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NCT Number: NCT05322902

Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance

The investigators hypothesized that intraoperative opioid consumption would be different between remimazolam and propofol if the ANI-guided remifentanil continuous infusion rate was adjusted when the depth of anesthesia was maintained at similar depths with remimazolam or propofol under total intravenous anesthesia. The purpose of this study is to compare the intraoperative remifentanil requirement in patients undergoing total knee arthroplasty when the intraoperative remifentanil dose adjustment was performed under the ANI guidance while maintaining a similar depth of anesthesia with remimazolam or propofol.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Remimazolam Rheumatic Diseases Total Knee Arthroplasty

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 19~80 years of age who are expected to elective total knee arthroplasty under general anesthesia
  • ASA PS 1-3

Exclusion criteria

  • Second total knee arthroplasty under a prior plan of staged total knee arthroplasty, both
  • Previous hepatectomy or liver transplant
  • Estimated glomerular filtration rate < 30 mL/min/1.73m2
  • Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
  • Uncontrolled hypertension (systolic blood pressure > 160mmHg)
  • Acute narrow angle glaucoma
  • Myasthesia gravis
  • Known allergy to the drugs included in the study
  • Cardiac arrhthmia (non-sinus rhythm)
  • Taking drugs that affect the autonomic nervous system of diabetes
  • Psychiatric or neurologic disease (major depression disorder, dementia or cerebral infarction)
  • History of drug or alcohol abuse

Treatment and study plan

Remimazolam group

Drug

Remimazolam 6 mg/kg/hr is administered as an intravenous infusion until the patient loses consciousness. Anesthesia is maintained at 1 mg/kg/hr of remimazolam. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50.

Propofol group

Drug

Propofol intravenous infusion is initiated by the application of a target concentration infusion (TCI) pump to cause the patient to lose consciousness. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50.

Primary outcomes

  1. Intraoperative remifentanil consumption (mcg/kg/min)

    Time frame: Day 0, intraoperative

    At the start of anesthesia induction, intravenous remifentanil infusion is started and the intraoperative remifentanil infusion rate is adjusted based on the ANI 50 during surgery. The total dose of remifentanil infused intraoperatively is recorded.

Secondary outcomes

  1. Numeric rating scale pain score at rest

    Time frame: up to 24 hours after the surgery

    Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 1, 6, 24 hours after the surgery.

  2. Postoperative opioid consumption

    Time frame: up to 24 hours after the surgery

    Postoperative opioid consumption

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

Comparison of Intraoperative Remifentanil Requirements During Remimazolam Versus Propofol Total Intravenous Anesthesia With Analgesia Nociception Index-guided Remifentanil Administration: a Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2022
Registry last updated
Jul 19, 2023

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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