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Remimazolam Combined with Propofol for Intraoperative Wake-up Testing in Scoliosis Correction Surgery: A Prospective, Blind, Randomized Controlled Trial

Observations on the Effect of Remimazolam Besylate Combined with Propofol for Intraoperative Wake-up Testing in Patients Undergoing Scoliosis Correction Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076802
Enrollment
Unknown
Registered
2023-10-18
Start date
2023-10-26
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Scoliosis

Interventions

Remimazolam group (group R):The selection of sedative drugs is: Remimazolam+Propofol
Dexmedetomidine group (Group D) :The selection of sedative drugs is: Dexmedetomidine+Propofol
Propofol group (group P):The selection of sedative drugs is: Propofol

Sponsors

The First People's Hospital of Yunnan Province (The Affiliated Hospital of Kunming University of Science and Technology)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Participants scheduled for elective SOSCS; 2. American Society of Anesthesiologists (ASA) physical status I–III; 3. Age 10–50 years; 4. Ability and willingness to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of organic central nervous system disorders or impaired consciousness; 2. Severe coagulopathy; 3. Severe comorbidities, such as severe pulmonary hypertension, hepatic encephalopathy, acute myocardial infarction, acute heart failure, or hepatorenal failure; 4. Psychiatric disorders or communication barriers precluding cooperation during wake-up testing; 5. Participnats on concomitant medications with known interaction potential that may increase adverse reactions; known allergy to any study medication; 6. History of substance abuse or opioid tolerance; 7. Conditions including epilepsy, cortical lesions, cranial defects, intracranial hypertension, or presence of intracranial hardware; 9. Any condition deemed unsuitable for study participation by the investigators.

Design outcomes

Primary

MeasureTime frame
The wake-up time;The wake-up quality;

Secondary

MeasureTime frame
Neuroelectrophysiological monitoring indicators;Cerebral State Index;Hemodynamic monitoring (HR+MAP);Satisfaction;

Countries

China

Contacts

Public ContactJin Hua

The First People's Hospital of Yunnan Province (The Affiliated Hospital of Kunming University of Science and Technology)

jinhuakm@163.com+86 138 8866 8869

Outcome results

None listed

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