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

General Anesthetic Drug Adverse Reaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05468671
• Other study ID #: IRB-2020-406
• Status: Completed
• Phase: Phase 4
• Start date: January 4, 2021
• Est. completion date: September 8, 2022

Study information

• Verified date: October 2022
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 8, 2022
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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 ? and above
• Emergency Surgery

Related Conditions & MeSH terms

• Bronchoesophageal Fistula
• Drug-Related Side Effects and Adverse Reactions
• Endobronchial Metastases
• Fistula
• General Anesthetic Drug Adverse Reaction

Intervention

Drug:
• Remimazolam
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.
• Propofol
Propofol is used to put you to sleep and keep you asleep during general anesthesia for surgery or other medical procedures.
• Rocuronium
Rocuronium is a non-depolarizing neuromuscular blocker
• Remifentanil
Remifentanil is an esterase-metabolized opioid
• oxycodone
Oxycodone is an opiate painkiller.
• Sugammadex Sodium
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
• Flumazenil
Flumazenil is used to reverse the effects of a benzodiazepine

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hanzhou

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	postoperative, 2 hours
Secondary	Modified Brice Questionnaire in YES or NO	Modified Brice interview over quality assurance techniques in detecting intraoperative awareness.	postoperative,24 hours
Secondary	Intraoperative mean arterial blood pressure in mmHg	Fluctuations in intraoperative systolic, diastolic pressures and mean arterial pressure will be recorded	Intraoperative,4hours
Secondary	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.	Baseline, 1 year
Secondary	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.	Induction of anesthesia,10 minutes
Secondary	The incidence of Postoperative delirium in rate	The proportion of cases of postoperative delirium in the enrolled patients	postoperative,24 hours
Secondary	Intraoperative heart rate in beats per minute	Fluctuations in intraoperative heart rate will be recorded	Intraoperative,4hours
Secondary	The incidence of postoperative vomiting in rate	The proportion of cases of postoperative vomiting in the enrolled patients	postoperative,24 hours