Clinical trial
Effect of Ciprofol Infusion for Induction and Maintenance on Hemodynamics and Postoperative Recovery in Patients Undergoing Thoracoscopic Lobectomy : a Randomized, Controlled Trial
Name
20221128C
Description
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.
Trial arms
Trial start
2023-04-10
Estimated PCD
2024-10-31
Trial end
2024-12-01
Status
Recruiting
Phase
Early phase I
Treatment
propofol
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.
Arms:
propofol group
ciprofol
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.
Arms:
ciprofol group
Size
126
Primary endpoint
Hemodynamic fluctuations: Systolic blood pressure(SBP)
during anesthesia induction，perioperative
Hemodynamic fluctuations: Diastolic blood pressure(DBP)
during anesthesia induction，perioperative
Hemodynamic fluctuations: mean blood pressure (MAP)
during anesthesia induction，perioperative
Hemodynamic fluctuations: Heart rate (HR)
during anesthesia induction，perioperative
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 126, 'type': 'ESTIMATED'}}
Updated at
2024-01-10
1 organization
2 products
3 indications
Organization
Xiumei SongProduct
propofolIndication
HemodynamicsIndication
Postoperative RecoveryIndication
AnesthesiaProduct
ciprofol