Sedation of Remazolam Combined With Afentanil in Non-intubated Thoracoscopic Pulmonary Surgery

NCT06810843 | Not Yet Recruiting

• 1 other identifier: YXLL-KY-2024(169)
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

Non-intubated Thoracoscopic surgery (NITS) is a newly emerging minimally invasive surgical technique in recent years . Compared with traditional intubation general anesthesia, it has the advantages of less trauma, faster recovery and fewer complications . This surgical method allows patients to perform under local anesthesia or regional block and moderate sedation, providing a physiologic ventilation method , reducing the intervention on the respiratory system and conducive to rapid postoperative recovery. The importance of sedative drugs in non-intubated thoracoscopic surgery Successful implementation of non-intubated thoracoscopic surgery requires sound regional block, airway management, and rational use of intravenous sedation and analgesics . In addition, sedative drugs need to have less respiratory and circulatory inhibition and fewer side effects. Propofol, as the most commonly used sedative drug, has a high incidence of adverse reactions such as injection pain and respiratory and circulatory inhibition. A large number of meta-analyses and systematic reviews have compared the sedative effects of remazolam and propofol, proving that Remazolam, as a new sedative, has advantages such as short half-life, rapid onset, rapid recovery, and light respiratory and circulatory inhibition.Compared with traditional benzodiazepines, Remazolam has a shorter half-life, which is conducive to rapid postoperative wakeup and reduces the risk of discomfort and cognitive dysfunction in patients. In addition, remazolam has little influence on the respiratory system and is relatively stable on the circulatory system ，which is an ideal sedation option for non-intubated thoracoscopic surgery that retains spontaneous respiration. Afentanil mainly acts on μ opioid receptors , and its analgesic intensity is about 15 times that of morphine, which has the advantages of rapid onset, short duration of action, rapid recovery, high safety, and few adverse reactions . Afentanil has a short half-life , mild respiratory depression, low incidence of cough, postoperative nausea and vomiting . Remazolam combined with afentanil is widely used in various surgeries or examinations that preserve spontaneous breathing, such as gastroenteroscopy, ERCP, hysteroscopy, short-term plastic surgery and fiberbronchoscopy, and has shown the advantage of light respiratory circulation inhibition . We speculate that remazolam combined with afentanil may have certain advantages in non-intubated thoracoscopic surgery that retains spontaneous breathing. At present, the application of remazolam combined with afentanil in non-intubated thoracoscopic surgery is still lacking. The purpose of this study was to observe the safety and effectiveness of remazolam combined with afentanil in non-intubated thoracoscopic surgery, and to provide a better choice of sedation drugs for non-intubated thoracoscopic surgery.

Conditions

Pulmonary Nodule Cm

Keywords

Non-intubated thoracoscopic surgery; Tubleless VATS; Remazolam; alfentanyl; NITS

Outcome Measures

Primary Outcomes (1)

• the incidence of hypoxia

  The primary indicator was the incidence of hypoxia, defined as SpO2 \< 90%,T\>10s.Record whether and how often patients experienced pulse oxygen saturation below 90%.

  during the surgery

Secondary Outcomes (8)

• Frequency of intraoperative hypoxemia

  during the surgery

• the number of minor airway operations required and remedial measures

  during the surgery

• The minimum SpO2 were recorded

  during the surgery

• MAP at different time points

  preinduction（T0） ,1minute （T1）、 3 minutes after induction（T2） ， At the beginning of the operation (T3)， 5 、10、15minutes after the operation began (T4、T5、T6) ，5minutes after withdrawal of anesthesia (T7)

• HR at different time points

  preinduction（T0） ,1minute （T1）、 3 minutes after induction（T2） ， At the beginning of the operation (T3)， 5 、10、15minutes after the operation began (T4、T5、T6) ，5minutes after withdrawal of anesthesia (T7)

Study Arms (2)

Group-R

EXPERIMENTAL

Afentanil (dose 10 μg/kg, Yichang Renfu Pharmaceutical Co., LTD.), 3 minutes before sedative administration. Then, in the remazolam group (group R), 0.3mg/kg remazolam (Yichang Renfu Pharmaceutical Co., LTD.) \> 60 seconds. Sedation was maintained by continuous infusion of remazolam 0.2 to 1 mg/kg/h and afentanil 0 to 1μg/kg/min.

Drug: Remazolam combined with afentanil for non-intubated thoracoscopic surgery

Group-P

ACTIVE COMPARATOR

Propofol group (Group P) was given 1.5 to 2mg/kg propofol, continued infusion of propofol 2 to 6 mg/kg/h and afentanil 0 to 1μg/kg/min to maintain sedation. The anesthesiologist maintained sedation at the target level, maintaining the Modified Observer Alertness/Sedation Scale (MOAA/S) between 1-2.

Drug: Propofol combined with afentanil in non-intubated thoracoscopic surgery

Interventions

Remazolam combined with afentanil for non-intubated thoracoscopic surgery DRUG

Remazolam combined with afentanil for sedation in patients undergoing non-intubated thoracoscopic surgery,

Also known as: Under the guidance of local anesthesia ultrasound, three paravertebral T4-5-6 points were blocked successively

Group-R

Propofol combined with afentanil in non-intubated thoracoscopic surgery DRUG

Propofol combined with afentanil for sedation in patients undergoing non-intubated thoracoscopic surgery,

Also known as: Under the guidance of local anesthesia ultrasound, three paravertebral T4-5-6 points were blocked successively

Group-P

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists ASA Level I to III;
• years-80 years old;
• Non-intubated thoracoscopic lung surgery under deep sedation;
• kg/m2≤BMI≤30 kg/m2;
• Voluntarily participate in the study and sign the informed consent.

You may not qualify if:

• Pulmonary function tests showed moderate to severe ventilation or exchange disorders (FEV1\< 60% of the predicted value, carbon monoxide diffusion \< 60% of the predicted value);
• Abnormal liver and kidney function (Child-Pugh grade liver function is grade B and grade C; Endogenous creatinine clearance ≤50mL/min, serum creatinine \>178µmol/L or urea nitrogen \>9mmol/L by renal function test);
• SpO2 \< 95% before operation;
• History of recovery from abnormal surgical anesthesia;
• History of thoracic surgery or history of tuberculosis or systemic infection within one month;
• Severe cardiovascular and cerebrovascular diseases (patients with severe cardiovascular and cerebrovascular diseases:
• High risk of hypertension, untreated coronary heart disease, valvular heart disease, previous myocardial infarction, cerebral infarction, cerebral thrombus, cerebral hemorrhage);
• Take monoamine oxidase inhibitors or antidepressants within 15 days;
• Chronic pain from long-term use of analgesics or psychotropic drugs, alcoholism;
• Known drug allergy;
• Expected difficult airway;
• Pregnant women or women giving birth;
• Participation in other drug trials within three months or inability to communicate well with researchers

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University（Qianfoshan Hospital, Shandong Province）

Jinan, China

Location

Study Officials

• jian Bo Wu, PH.D

  Shandong First Medical University

  STUDY CHAIR

Central Study Contacts

jian bo Wu, PH.D

CONTACT

18560083793; jianbowu@126.com

NA GUO

CONTACT

18615605135; xinzangbianshu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: February 6, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

CN (1)