Midazolam versus Propofol for Moderate Sedation: Effects on Sedation Recovery Time in Healthy Volunteers – A Single-Center, Single-Blind, Randomized Crossover Trial Using fMRI-EEG

??Effects of Midazolam versus Propofol-induced Moderate Sedation on Recovery Time in Healthy Volunteers: A Single-center, Single-blind, Randomized Crossover Controlled Trial Using fMRI-EEG? - Effect of Midazolam versus Propofol on Sedation Recovery Time: An fMRI-EEG Randomized Crossover Trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500113969

Enrollment

Unknown

Registered

2025-12-04

Start date

2025-12-20

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedures such as GI endoscopy and MRI performed in outpatient settings?

Interventions

the midazolam group :Midazolam group: Baseline awake period (T0): Received a single intravenous injection of 2 mL normal saline as a placebo control. Moderate sedation period (T1): Received a single i

the propofol group:Baseline awake period (T0): Received a single intravenous injection of 2 mL normal saline as a placebo control. Moderate sedation period (T1): Administered propofol via target-contr

Eligibility

Sex/Gender

All

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Healthy individuals who underwent a health check-up at this hospital within the last 3 months, with no significant underlying diseases (e.g., cardiovascular, hepatic, renal, or central nervous system disorders) confirmed by the check-up (including basic items such as complete blood count, liver and kidney function tests, electrocardiogram, and chest X-ray); 2. Aged 18–35 years, regardless of gender; 3. BMI (Body Mass Index) between 18–27 kg·m^2; 4. ASA (American Society of Anesthesiologists) physical status classification of I-II; 5. Right-handed, with Mandarin Chinese as their native language; 6. No history of major physical or mental illnesses; 7. No contraindications for MRI (e.g., no metal implants, no claustrophobia).

Exclusion criteria

Exclusion criteria: 1. History of head trauma, epilepsy, or impaired consciousness; 2. Long-term medication use, or dependence on drugs or alcohol; 3. Pregnancy, lactation, or planning pregnancy within the next six months; 4. Abnormal liver or kidney function, asthma, or airway hyperresponsiveness; 5. Contraindications to arterial puncture or coagulopathy.

Design outcomes

Primary

Measure	Time frame
Sedation Recovery Time;	—

Secondary

Measure	Time frame
Changes in functional connectivity strength of brain networks (e.g., the default mode network and executive control network) under moderate sedation.?;	—

Countries

China

Contacts

Public ContactHong fei Zhang

Zhujiang Hospital, Southern Medical University

zhanghongfei@smu.edu.cn+86 20 6278 7271

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026