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Completed

NCT Number: NCT05468671

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhejiang Cancer Hospital

Hanzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam

Drug

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

Drug

Propofol is used to put you to sleep and keep you asleep during general anesthesia for surgery or other medical procedures.

Rocuronium

Drug

Rocuronium is a non-depolarizing neuromuscular blocker

Remifentanil

Drug

Remifentanil is an esterase-metabolized opioid

Oxycodone

Drug

Oxycodone is an opiate painkiller.

Sugammadex Sodium

Drug

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

Drug

Flumazenil is used to reverse the effects of a benzodiazepine

Primary outcomes

  1. 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

Secondary outcomes

  1. Modified Brice Questionnaire in YES or NO

    Time frame: postoperative,24 hours

    Modified Brice interview over quality assurance techniques in detecting intraoperative awareness.

  2. Intraoperative mean arterial blood pressure in mmHg

    Time frame: Intraoperative,4hours

    Fluctuations in intraoperative systolic, diastolic pressures and mean arterial pressure will be recorded

  3. Perioperative Nutrition Status Assessment Scale (PONS) in YES or NO

    Time frame: Baseline, 1 year

    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.

  4. Onset time in seconds

    Time frame: Induction of anesthesia,10 minutes

    The time from the start of peripheral intravenous injection of general anesthetic to the patient's loss of consciousness. Time is measured in seconds.

  5. The incidence of Postoperative delirium in rate

    Time frame: postoperative,24 hours

    The proportion of cases of postoperative delirium in the enrolled patients

  6. Intraoperative heart rate in beats per minute

    Time frame: Intraoperative,4hours

    Fluctuations in intraoperative heart rate will be recorded

  7. The incidence of postoperative vomiting in rate

    Time frame: postoperative,24 hours

    The proportion of cases of postoperative vomiting in the enrolled patients

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 21, 2022
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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