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Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy

Primary Purpose

Endobronchial Metastases, Bronchoesophageal Fistula, General Anesthetic Drug Adverse Reaction

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Remimazolam
Propofol
Rocuronium
Remifentanil
oxycodone
Sugammadex Sodium
Flumazenil
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endobronchial Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing bronchoscopy endotracheal tumor resection or stenting of acquired tracheoesophageal fistula within a limited time
  • >18 Years
  • ASA Ⅱ-Ⅳ

Exclusion Criteria:

  • <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

Sites / Locations

  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remazolam general anesthesia group (R group)

Propofol general anesthesia control group (P group)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Modified Brice Questionnaire in YES or NO
Modified Brice interview over quality assurance techniques in detecting intraoperative awareness.
Intraoperative mean arterial blood pressure in mmHg
Fluctuations in intraoperative systolic, diastolic pressures and mean arterial pressure will be recorded
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.
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.
The incidence of Postoperative delirium in rate
The proportion of cases of postoperative delirium in the enrolled patients
Intraoperative heart rate in beats per minute
Fluctuations in intraoperative heart rate will be recorded
The incidence of postoperative vomiting in rate
The proportion of cases of postoperative vomiting in the enrolled patients

Full Information

First Posted
July 13, 2022
Last Updated
October 24, 2022
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05468671
Brief Title
Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
August 4, 2021 (Actual)
Study Completion Date
September 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endobronchial Metastases, Bronchoesophageal Fistula, General Anesthetic Drug Adverse Reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remazolam general anesthesia group (R group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Propofol general anesthesia control group (P group)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Remimazolam
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol is used to put you to sleep and keep you asleep during general anesthesia for surgery or other medical procedures.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
Rocuronium is a non-depolarizing neuromuscular blocker
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Remifentanil is an esterase-metabolized opioid
Intervention Type
Drug
Intervention Name(s)
oxycodone
Intervention Description
Oxycodone is an opiate painkiller.
Intervention Type
Drug
Intervention Name(s)
Sugammadex Sodium
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Flumazenil
Intervention Description
Flumazenil is used to reverse the effects of a benzodiazepine
Primary Outcome Measure Information:
Title
Recovery time in seconds
Description
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
Time Frame
postoperative, 2 hours
Secondary Outcome Measure Information:
Title
Modified Brice Questionnaire in YES or NO
Description
Modified Brice interview over quality assurance techniques in detecting intraoperative awareness.
Time Frame
postoperative,24 hours
Title
Intraoperative mean arterial blood pressure in mmHg
Description
Fluctuations in intraoperative systolic, diastolic pressures and mean arterial pressure will be recorded
Time Frame
Intraoperative,4hours
Title
Perioperative Nutrition Status Assessment Scale (PONS) in YES or NO
Description
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.
Time Frame
Baseline, 1 year
Title
Onset time in seconds
Description
The time from the start of peripheral intravenous injection of general anesthetic to the patient's loss of consciousness. Time is measured in seconds.
Time Frame
Induction of anesthesia,10 minutes
Title
The incidence of Postoperative delirium in rate
Description
The proportion of cases of postoperative delirium in the enrolled patients
Time Frame
postoperative,24 hours
Title
Intraoperative heart rate in beats per minute
Description
Fluctuations in intraoperative heart rate will be recorded
Time Frame
Intraoperative,4hours
Title
The incidence of postoperative vomiting in rate
Description
The proportion of cases of postoperative vomiting in the enrolled patients
Time Frame
postoperative,24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing bronchoscopy endotracheal tumor resection or stenting of acquired tracheoesophageal fistula within a limited time >18 Years ASA Ⅱ-Ⅳ Exclusion Criteria: <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
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hanzhou
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy

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