Status:
COMPLETED
ED50 of Midazolam Oral Solution for Preoperative Hypnosis in Adults : An Up-and-Down Sequential Allocation Trial
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Dose
Midazolam
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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...
Detailed Description
The exploratory study of ED50 will be manipulated by an up-and-down sequential allocation with a single arm prospectively. 1. The day before surgery, subjects will be enrolled according to the inclus...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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);
- 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;
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06018207
Start Date
September 5 2023
End Date
October 26 2023
Last Update
August 6 2025
Active Locations (1)
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1
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655