infused at a dose of 0.30 µg/kg/min for three minutes. Before the patients were given muscle relaxants, the patients were evaluated with the Warter scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M | Experimental | Drug: MidazolamPatients of the Group M will be treated with midazolam premedication. |
| Group S | Placebo comparator | Drug: SalineGroup S patients are treated with 3 cc normal saline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) class I and II patients
- Patients who are scheduled for any elective surgery under general anesthesia
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamAlso: Group M. 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 | Drug | Group M |
| SalineAlso: Group SControl group patients are treated with 3 cc normal saline in a waiting area 3 minutes before transportation to an operating room | Drug | Group S |
Primary outcome
Difficulty of mask ventilation (Warters grading scale 0-10)
Time frame: During surgery at 30 seconds after loss of consciousness
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.
2 secondary outcomes
Anxiety level; Numerical Rating Scale(NRS) score (0 - 10)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafet Yarımoglu, MD principal investigator
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam and Saline in people with Anesthesia Complication, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulty of mask ventilation (Warters grading scale 0-10) (time frame: During surgery at 30 seconds after loss of consciousness). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.