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The Role of Remazolam in Reducing the Incidence of Postoperative Delirium in Elderly Patients

Primary Purpose

Postoperative Delirium

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remazolam
Propofol
Midazolam
Sponsored by
Fang Jun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium

Eligibility Criteria

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

Inclusion Criteria:

  • Elderly patients with limited abdominal tumor surgery (age ≥65 years)
  • ASA classification I-III.

Exclusion Criteria:

  • Refusing to participate in the study
  • Patients with severe arrhythmia or cardiac dysfunction (EF<35%)
  • A clear history of neurological and psychiatric disorders before surgery or long-term use of sedatives or antidepressants
  • History of alcoholism or drug dependence
  • History of brain surgery or trauma
  • Severe vision or hearing impairment
  • Inability to cooperate with the completion of cognitive function tests

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remazolam general anesthesia group (R group)

Propofol + midazolam general anesthesia control group (group P)

Arm Description

Outcomes

Primary Outcome Measures

Incidence of postoperative delirium
Proportion of patients with postoperative delirium among enrolled patients. The incidence of delirium during recovery was assessed by the Confusion Assessment Method-ICU (CAM-ICU). The assessment time points were: 10 minutes, 30 minutes after entering the anesthesia recovery room (or exiting the recovery room). The incidence of delirium within 7 days after surgery was assessed using 3D-CAM to assess whether patients had delirium.

Secondary Outcome Measures

Intraoperative awareness rate
The modified Brice interview over quality assurance techniques in detecting intraoperative awareness with explicit recall.
Intraoperative hemodynamic stability
The change curve of intraoperative mean arterial blood pressure and heart rate
Richard-campbell Sleep Questionnaire Score
Richards-Campbell Sleep Questionnaire (RCSQ) is a five-item、 visual analogue scale was designed for assessing sleep quality of patients
Perioperative nutritional status score table(PONS)
Perioperative Nutrition Screen (PONS). This algorithmic approach is used to identify perioperative malnutrition risk and guide perioperative nutrition intervention. BMI, body mass index
Modified frailty rating scale
Modified Frailty Index Frailty index is an important predictive variable in emergency general surgery patients older than 60 years. The modified frailty index can be used to evaluate risk of both morbidity and mortality in these patients.
Postoperative hospital stay
Taking the operation day as the starting point, calculating the length of stay in the hospital after the operation
Postoperative nausea and vomiting
The proportion of patients with nausea and vomiting within 7 days after surgery

Full Information

First Posted
July 13, 2022
Last Updated
July 13, 2023
Sponsor
Fang Jun
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1. Study Identification

Unique Protocol Identification Number
NCT05466279
Brief Title
The Role of Remazolam in Reducing the Incidence of Postoperative Delirium in Elderly Patients
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
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fang Jun

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a prospective, randomized, controlled trial.The selected patients were randomly divided into remazolam general anesthesia group and propofol + midazolam general anesthesia control group according to computer randomization method. There were 65 patients in each group. Remazolam general anesthesia group (R group): Remazolam 0.4 mg/kg for rapid induction of loss of consciousness for anesthesia induction and 1 mg/kg/h for maintenance. Propofol + midazolam general anesthesia control group (group P): propofol 1.5 mg/kg + midazolam 0.05 mg/kg slow intravenous push until the patient's consciousness disappeared, then propofol 4-8 mg/kg/h Anesthesia was maintained. Except for different sedative drugs, the analgesic and muscle relaxant medication regimens were the same between the two groups. In the study, the application of inhaled anesthetics, other benzodiazepines and anticholinergic drugs was restricted, and the mean arterial pressure during the operation was kept above 60 mmHg to avoid perioperative hypotension, hypoxemia, and hypercapnia. Warm measures were used to maintain the patient's intraoperative body temperature above 36.0 °C. POD assessment was performed on the day before surgery and on days 1-7 after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remazolam general anesthesia group (R group)
Arm Type
Experimental
Arm Title
Propofol + midazolam general anesthesia control group (group P)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
remazolam
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol (2,6-diisopropylphenol) is a hypnotic agent that is used as an induction agent and as a maintenance anaesthetic delivered by continuous i.v. infusion or intermittent i.v. bolus
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Midazolam, like diazepam, is a benzodiazepine anxiolytic drug, which is used to treat anxiety, but its t ½ is much shorter or only about 2 h compared with 43 h for diazepam
Primary Outcome Measure Information:
Title
Incidence of postoperative delirium
Description
Proportion of patients with postoperative delirium among enrolled patients. The incidence of delirium during recovery was assessed by the Confusion Assessment Method-ICU (CAM-ICU). The assessment time points were: 10 minutes, 30 minutes after entering the anesthesia recovery room (or exiting the recovery room). The incidence of delirium within 7 days after surgery was assessed using 3D-CAM to assess whether patients had delirium.
Time Frame
Postoperative, 7 days
Secondary Outcome Measure Information:
Title
Intraoperative awareness rate
Description
The modified Brice interview over quality assurance techniques in detecting intraoperative awareness with explicit recall.
Time Frame
Postoperative, 24 hours
Title
Intraoperative hemodynamic stability
Description
The change curve of intraoperative mean arterial blood pressure and heart rate
Time Frame
Intraoperative, 6 hours
Title
Richard-campbell Sleep Questionnaire Score
Description
Richards-Campbell Sleep Questionnaire (RCSQ) is a five-item、 visual analogue scale was designed for assessing sleep quality of patients
Time Frame
Postoperative, 3 days
Title
Perioperative nutritional status score table(PONS)
Description
Perioperative Nutrition Screen (PONS). This algorithmic approach is used to identify perioperative malnutrition risk and guide perioperative nutrition intervention. BMI, body mass index
Time Frame
Baseline, 1 year
Title
Modified frailty rating scale
Description
Modified Frailty Index Frailty index is an important predictive variable in emergency general surgery patients older than 60 years. The modified frailty index can be used to evaluate risk of both morbidity and mortality in these patients.
Time Frame
Baseline, 1 year
Title
Postoperative hospital stay
Description
Taking the operation day as the starting point, calculating the length of stay in the hospital after the operation
Time Frame
Postoperative, 3 months
Title
Postoperative nausea and vomiting
Description
The proportion of patients with nausea and vomiting within 7 days after surgery
Time Frame
Postoperative, 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elderly patients with limited abdominal tumor surgery (age ≥65 years) ASA classification I-III. Exclusion Criteria: Refusing to participate in the study Patients with severe arrhythmia or cardiac dysfunction (EF<35%) A clear history of neurological and psychiatric disorders before surgery or long-term use of sedatives or antidepressants History of alcoholism or drug dependence History of brain surgery or trauma Severe vision or hearing impairment Inability to cooperate with the completion of cognitive function tests
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hanzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Fang
Phone
008613606617457
Email
fangjun477@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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The Role of Remazolam in Reducing the Incidence of Postoperative Delirium in Elderly Patients

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