Effect of Ciprofol Infusion for Induction and Maintenance on Hemodynamics and Postoperative Recovery

Study Overview
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Brief Summary
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To study the Effect of Ciprofol Infusion for Induction and Maintenance of anesthesia on Hemodynamics and Postoperative Recovery in Patients Undergoing Thoracoscopic Lobectomy:a randomized, controlled trial.

Detailed Description
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Patients undergoing Thoracoscopic Lobectomy aged 18 65 years old were randomly assigned to Group P and Group C . Group P was given propofol 2   2.5mg/kg, group C was given ciprofol 0.4   0.5mg/kg, if bispectral index(BIS) value ≤60 during anesthesia induction, cisatracurium 0.2mg/kg and sufentanil 0.5μg/kg were injected intravenously, endotracheal intubation was performed after the improvement of muscle relaxation. If the BIS value was greater than 60, propofol was added intravenously 1mg/kg each time or ciprofol 0.2mg/kg each time, and the interval of administration was greater than 1min, until BIS≤60. Cisatracurium and sufentanil were injected intravenously, followed by endotracheal intubation.Then propofol was maintained in group P at 4-12 mg/kg/h and remifentanil was maintained at 0.1-0.3 ug/kg/min .Ciprofol was maintained in Group C at 0.8-2.5 mg/kg/h and remifentanil was maintained at 0.1-0.3 ug/kg/min . Intermittent addition of cisatracurium. Sufentanil was added as required, and total dosage of Sufentanil was 0.7ug   1ug/kg. BIS was kept at 40   60 during the surgery, and infusion drugs were stopped at the end of the operation. The patients were Transfer to Postanesthesia care unit(PACU) after the operation. The primary outcomes were the fluctuations in hemodynamic parameters during induction and the surgery. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP),heart rate (HR) and BIS values at various time points were collected. The secondary outcome were as follows: The time of lose consciousness（LOC） during the induction, The Time and dosage of additional drug, and the BIS value during the induction process. The incidence of adverse events such as injection pain, body movement, muscle twitching, hypotension, hypertension, bradycardia or tachycardia, cough and bronchospasm during induction. quality of recovery 15（QOR15） score at pre-operation（Preop） 、on the first day of postoperation （POD1）and on the second day of postoperation （POD2） . the recovery time of consciousness (ROC）, extubation time, PACU stay time, postoperative hospital stay time. Incidence of postoperative nausea and vomiting, incidence of postoperative agitation and delayed recovery, and intraoperative awareness.

Official Title
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Effect of Ciprofol Infusion for Induction and Maintenance on Hemodynamics and Postoperative Recovery in Patients Undergoing Thoracoscopic Lobectomy : a Randomized, Controlled Trial

Conditions
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Hemodynamics, Postoperative Recovery, Anesthesia

Intervention / Treatment
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* Drug: propofol
* Drug: ciprofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology (ASA)Ⅰ～Ⅱ grade; 18-65 years; Body mass index (BMI) 20-30kg/m2 ; Scheduled for thoracoscopic lobectomy under general anesthesia; Exclusion Criteria: Refused to participate in the clinical study; Predictable airway difficulties requiring awake intubation; Allergy to the drugs which were used in this study; Tracheal intubation failed for twice; Patients with mental diseases or consciousness disorder; long-term use of sedatives or Antidepressants; Patients who are participating in other clinical studies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol group<br>According to grouping，patients were premeditated with injection of Propofol 2-2.5mg / 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, propofol 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.Then propofol was maintained in group P at 4-12 mg/kg/h and remifentanil was maintained at 0.1-0.3 ug/kg/min .BIS was kept at 40   60 during the surgery, and infusion drugs were stopped at the end of the operation. The patients were Transfered to Postanesthesia care unit(PACU) after the operation. | Drug: propofol<br>* propofol 2～2.5mg/kg was used for anesthesia induction. propofol is an intravenous sedative-hypnotic and a short-acting GABAA receptor agonist. It activates GABAergic neurons by enhancing chloride ion influx. It is used for anesthesia of induction and maintenance.<br>|
| Experimental: ciprofol group<br>Group C was given ciprofol 0.4   0.5mg/kg, if bispectral index(BIS) value ≤60 during anesthesia induction, cisatracurium 0.2mg/kg and sufentanil 0.5μg/kg were injected intravenously, endotracheal intubation was performed after the improvement of muscle relaxation. If the BIS value was greater than 60, ciprofol 0.2mg/kg each time, and the interval of administration was greater than 1min, until BIS≤60. Cisatracurium and sufentanil were injected intravenously, followed by endotrachealintubation.Ciprofol was maintained in Group C at 0.8-2.5 mg/kg/h and remifentanil was maintained at 0.1-0.3 ug/kg/min . Intermittent addition of cisatracurium,Sufentanil was added as required, and total dosage of Sufentanil was 0.7ug   1ug/kg. BIS was kept at 40   60 during the surgery, and infusion drugs were stopped at the end of the operation. The patients were Transfered to Postanesthesia care unit(PACU) after the operation. | Drug: ciprofol<br>* Ciprofol 0.4～0.5mg/kg was used for anesthesia induction. Ciprofol is an intravenous sedative-hypnotic and a short-acting GABAA receptor agonist. It activates GABAergic neurons by enhancing chloride ion influx. It is used for anesthetic induction and maintenance agents include rapid induction of general anesthesia, rapid recovery of consciousness, minimal residual effects on the central nervous system and less injection pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic fluctuations: Systolic blood pressure(SBP) | Systolic blood pressure(SBP) during anesthesia induction and surgery. | during anesthesia induction，perioperative | 
| Hemodynamic fluctuations: Diastolic blood pressure(DBP) | Diastolic blood pressure(DBP) during anesthesia induction and surgery. | during anesthesia induction，perioperative | 
| Hemodynamic fluctuations: mean blood pressure (MAP) | MAP during anesthesia induction and surgery. | during anesthesia induction，perioperative | 
| Hemodynamic fluctuations: Heart rate (HR) | Heart rate (HR) during anesthesia induction and surgery. | during anesthesia induction，perioperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of lose consciousness（LOC） during the induction | The time of lose consciousness（LOC） during the induction was defined as from the drug was administered until the patients loss of consciousness(when the BIS≤60) | during anesthesia induction | 
| The incidence of adverse events during induction | The incidence of adverse events such as injection pain, body movement, muscle twitching, hypotension, hypertension, bradycardia or tachycardia, cough and bronchospasm during induction. | during induction | 
| quality of recovery | quality of recovery 15（QOR15） score at pre-operation（Preop） 、 postoperation day 1 ,postoperation of day2 | pre-operation, postoperation of day 1 ,postoperation of day2 | 
| postoperative recovery | Incidence of postoperative nausea and vomiting was record use Classification of nausea and vomiting | 2 hours after surgery | 
| Incidence of intraoperative awareness | Brice Questionnaire was used to assess the occurrence of intraoperative awareness. | 2 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Recovery, Ciprofol, Hemodynamics, propofol