Clinical Observation of Ciprofol for Anesthesia Induction

Xiumei Song

Status and phase: Not yet enrolling; Phase 4

Conditions: Hemodynamic Instability; Pain; Anesthesia

Treatments: Drug: Propofol; Drug: Ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05706337

YXLL-KY-2022(060)

Details and patient eligibility

About

To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.

Full description

90 elderly patients undergoing noncardiac surgery were randomly divided into propofol group and ciprofol group, who were given propofol 1 ~ 2mg/kg or ciprofol 0.2-0.5mg/kg during anesthesia induction respectively. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and BIS values at various time points during anesthesia induction were collected. At the same time, rates of injection pain, muscle fasciculation, arrhythmia, cough and perioperative hepatic and renal functions were compared between the two groups. The primary outcomes were the fluctuations in hemodynamic parameters during induction. The secondary outcome were adverse reactions, BIS values and changes of hepatic and renal functions during induction.

Enrollment: 90 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ASA physical status Ⅰ-Ⅲ
2. Age over 65 years;
3. Body mass index (BMI) 20 ~ 30 kg/m2 ;
4. Elective noncardiac surgery;

Exclusion criteria

1. The patient or his/her family refused to participate in the clinical trial;
2. Severe heart, lung, liver or kidney dysfunction;
3. Expected difficult airway, requiring awake tracheal intubation;
4. Those who are allergic to the drugs used in this study;
5. Unsuccessful tracheal intubation twice;
6. Patients with mental illness or impaired consciousness;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

propofol group

Active Comparator group

Description:

According to grouping，patients were premeditated with injection of Propofol 1-2mg / kg IV . If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is \>60, propofol 0.5mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil.

Treatment:

Drug: Propofol

ciprofol group

Experimental group

Description:

According to grouping，patients were premeditated with injection of ciprofol 0.2-0.5mg/kg IV. If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is \>60, ciprofol 0.1mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil in both groups.

Treatment:

Drug: Ciprofol