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Effect of an automated muti-closed-loop anesthesia drug delivery system for total intravenous anesthesia with propofol and remifentanil on intraoperative target blood pressure maintenance in patients with knee arthroscopy: a muti-center, randomized controlled study

Effect of an automated muti-closed-loop anesthesia drug delivery system for total intravenous anesthesia with propofol and remifentanil on intraoperative target blood pressure maintenance in patients with knee arthroscopy: a muti-center, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083585
Enrollment
Unknown
Registered
2024-04-29
Start date
2024-04-30
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of total intravenous anesthesia with propofol and remifentanil on intraoperative target blood pressure maintenance

Interventions

A Group:Anesthesia depth monitoring assisted automated muti-closed-loop drug delivery
M Group:Standard anesthesia management

Sponsors

Department of Anesthesiology,Second Affiliated Hospital of Naval Medical University(Shanghai Changzheng Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Adult patients (age:18-70 years old) who were planned to receive arthroscopic knee surgery under TIVA in each center who meet the American Society of Anesthesiologists physical status (ASA grade) of I and II, with a body mass index (BMI) not less than 18.5 kg/m2 and below 30 kg/m2. The patients should be fully informed about the study and then give a written consent.

Exclusion criteria

Exclusion criteria: Patients who are70 years of age , ASA grade of III to V, those with a score lower than 24 points by Mini-Mental State Examination (MMSE) for cognitive function evaluation one day before surgery, use of atropine or vasoactive drugs (such as epinephrine, ephedrine, etc.) during intubation and skin incision, emergency surgery, patients assessed as difficult airway prior to surgery, those with known allergies to propofol, remifentanil or cisatracurium besilate, use of inhalation anesthesia or combination with other anesthesia methods such as epidural anesthesia, nerve block etc., patients diagnosed with brain diseases (such as epilepsy, autism, cognitive dysfunction), autonomic nervous system disorders, severe arrhythmia or a history of chronic pain before surgery, those with a history of alcoholism, drug abuse or hearing impairments, patients who need to receive anticholinergic medication before and/or during the study, pregnant or lactating women, and those assessed as unsuitable to participate in this study due to other reasons.

Design outcomes

Primary

MeasureTime frame
The percentage of time during the total anesthesia duration (from the start of anesthesia induction to the end of anesthesia at the end of surgery) in which the patients' MAP fluctuates within a minimal target range (±10% of the baseline).;

Secondary

MeasureTime frame
The time-weighted average of MAP (TWA-MAP) when the fluctuation of MAP is beyond±10% of baseline;The frequencies of cuff-related hypertension, hypertension and hypotension,as well as the numbers of times when anesthesiologist is needed to manually adjust BP.;The changes in HR and MAP at tracheal intubation (pre-TI, post-TI) and skin incision (pre-SI, post-SI) are compared to evaluate the differences in hemodynamic responses to nociceptive stimulation between the two anesthetic management modes ;The ability of BIS, PTi and WLi in predicting hemodynamic responses;The incidences of postoperative nausea and vomiting (PONV) and delirium within 24 hours after surgery;The doses of propofol and remifentanil per unit body weight and per time;

Countries

China

Contacts

Public ContactFu Hailong

Department of Anesthesiology,Second Affiliated Hospital of Naval Medical University, Shanghai, China

fuhailong1979@163.com+86 135 8576 0822

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026