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Effect of Remimazolam Besylate versus Propofol on Haemodynamic Profiles in Patients Undergoing Thyroid Surgery with Recurrent Laryngeal Nerve Monitoring

Effect of Remimazolam Besylate versus Propofol on Haemodynamic Profiles in Patients Undergoing Thyroid Surgery with Recurrent Laryngeal Nerve Monitoring

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076583
Enrollment
Unknown
Registered
2023-10-12
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Thyroid nodule

Interventions

remimazolam:remimazolam 1~3mg/kg/h
Propofol:Propofol TCI 2~4ug/ml

Sponsors

Guangzhou Institute of Cancer Research, the Affiliated Cancer Hospital, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18- 65 years, American Society of Anaesthesiologists (ASA) physical status classification I-III. 2. Patients undergoing thyroid surgery require IONM. 3. Expected duration of surgery to be 4 hours or less. 4. Body mass index (BMI) >= 18 kg/m2 and <= 30 kg/m2. 5. Participation in the study is voluntary and requires signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Participated in other clinical trials within the past 3 months. 2.Patients undergoing other surgery at the same time, emergency surgery, and subsequent admission to intensive care for post-operative care. 3.Patients with suspected allergy to remimazolam, propofol or any of the drugs used in this study (e.g. sufentanil, rocuronium, remifentanil, ciprofol, etc.). 4.Severe systemic cardiovascular disease, such as congestive heart failure, frequent premature ventricular contractions, uncontrolled hypertension/hypotension, etc. 5.Severe respiratory disease. 6.History of dementia, mental illness, or other central nervous system disorders, and current use of sedatives, or antidepressants. 7.End-stage liver failure or kidney disease requiring dialysis. 8.Researcher does not believe it is appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
the occurrence of hypotension, defined as MAP= 30% below preoperative baseline, from induction of anesthesia to full recovery.;

Secondary

MeasureTime frame
the administration of vasoactive agents; the number of hypotension or hypertension episodes requiring intervention;the cumulative duration of hypotension or hypertension;the dose of intraoperative rescue sedation and analgesia;the duration of extubation and awakening;the incidence of adverse events;

Countries

China

Contacts

Public ContactYao Yonghua

Guangzhou Institute of Cancer Research, the Affiliated Cancer Hospital, Guangzhou Medical University

726832646@qq.com+86 137 1156 8864

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026