DoseED50-MOS-PHNCT06018207
ED50 of Midazolam Oral Solution for Preoperative Hypnosis in Adults : An Up-and-Down Sequential Allocation Trial
A study testing Midazolam oral solution in people with Dose and Midazolam, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Due to sleep deficiency, patients with insomnia syndrome or sub-clinical insomnia syndrome often undergo severe stress while waiting for surgery. Studies have reported that preoperative hypnosis could reduce stress and promote recovery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dose, Midazolam, Preoperative
- What is being tested?
- Midazolam oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2023to 26 Oct 2023
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed of informed consent voluntarily;
- Native Chinese speaker;
- Age 18-60 years old, male or female;
- BMI 18-30 kg/m2;
- American Society of Anesthesiologists (ASA) grade 1 or 2, New York Heart Association (NYHA) gradeⅠorⅡ;
- Non-emergency cancer resection surgery is planned in the next day;
- Insomnia syndrome or sub-clinical insomnia syndrome in the past 1 month.
Who cannot join
- Contraindications for Midazolam Oral Solution (According to the Instruction for Midazolam Oral Solution);
- High risk of Obstructive Sleep Apnea Symptoms (Total score of STOP-Bang scale ≥3 points);
- Suspected dementia (Total score of Mini-Mental State Examination (MMSE) according to years of education: 0 year≤19 points; 1~6 years≤22 points; above of 6 years≤26 points);
- Severe depressive symptom within two weeks (Total score of Patient Health Questionnaire-9 (PHQ-9)≥15);
- History of Neurological and Psychiatric diseases (According to the electronic medical record system);
- History of Chronic Obstructive Pulmonary Disease (According to the electronic medical record system);
Show all 14Show fewer
- History of Heart Failure (According to the electronic medical record system);
- Intestinal obstruction(The electronic medical record system records those who currently have any type of intestinal obstruction);
- Liver and renal insufficiency;
- Have taken opioids or drugs that act on the central nervous system within one week;
- Take CYP3A4 isoenzyme inhibitors or inducers within one week (According to the Instruction for Midazolam Oral Solution);
- Consume any alcoholic beverage within 24 hours;
- Substance abusers (including alcohol, drugs or addictive substances);
- Pregnant or lactating women;
Trial locations and contacts
1 site in 1 country.
China1 site
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
Official title: The Median Effective Dose of Midazolam Oral Solution for Preoperative Hypnosis in Non-Elderly Adults in the Preoperative Room: An Up-and-Down Sequential Allocation Trial
Due to sleep deficiency, patients with insomnia syndrome or sub-clinical insomnia syndrome often undergo severe stress while waiting for surgery. Studies have reported that preoperative hypnosis could reduce stress and promote recovery. Midazolam has been recommended to patients who under severe stress for preoperative sedation and anti-anxiety. However, midazolam for preoperative hypnosis monitored with polysomnography (PSG) has not been studied. In this exploratory study, the median effective dose (ED50) and ED95 of Midazolam Oral Solution for preoperative hypnosis in non-elderly adults using the gold standard tool of PSG, will be explored by up-and-down sequential allocation and probit method.
Read the detailed description
The exploratory study of ED50 will be manipulated by an up-and-down sequential allocation with a single arm prospectively.
- The day before surgery, subjects will be enrolled according to the inclusion criteria and sign the informed consent voluntarily.
- On the day of surgery, the clinical process is as follows. According to the routine medical procedures of our center, patients should access in the operating room about 2 hours before their surgery for adequate preparation.After peripheral venous catheterization, monitored by electrocardiogram, noninvasive blood pressure, and pulse oxygen saturation, invasive procedures,such as arterial catheterization, central venous catheterization or nerve blocks, will be operated individually according to surgical and anesthesia necessity.
- The intervention of Midazolam Oral Solution for preoperative hypnosis will be done after invasive procedures. The ED50 dose of midazolam oral solution for hypnosis is studied using an up-and-down sequential allocation while waiting for surgery and general anesthesia in preoperative room. The starting dose is 6 mg and the step size is 1 mg. The interval sequential dose is varied by 1 mg based on the hypnosis response of the previous patient after one hour. Sleep of the subjects will be monitored by portable PSG (Alice PDx). Definition of successful hypnosis by taking midazolam oral solution: The polysomnograph (PSG) not only shows stage N2 within 30 minutes, but also shows stage N3 within an hour; or else, definition of unsuccessful hypnosis. The intervention procedure : (1) The first subject takes 6mg of midazolam oral solution; (2) If succeed, the second subject will take 5mg; (3) If not succeed, the second subject will take 7mg; (4) Until seven sequence reversal inflection points.
- Measures of safety assurance: (1)Monitoring: Electrocardiogram, blood pressure, pulse oxygen saturation, respiratory rate, consciousness; (2)Monitors, negative pressure suction devices, oxygen inhalation devices, ventilators, items needed for emergency airway establishment, first aid medications, systemically trained anesthesiologists and nurses; (3)Emergencies include, but are not limited to: vomiting, respiratory depression, and respiratory obstruction. If any of the above events occur after intervention, the clinical procedures or emergency procedures will be followed immediately.
Statistics： Using the sequential and probit method to determine the median effective dose and ED95. The sample size is considered adequate once 7 pairs of sequence reversals have been reached. Based on the preliminary test analysis, it is anticipated that 40 subjects would be required.
- Conditions
- Dose, Midazolam, Preoperative
- Being tested
- Midazolam oral solution
- Keywords
- midazolam; sleep; ED50; ED95; preoperative room;adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam oral solutionDrug
The ED50 dose of midazolam oral solution for hypnosis is studied using an up-and-down sequential allocation while waiting for surgery and general anesthesia in preoperative room.
The starting dose is 6 mg and the step size is 1 mg. The interval sequential dose is varied by 1 mg based on the hypnosis response of the previous patient after one hour.
Definition of successful hypnosis by taking midazolam oral solution:
The polysomnograph (PSG) not only shows stage N2 within 30 minutes, but also shows stage N3 within an hour; or else, definition of unsuccessful hypnosis.
The procedure is as follows: (1) The first subject is given 6mg of midazolam oral solution; (2) If succeed, the second subject takes 5mg; (3) If not succeed, the second subject takes 7mg; (4) Until seven sequence reversal inflection points.
| Study group | Role | What they receive |
|---|---|---|
| An Up-and-Down Sequential Allocation | Experimental | An Up-and-Down Sequential Allocation is that the dose is varied based on the hypnosis response of the previous patient after taking midazolam oral solution for 1 hour. Receives: Drug: Midazolam oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Median Effective Dose (ED50) of Midazolam Oral Solution
The Median Effective Dose (ED50) of Midazolam Oral Solution for Preoperative Hypnosis in Non-Elderly Adults in the Preoperative Room, using an up-and-down sequential allocation.
Measured: Within 1 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Secondary outcomes (9)
ED95 of Midazolam Oral Solution for Preoperative Hypnosis in Non-Elderly Adults in the Preoperative Room
ED95 of Midazolam Oral Solution for Preoperative Hypnosis in Non-Elderly Adults in the Preoperative Room, using an up-and-down sequential allocation and calculating by Probit method (probability unit regression).
Measured: Within 1 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of Proportions of stage N1 in different doses
We speculate that the sleep structure is different with the different doses of Midazolam Oral Solution.
Description of Proportions of stage N1 in different doses. Data are expressed as percentages.
Measured: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of Proportions of stage N2 in different doses
We speculate that the sleep structure is different with the different doses of Midazolam Oral Solution.
Description of Proportions of stage N2 in different doses. Data are expressed as percentages.
Measured: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of Proportions of stage N3 in different doses
We speculate that the sleep structure is different with the different doses of Midazolam Oral Solution.
Description of Proportions of stage N3 in different doses. Data are expressed as percentages.
Measured: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of Proportions of stage REM in different doses
We speculate that the sleep structure is different with the different doses of Midazolam Oral Solution.
Description of Proportions of stage REM in different doses. Data are expressed as percentages.
Measured: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of Sleep latency(min) in different doses
Sleep latency(min): the time it takes from taking Midazolam Oral Solution to entering the N2 phase of sleep.
We speculate that sleep latency is different with the doses of Midazolam Oral Sulution.
Data are expressed as mean ± standard deviation.
Measured: Within 1 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of anti-anxiety effects in different doses
Description of the different anti-anxiety effects between those who reach the hypnotic end point and those who do not, using the Generalized Anxiety Disorder-2 (GAD-2) scale.
Data are expressed as mean ± standard deviation.
Measured: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of sedative effect in different doses
Description of the different sedative effects between those who reach the hypnotic end point and those who do not, using Richmond Agitation and Sedation Scale (RASS).
Data are expressed as mean ± standard deviation.
Measured: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of satisfaction for preoperative hypnosis in different doses
Description of sleep satisfaction while waiting for surgery in the operating room after taking Midazolam Oral Solution, using Visual Analogue Scale（VAS）score (0-10 points).
Data are expressed as mean ± standard deviation.
Measured: On postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start5 Sep 2023
- Primary completion25 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DoseStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SanQing Jin, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Jin sanqing, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018207
- Sponsor's protocol ID
- 2023ZSLYEC-402
- Acronym
- ED50-MOS-PH
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Median Effective Dose of Midazolam Oral Solution for Preoperative Hypnosis in Non-Elderly Adults in the Preoperative Room: An Up-and-Down Sequential Allocation Trial
- ClinicalTrials.gov ID
- NCT06018207
- Acronym / sponsor ID
- ED50-MOS-PH / 2023ZSLYEC-402
- Conditions
- Dose, Midazolam, Preoperative
- Keywords
- midazolam; sleep; ED50; ED95; preoperative room;adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 30 Aug 2023 (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.
Due to sleep deficiency, patients with insomnia syndrome or sub-clinical insomnia syndrome often undergo severe stress while waiting for surgery. Studies have reported that preoperative hypnosis could reduce stress and promote recovery. Midazolam has been recommended to patients who under severe stress for preoperative sedation and anti-anxiety. However, midazolam for preoperative hypnosis monitored with polysomnography (PSG) has not been studied. In this exploratory study, the median effective dose (ED50) and ED95 of Midazolam Oral Solution for preoperative hypnosis in non-elderly adults using the gold standard tool of PSG, will be explored by up-and-down sequential allocation and probit method.
Detailed description
The exploratory study of ED50 will be manipulated by an up-and-down sequential allocation with a single arm prospectively.
- The day before surgery, subjects will be enrolled according to the inclusion criteria and sign the informed consent voluntarily.
- On the day of surgery, the clinical process is as follows. According to the routine medical procedures of our center, patients should access in the operating room about 2 hours before their surgery for adequate preparation.After peripheral venous catheterization, monitored by electrocardiogram, noninvasive blood pressure, and pulse oxygen saturation, invasive procedures,such as arterial catheterization, central venous catheterization or nerve blocks, will be operated individually according to surgical and anesthesia necessity.
- The intervention of Midazolam Oral Solution for preoperative hypnosis will be done after invasive procedures. The ED50 dose of midazolam oral solution for hypnosis is studied using an up-and-down sequential allocation while waiting for surgery and general anesthesia in preoperative room. The starting dose is 6 mg and the step size is 1 mg. The interval sequential dose is varied by 1 mg based on the hypnosis response of the previous patient after one hour. Sleep of the subjects will be monitored by portable PSG (Alice PDx). Definition of successful hypnosis by taking midazolam oral solution: The polysomnograph (PSG) not only shows stage N2 within 30 minutes, but also shows stage N3 within an hour; or else, definition of unsuccessful hypnosis. The intervention procedure : (1) The first subject takes 6mg of midazolam oral solution; (2) If succeed, the second subject will take 5mg; (3) If not succeed, the second subject will take 7mg; (4) Until seven sequence reversal inflection points.
- Measures of safety assurance: (1)Monitoring: Electrocardiogram, blood pressure, pulse oxygen saturation, respiratory rate, consciousness; (2)Monitors, negative pressure suction devices, oxygen inhalation devices, ventilators, items needed for emergency airway establishment, first aid medications, systemically trained anesthesiologists and nurses; (3)Emergencies include, but are not limited to: vomiting, respiratory depression, and respiratory obstruction. If any of the above events occur after intervention, the clinical procedures or emergency procedures will be followed immediately.
Statistics： Using the sequential and probit method to determine the median effective dose and ED95. The sample size is considered adequate once 7 pairs of sequence reversals have been reached. Based on the preliminary test analysis, it is anticipated that 40 subjects would be required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| An Up-and-Down Sequential Allocation | Experimental | Drug: Midazolam oral solutionAn Up-and-Down Sequential Allocation is that the dose is varied based on the hypnosis response of the previous patient after taking midazolam oral solution for 1 hour. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed of informed consent voluntarily;
- Native Chinese speaker;
- Age 18-60 years old, male or female;
- BMI 18-30 kg/m2;
- American Society of Anesthesiologists (ASA) grade 1 or 2, New York Heart Association (NYHA) gradeⅠorⅡ;
Key exclusion criteria (14 listed)
- Contraindications for Midazolam Oral Solution (According to the Instruction for Midazolam Oral Solution);
- High risk of Obstructive Sleep Apnea Symptoms (Total score of STOP-Bang scale ≥3 points);
- Suspected dementia (Total score of Mini-Mental State Examination (MMSE) according to years of education: 0 year≤19 points; 1~6 years≤22 points; above of 6 years≤26 points);
- Severe depressive symptom within two weeks (Total score of Patient Health Questionnaire-9 (PHQ-9)≥15);
- History of Neurological and Psychiatric diseases (According to the electronic medical record system);
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 |
|---|---|---|
| Midazolam oral solutionThe ED50 dose of midazolam oral solution for hypnosis is studied using an up-and-down sequential allocation while waiting for surgery and general anesthesia in preoperative room. The starting dose is 6 mg and the step size is 1 mg. The interval sequential dose is varied by 1 mg based on the hypnosis response of the previous patient after one hour. Definition of successful hypnosis by taking midazolam oral solution: The polysomnograph (PSG) not only shows stage N2 within 30 minutes, but also shows stage N3 within an hour; or else, definition of unsuccessful hypnosis. The procedure is as follows: (1) The first subject is given 6mg of midazolam oral solution; (2) If succeed, the second subject takes 5mg; (3) If not succeed, the second subject takes 7mg; (4) Until seven sequence reversal inflection points. | Drug | An Up-and-Down Sequential Allocation |
Primary outcome
The Median Effective Dose (ED50) of Midazolam Oral Solution
Time frame: Within 1 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
The Median Effective Dose (ED50) of Midazolam Oral Solution for Preoperative Hypnosis in Non-Elderly Adults in the Preoperative Room, using an up-and-down sequential allocation.
9 secondary outcomes
ED95 of Midazolam Oral Solution for Preoperative Hypnosis in Non-Elderly Adults in the Preoperative Room
Time frame: Within 1 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of Proportions of stage N1 in different doses
Time frame: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of Proportions of stage N2 in different doses
Time frame: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of Proportions of stage N3 in different doses
Time frame: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of Proportions of stage REM in different doses
Time frame: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of Sleep latency(min) in different doses
Time frame: Within 1 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of anti-anxiety effects in different doses
Time frame: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of sedative effect in different doses
Time frame: Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
Description of satisfaction for preoperative hypnosis in different doses
Time frame: On postoperative day 1
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 6 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Jin sanqing, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam oral solution in people with Dose and Midazolam, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 7 inclusion and 14 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 6 Aug 2025. 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 China. 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?
The Median Effective Dose (ED50) of Midazolam Oral Solution (time frame: Within 1 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room). 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 6 Aug 2025.