Endobronchial MetastasesPhase 4NCT05468671
Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy
A Phase 4 study testing Remimazolam, Propofol and Rocuronium in people with Endobronchial Metastases and Bronchoesophageal Fistula, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study is a prospective, randomized, controlled trial. In this study, 30 patients who underwent endotracheal tumor resection under rigid bronchoscope or stent placement for acquired tracheoesophageal fistula were selected as the subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endobronchial Metastases, Bronchoesophageal Fistula, General Anesthetic Drug Adverse Reaction
- What is being tested?
- Remimazolam, Propofol and Rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2021to 8 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing bronchoscopy endotracheal tumor resection or stenting of acquired tracheoesophageal fistula within a limited time
- >18 Years
- ASA Ⅱ-Ⅳ
Who cannot join
- <18Years
- Refuse to participate
- A history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis;
- Severe hepatic dysfunction (Child-Pugh class C)
- Severe renal dysfunction (requiring dialysis)
- Patients with ASA grade Ⅴ and above
- Emergency Surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Anesthesiology, Cancer Hospital of the University of Chinese Academy of Sciences（Zhejiang Cancer Hospital), Research Center for Neuro-Oncology Interaction , Institute of Basic Medicine and Cancer, Chinese Academy of Sciences
This study is a prospective, randomized, controlled trial. In this study, 30 patients who underwent endotracheal tumor resection under rigid bronchoscope or stent placement for acquired tracheoesophageal fistula were selected as the subjects. The patients were randomly divided into remazolam general anesthesia group (R group) and propofol general anesthesia control group (P group). Remazolam general anesthesia group (R group): Remazolam 0.4 mg/kg, oxycodone 0.2 mg/kg and rocuronium 0.9 mg/kg were given for anesthesia induction. Propofol general anesthesia control group (P group): Propofol 1.5mg/kg, oxycodone 0.2mg/kg and rocuronium 0.9mg/kg were given for induction of anesthesia. After induction, high-frequency jet ventilation was used in both groups, the respiratory rate was 30-60 times/min, the inspiratory-to-breath ratio was 1:2, and the driving pressure was 0.8-1.0 KPa. Group R was given remazolam 1mg/kg/h and remifentanil 6-8ug/kg/h for maintenance. Group P was given propofol 4-8 mg/kg/h and remifentanil 6-8ug/kg/h for anesthesia maintenance. The dosage of propofol or remazolam was adjusted according to BIS and intraoperative hemodynamic changes. Rocuronium bromide 10 mg was added every half hour. Intraoperative application of vasoactive drugs to maintain mean arterial pressure above 60mmHg to avoid perioperative hypotension. Blood oxygen saturation and end-tidal carbon dioxide were monitored to avoid perioperative hypoxemia and hypercapnia, and warm measures were used to maintain the patient's intraoperative body temperature above 36.0°C. After surgery, group R was treated with sugammadex sodium 2-4 mg/kg to antagonize rocuronium bromide, and 0.5 mg of flumazenil was used to antagonize remazolam by intravenous injection; group P was treated with sugammadex 2-4 mg/kg to antagonize rocuronium.
- Conditions
- Endobronchial Metastases, Bronchoesophageal Fistula, General Anesthetic Drug Adverse Reaction
- Being tested
- Remimazolam, Propofol, Rocuronium, Remifentanil, oxycodone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Remimazolam is a new drug innovation in anesthesia. It combines the properties of two unique drugs already established in anesthesia - Midazolam and remifentanil. It acts on GABA receptors like midazolam and has organ-independent metabolism like remifentanil.
PropofolDrug
Propofol is used to put you to sleep and keep you asleep during general anesthesia for surgery or other medical procedures.
RocuroniumDrug
Rocuronium is a non-depolarizing neuromuscular blocker
RemifentanilDrug
Remifentanil is an esterase-metabolized opioid
oxycodoneDrug
Oxycodone is an opiate painkiller.
Sugammadex SodiumDrug
Sugammadex sodium is an organic sodium salt that is the octasodium salt of sugammadex. Used for reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery
FlumazenilDrug
Flumazenil is used to reverse the effects of a benzodiazepine
| Study group | Role | What they receive |
|---|---|---|
| Remazolam general anesthesia group (R group) | Experimental | Remazolam 0.4 mg/kg, oxycodone 0.2 mg/kg and rocuronium 0.9 mg/kg were given for anesthesia induction.Group R was given remazolam 1mg/kg/h and remifentanil 6-8ug/kg/h for maintenance. Receives: Drug: Remimazolam; Drug: Rocuronium; Drug: Remifentanil; Drug: oxycodone; Drug: Sugammadex Sodium; Drug: Flumazenil |
| Propofol general anesthesia control group (P group) | Active comparator | Propofol 1.5mg/kg, oxycodone 0.2mg/kg and rocuronium 0.9mg/kg were given for induction of anesthesia.Group P was given propofol 4-8 mg/kg/h and remifentanil 6-8ug/kg/h for anesthesia maintenance. Receives: Drug: Propofol; Drug: Rocuronium; Drug: Remifentanil; Drug: oxycodone; Drug: Sugammadex Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time in seconds
Taking the stop of general anesthesia as the starting point for timing, the time for the patient to correctly complete the three commands of nodding, mouth opening and tongue extension is recorded, with seconds as the timing unit
Measured: postoperative, 2 hours
Secondary outcomes (7)
Modified Brice Questionnaire in YES or NO
Modified Brice interview over quality assurance techniques in detecting intraoperative awareness.
Measured: postoperative，24 hours
Intraoperative mean arterial blood pressure in mmHg
Fluctuations in intraoperative systolic, diastolic pressures and mean arterial pressure will be recorded
Measured: Intraoperative，4hours
Perioperative Nutrition Status Assessment Scale (PONS) in YES or NO
PONS is a modified version of the malnutrition universal screening tool and determines the presence of nutrition risk based on BMI, recent body weight loss, decrement of dietary intake, and preoperative albumin concentration.
Measured: Baseline, 1 year
Onset time in seconds
The time from the start of peripheral intravenous injection of general anesthetic to the patient's loss of consciousness. Time is measured in seconds.
Measured: Induction of anesthesia，10 minutes
The incidence of Postoperative delirium in rate
The proportion of cases of postoperative delirium in the enrolled patients
Measured: postoperative，24 hours
Intraoperative heart rate in beats per minute
Fluctuations in intraoperative heart rate will be recorded
Measured: Intraoperative，4hours
The incidence of postoperative vomiting in rate
The proportion of cases of postoperative vomiting in the enrolled patients
Measured: postoperative，24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start4 Jan 2021
- Primary completion4 Aug 2021
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endobronchial MetastasesStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Kangjie, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468671
- Sponsor's protocol ID
- IRB-2020-406
- Status last verified
- Oct 2022
- First submitted
- 13 Jul 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Anesthesiology, Cancer Hospital of the University of Chinese Academy of Sciences（Zhejiang Cancer Hospital), Research Center for Neuro-Oncology Interaction , Institute of Basic Medicine and Cancer, Chinese Academy of Sciences
- ClinicalTrials.gov ID
- NCT05468671
- Acronym / sponsor ID
- IRB-2020-406
- Conditions
- Endobronchial Metastases, Bronchoesophageal Fistula, General Anesthetic Drug Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, randomized, controlled trial. In this study, 30 patients who underwent endotracheal tumor resection under rigid bronchoscope or stent placement for acquired tracheoesophageal fistula were selected as the subjects. The patients were randomly divided into remazolam general anesthesia group (R group) and propofol general anesthesia control group (P group). Remazolam general anesthesia group (R group): Remazolam 0.4 mg/kg, oxycodone 0.2 mg/kg and rocuronium 0.9 mg/kg were given for anesthesia induction. Propofol general anesthesia control group (P group): Propofol 1.5mg/kg, oxycodone 0.2mg/kg and rocuronium 0.9mg/kg were given for induction of anesthesia. After induction, high-frequency jet ventilation was used in both groups, the respiratory rate was 30-60 times/min, the inspiratory-to-breath ratio was 1:2, and the driving pressure was 0.8-1.0 KPa. Group R was given remazolam 1mg/kg/h and remifentanil 6-8ug/kg/h for maintenance. Group P was given propofol 4-8 mg/kg/h and remifentanil 6-8ug/kg/h for anesthesia maintenance. The dosage of propofol or remazolam was adjusted according to BIS and intraoperative hemodynamic changes. Rocuronium bromide 10 mg was added every half hour. Intraoperative application of vasoactive drugs to maintain mean arterial pressure above 60mmHg to avoid perioperative hypotension. Blood oxygen saturation and end-tidal carbon dioxide were monitored to avoid perioperative hypoxemia and hypercapnia, and warm measures were used to maintain the patient's intraoperative body temperature above 36.0°C. After surgery, group R was treated with sugammadex sodium 2-4 mg/kg to antagonize rocuronium bromide, and 0.5 mg of flumazenil was used to antagonize remazolam by intravenous injection; group P was treated with sugammadex 2-4 mg/kg to antagonize rocuronium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remazolam general anesthesia group (R group) | Experimental | Drug: Remimazolam, Drug: Rocuronium, Drug: Remifentanil, Drug: oxycodone, Drug: Sugammadex Sodium, Drug: FlumazenilRemazolam 0.4 mg/kg, oxycodone 0.2 mg/kg and rocuronium 0.9 mg/kg were given for anesthesia induction.Group R was given remazolam 1mg/kg/h and remifentanil 6-8ug/kg/h for maintenance. |
| Propofol general anesthesia control group (P group) | Active comparator | Drug: Propofol, Drug: Rocuronium, Drug: Remifentanil, Drug: oxycodone, Drug: Sugammadex SodiumPropofol 1.5mg/kg, oxycodone 0.2mg/kg and rocuronium 0.9mg/kg were given for induction of anesthesia.Group P was given propofol 4-8 mg/kg/h and remifentanil 6-8ug/kg/h for anesthesia maintenance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing bronchoscopy endotracheal tumor resection or stenting of acquired tracheoesophageal fistula within a limited time
- >18 Years
- ASA Ⅱ-Ⅳ
Key exclusion criteria (7 listed)
- <18Years
- Refuse to participate
- A history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis;
- Severe hepatic dysfunction (Child-Pugh class C)
- Severe renal dysfunction (requiring dialysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamRemimazolam is a new drug innovation in anesthesia. It combines the properties of two unique drugs already established in anesthesia - Midazolam and remifentanil. It acts on GABA receptors like midazolam and has organ-independent metabolism like remifentanil. | Drug | Remazolam general anesthesia group (R group) |
| PropofolPropofol is used to put you to sleep and keep you asleep during general anesthesia for surgery or other medical procedures. | Drug | Propofol general anesthesia control group (P group) |
| RocuroniumRocuronium is a non-depolarizing neuromuscular blocker | Drug | Propofol general anesthesia control group (P group), Remazolam general anesthesia group (R group) |
| RemifentanilRemifentanil is an esterase-metabolized opioid | Drug | Propofol general anesthesia control group (P group), Remazolam general anesthesia group (R group) |
| oxycodoneOxycodone is an opiate painkiller. | Drug | Propofol general anesthesia control group (P group), Remazolam general anesthesia group (R group) |
| Sugammadex SodiumSugammadex sodium is an organic sodium salt that is the octasodium salt of sugammadex. Used for reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery | Drug | Propofol general anesthesia control group (P group), Remazolam general anesthesia group (R group) |
| FlumazenilFlumazenil is used to reverse the effects of a benzodiazepine | Drug | Remazolam general anesthesia group (R group) |
Primary outcome
Recovery time in seconds
Time frame: postoperative, 2 hours
Taking the stop of general anesthesia as the starting point for timing, the time for the patient to correctly complete the three commands of nodding, mouth opening and tongue extension is recorded, with seconds as the timing unit
7 secondary outcomes
Modified Brice Questionnaire in YES or NO
Time frame: postoperative，24 hours
Intraoperative mean arterial blood pressure in mmHg
Time frame: Intraoperative，4hours
Perioperative Nutrition Status Assessment Scale (PONS) in YES or NO
Time frame: Baseline, 1 year
Onset time in seconds
Time frame: Induction of anesthesia，10 minutes
The incidence of Postoperative delirium in rate
Time frame: postoperative，24 hours
Intraoperative heart rate in beats per minute
Time frame: Intraoperative，4hours
The incidence of postoperative vomiting in rate
Time frame: postoperative，24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Endobronchial Metastases
Recruiting
Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves
COPD
Not yet recruiting
Evaluation of Endobronchial Ultrasound Needle Cleaning Techniques and Their Impact on Specimen Contamination
Lung Cancer (Locally Advanced or Metastatic)
RecruitingPhase 2
Phase II Trial of Lung Chemoemobolization
Lung Non-Small Cell Carcinoma, Mediastinal Neoplasm
Active, not recruiting
Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC
Lung Cancer, Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam, Propofol and Rocuronium in people with Endobronchial Metastases and Bronchoesophageal Fistula, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time in seconds (time frame: postoperative, 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.