AnesthesiaNCT03241004
Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?
A study testing Sleep Mask in people with Anesthesia, run by Englewood Hospital and Medical Center at 1 site in United States.
Trial summary
This study aims to determine if anesthetic depth can be deepened non-pharmacologically through use of sleep masks. This study seeks to demonstrate a relationship between the depth of anesthesia with application of sleep masks intraoperatively and in the critical care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sleep Mask
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2017to 8 Jul 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years of age.
- Not pregnant.
Who cannot join
- Undergoing surgeries expected to last less than 3 hours.
- Undergoing vascular or neurosurgical procedures.
- Patients with history of CVA (Cardiovascular accidents or disease) or other neurological dysfunction.
- Patients or authorized representatives unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
About this study
This study aims to determine if anesthetic depth can be deepened non-pharmacologically through use of sleep masks. This study seeks to demonstrate a relationship between the depth of anesthesia with application of sleep masks intraoperatively and in the critical care setting.
Read the detailed description
Depth of anesthesia will be monitored, both with a standard sleep mask applied and without, in each subject using standard electroencephalogram (EEG) readings via forehead leads and Masimo Sedline 2.0 4-lead EEG monitors.
OR Subjects:
Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol and inhalational anesthetics will be used for maintenance of anesthesia. The standard electroencephalogram (EEG) reading via forehead leads and Masimo Sedline 2.0 4-lead EEG machines will be used to monitor the depth of anesthesia, both with and without the sleep mask.
ICU Subjects:
Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol will be used for maintenance of anesthesia. The standard electroencephalogram (EEG) reading via Masimo Sedline 2.0 4-lead EEG monitors will be used to track the depth of anesthesia, both with and without the sleep mask.
All Subjects:
In both settings,once baseline EEG readings are established (30 minutes), EEG data will be recorded and a sleep mask will be applied to the patient for one hour. After one hour (90 minutes), EEG data will be recorded and the sleep mask will be removed. After another hour (150 minutes), EEG data will be recorded and the mask reapplied. After another hour (210 minutes), EEG data will be recorded and the mask removed. The levels/doses of anesthetic agent at each time point will also be recorded.
Subjective perception of depth of anesthesia will be obtained by means of a post-procedure evaluation administered to each subject.
- Conditions
- Anesthesia
- Being tested
- Sleep Mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep MaskOther
sleep mask applied for two separate 60-minute periods during anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Intensive Care Unit | Experimental | Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol will be used for maintenance of anesthesia.
Baseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded. Receives: Other: Sleep Mask |
| Operating Room | Experimental | Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol and inhalational anesthetics will be used for maintenance of anesthesia.
Baseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded. Receives: Other: Sleep Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG data
change in depth of anesthesia from baseline to two hours
Measured: 2 hours
Secondary outcomes (1)
Subject perception of depth of anesthesia
post-procedure evaluation
Measured: within 24 hours of reversal of sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start7 Jul 2017
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Why it stopped: change in study staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Smok, MD, Principal investigator, Englewood Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241004
- Sponsor's protocol ID
- E-17-705
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2017
- Last updated
- 20 Aug 2021
- 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 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)?
- ClinicalTrials.gov ID
- NCT03241004
- Acronym / sponsor ID
- E-17-705
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in study staffing
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 7 Aug 2017 (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.
This study aims to determine if anesthetic depth can be deepened non-pharmacologically through use of sleep masks. This study seeks to demonstrate a relationship between the depth of anesthesia with application of sleep masks intraoperatively and in the critical care setting.
Detailed description
Depth of anesthesia will be monitored, both with a standard sleep mask applied and without, in each subject using standard electroencephalogram (EEG) readings via forehead leads and Masimo Sedline 2.0 4-lead EEG monitors.
OR Subjects:
Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol and inhalational anesthetics will be used for maintenance of anesthesia. The standard electroencephalogram (EEG) reading via forehead leads and Masimo Sedline 2.0 4-lead EEG machines will be used to monitor the depth of anesthesia, both with and without the sleep mask.
ICU Subjects:
Patients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol will be used for maintenance of anesthesia. The standard electroencephalogram (EEG) reading via Masimo Sedline 2.0 4-lead EEG monitors will be used to track the depth of anesthesia, both with and without the sleep mask.
All Subjects:
In both settings,once baseline EEG readings are established (30 minutes), EEG data will be recorded and a sleep mask will be applied to the patient for one hour. After one hour (90 minutes), EEG data will be recorded and the sleep mask will be removed. After another hour (150 minutes), EEG data will be recorded and the mask reapplied. After another hour (210 minutes), EEG data will be recorded and the mask removed. The levels/doses of anesthetic agent at each time point will also be recorded.
Subjective perception of depth of anesthesia will be obtained by means of a post-procedure evaluation administered to each subject.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Care Unit | Experimental | Other: Sleep MaskPatients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol will be used for maintenance of anesthesia. Baseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded. |
| Operating Room | Experimental | Other: Sleep MaskPatients will be induced in a standard fashion using intravenous (IV) anesthetics. A continuous administration of propofol and inhalational anesthetics will be used for maintenance of anesthesia. Baseline EEG readings will be established for 30 minutes, then EEG data will be recorded and a sleep mask applied to the patient for one hour. After one hour, eye masks will be removed for an hour and reapplied after another hour. During the hour that the mask is off, 2 hours into sedation, EEG data will again be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female at least 18 years of age.
- Not pregnant.
Key exclusion criteria (4 listed)
- Undergoing surgeries expected to last less than 3 hours.
- Undergoing vascular or neurosurgical procedures.
- Patients with history of CVA (Cardiovascular accidents or disease) or other neurological dysfunction.
- Patients or authorized representatives unable or unwilling to provide informed consent.
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 |
|---|---|---|
| Sleep Masksleep mask applied for two separate 60-minute periods during anesthesia | Other | Intensive Care Unit, Operating Room |
Primary outcome
EEG data
Time frame: 2 hours
change in depth of anesthesia from baseline to two hours
1 secondary outcome
Subject perception of depth of anesthesia
Time frame: within 24 hours of reversal of sedation
Results and safety
The study was stopped early (reason given: change in study staffing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Related InfoLink provided by the sponsor.
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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.
Jeff Smok, MD principal investigator
Englewood Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Mask in people with Anesthesia, run by Englewood Hospital and Medical Center at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 20 Aug 2021. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: change in study staffing). Results are not available in the source record.
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?
EEG data (time frame: 2 hours). 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 20 Aug 2021.