Music, Anesthetic, InductionMUSINDUCNCT03941847
Evaluation of the Effect of Musical Listening on Hypnotic Savings During the Induction of General Anesthesia
A study testing music in people with Music, Anesthetic, Induction, run by University Hospital, Caen at 1 site in France.
Trial summary
Anesthetic induction requires the use of, among other things, hypnotic drugs that can lead to hemodynamic disorders, postoperative cognitive dysfunctions and delayed awakening. A strategy to reduce the doses of hypnotics administered could improve patients' postoperative outcomes and is part of the current strategy of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Music, Anesthetic, Induction
- What is being tested?
- music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2019to 31 Aug 2019
- 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
- Patient presenting for surgery under general anesthesia in ophthalmic surgery, ENT, CMF and neurosurgery (lumbar and cervical disc hernia, neurostimulator insertion, vertebral cementoplasty)
- Score ASA 1, 2, 3.
- Intervention time < 3 hours.
Who cannot join
- Patients under 18 years of age
- Patient under guardianship or curatorship
- Refusal of the patient
- Deaf patient
- Non-cooperating patient
- Anesthetic protocol different from that standardised
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Musinduc : Impact of Music During the Period of Anaesthetic Induction - a Randomized Controlled Clinical Trial
Anesthetic induction requires the use of, among other things, hypnotic drugs that can lead to hemodynamic disorders, postoperative cognitive dysfunctions and delayed awakening. A strategy to reduce the doses of hypnotics administered could improve patients' postoperative outcomes and is part of the current strategy of accelerated postoperative rehabilitation. Music has shown its effectiveness in reducing the doses of hypnotics administered during sedation procedures.
Objective :
Read more
We propose a study of this anesthetic period evaluating the effectiveness of music as an adjuvant agent for anesthetic drugs allowing hypnotic savings.
Materials and methods :
Randomized, prospective, monocentric study
2 groups will be compared. The experimental group will benefit from musical listening during the induction period of the anesthesia. The control group will have a usual care.
The primary endpoint is the amount of hypnotic (propofol®) used during anesthesia induction. The main secondary criteria are the duration of induction, the cost of induction, and the postoperative pain score and the proportion of patients with postoperative nausea and vomiting.
This study should include 104 subjects (52 in each group) requiring general anesthesia.
Hypothesis tested:
Listening to music reduces the amount of hypnotic product used in the induction of anesthesia by 0.5 mg/kg.
- Conditions
- Music, Anesthetic, Induction
- Being tested
- music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
listening music
| Study group | Role | What they receive |
|---|---|---|
| music | Experimental | The experimental group will benefit from musical listening during a classic period of induction of anesthesia Receives: Other: music |
| silence | No intervention | The control group will have a usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantity of propofol
quantity of propofol in mg/kg necessary for the induction of general anaesthesia
Measured: 2 months
Secondary outcomes (1)
Quantity of morphinomimetics
Quantity of morphinomimetics (morphine equivalent) used in mg for anesthetic induction.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start6 May 2019
- Primary completion30 Jun 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music, Anesthetic, InductionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups will be compared. The experimental group will benefit from musical listening during the induction period of the anesthesia. The control group will have a usual care.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941847
- Sponsor's protocol ID
- CHU 19-007
- Acronym
- MUSINDUC
- Status last verified
- Jan 2020
- First submitted
- 6 May 2019
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musinduc : Impact of Music During the Period of Anaesthetic Induction - a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03941847
- Acronym / sponsor ID
- MUSINDUC / CHU 19-007
- Conditions
- Music, Anesthetic, Induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 8 May 2019 (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.
Anesthetic induction requires the use of, among other things, hypnotic drugs that can lead to hemodynamic disorders, postoperative cognitive dysfunctions and delayed awakening. A strategy to reduce the doses of hypnotics administered could improve patients' postoperative outcomes and is part of the current strategy of accelerated postoperative rehabilitation. Music has shown its effectiveness in reducing the doses of hypnotics administered during sedation procedures.
Objective :
We propose a study of this anesthetic period evaluating the effectiveness of music as an adjuvant agent for anesthetic drugs allowing hypnotic savings.
Materials and methods :
Randomized, prospective, monocentric study
2 groups will be compared. The experimental group will benefit from musical listening during the induction period of the anesthesia. The control group will have a usual care.
The primary endpoint is the amount of hypnotic (propofol®) used during anesthesia induction. The main secondary criteria are the duration of induction, the cost of induction, and the postoperative pain score and the proportion of patients with postoperative nausea and vomiting.
This study should include 104 subjects (52 in each group) requiring general anesthesia.
Hypothesis tested:
Listening to music reduces the amount of hypnotic product used in the induction of anesthesia by 0.5 mg/kg.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups will be compared. The experimental group will benefit from musical listening during the induction period of the anesthesia. The control group will have a usual care.
| Arm | Type | Receives |
|---|---|---|
| music | Experimental | Other: musicThe experimental group will benefit from musical listening during a classic period of induction of anesthesia |
| silence | No intervention | –The control group will have a usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient presenting for surgery under general anesthesia in ophthalmic surgery, ENT, CMF and neurosurgery (lumbar and cervical disc hernia, neurostimulator insertion, vertebral cementoplasty)
- Score ASA 1, 2, 3.
- Intervention time < 3 hours.
Key exclusion criteria (6 listed)
- Patients under 18 years of age
- Patient under guardianship or curatorship
- Refusal of the patient
- Deaf patient
- Non-cooperating patient
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 |
|---|---|---|
| musiclistening music | Other | music |
Primary outcome
quantity of propofol
Time frame: 2 months
quantity of propofol in mg/kg necessary for the induction of general anaesthesia
1 secondary outcome
Quantity of morphinomimetics
Time frame: 2 months
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 24 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Music, Anesthetic, Induction
Active, not recruiting
Effect of Music on Patient Comfort
Perioperative Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music in people with Music, Anesthetic, Induction, run by University Hospital, Caen at 1 site in France.
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 3 inclusion and 6 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 24 Aug 2022. 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 France. 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 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?
quantity of propofol (time frame: 2 months). 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 24 Aug 2022.