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.
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: 1. The time of lose consciousness(LOC) during the induction, The Time and dosage of additional drug, and the BIS value during the induction process. 2. The incidence of adverse events such as injection pain, body movement, muscle twitching, hypotension, hypertension, bradycardia or tachycardia, cough and bronchospasm during induction. 3. 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) . 4. the recovery time of consciousness (ROC), extubation time, PACU stay time, postoperative hospital stay time. 5. Incidence of postoperative nausea and vomiting, incidence of postoperative agitation and delayed recovery, and intraoperative awareness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
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.
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.
Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
RECRUITINGHemodynamic fluctuations: Systolic blood pressure(SBP)
Systolic blood pressure(SBP) during anesthesia induction and surgery.
Time frame: during anesthesia induction,perioperative
Hemodynamic fluctuations: Diastolic blood pressure(DBP)
Diastolic blood pressure(DBP) during anesthesia induction and surgery.
Time frame: during anesthesia induction,perioperative
Hemodynamic fluctuations: mean blood pressure (MAP)
MAP during anesthesia induction and surgery.
Time frame: during anesthesia induction,perioperative
Hemodynamic fluctuations: Heart rate (HR)
Heart rate (HR) during anesthesia induction and surgery.
Time frame: during anesthesia induction,perioperative
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)
Time frame: 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.
Time frame: during induction
quality of recovery
quality of recovery 15(QOR15) score at pre-operation(Preop) 、 postoperation day 1 ,postoperation of day2
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Time frame: 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
Time frame: 2 hours after surgery
Incidence of intraoperative awareness
Brice Questionnaire was used to assess the occurrence of intraoperative awareness.
Time frame: 2 hours after surgery