Anesthetics, Intravenous, Hypnotics and Sedatives, Postoperative Complications, Postoperative Recovery
Conditions
Keywords
Ciprofol, Propofol
Brief summary
Ciprofol is a novel 2,6-disubstituted phenol derivatives and is proved have much higher potency and tighter binding toward ɣ-aminobutyric acid type A (GABAA) receptor while maintaining a fast on-set and recovery time compared to propofol. Except lower incidence of hypotension and respiratory depression, it has no injection pain and infusion syndrome compared with propofol. There is no study to investigate overall postoperative functional recovery in patients receiving total intravenous anesthesia (TIVA) using ciprofol yet. However, according to study, early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. Therefore, the purpose of this study is to determine whether there is any difference in the quality of postoperative recovery between ciprofol-based and propofol-based TIVA in elderly patients undergoing gastrointestinal surgery. The QoR-15 questionnaire score, pain, nausea/vomiting, and the frequency of complications are evaluated and compared between the two groups.
Interventions
DRUGCiprofol
Ciprofol group will be started and maintained total intravenous anesthesia with ciprofol and remifentanil
DRUGPropofol
Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
participants were anesthetized and were unaware of the grouping. Care providers did not know the grouping. Specific investigators who did the intervention were aware of the grouping. The outcome assessors and the data analyzers did not know the grouping.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective laparoscopic surgery under endotracheal intubation and general anesthesia * American Society of Anesthesiologists (ASA) classification: I to III; * Age ≥ 60 years, BMI \< 30 kg/m2; * Unconscious speech audiovisual impairment or unable to cooperate; * Informed consent has been signed.
Exclusion criteria
* Taking any sedative, opioid, or sleep aid drugs; * Psychiatric or neurological disorder; * Allergic to ciprofol, propofol or soy, or a family history of malignant hyperthermia; * Severe liver and kidney dysfunction; * Operation duration \< 2 hours; * Plan to the intensive care unit with tracheal catheter; * Have participated in this study or other clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1 | Postoperative day 1 | Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value: 0, maximum value: 150, the higher the score, the better the result) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of injection pain | during anesthesia induction | Record the incidence of injection pain ( yes or no) |
| Hemodynamic change | During the operation | Record the mean arterial pressure (MAP) at different points, including before induction, after induction, immediately after intubation, at the beginning of surgery, at the end of anesthesia, immediately after extubation, and before leaving the room |
| Vasoactive agents | from start of surgery to end of surgery | Percentage of patients needed vasoactive agents during anesthesia |
| Tracheal extubation time | From stopping ciprofol or propofol infusion to awake and withdrawal of tracheal tube, approximately 30 minutes | Time from cessation of main anaesthetics to tracheal extubation |
| Postoperative sedation score | Immediately after awake，approximately 1 hour after surgery | Monitored by the sedation scale called Sedation-Agitation Scale (SAS). SAS is a medical scale used to measure the agitation or sedation level of a person.The score ranges from 1 to 7 |
| Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2 | Postoperative day 2 | Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2 (minimum value: 0, maximum value: 150, the higher the score, the better the result) |
| Postoperative nausea and vomiting | Immediately after awake, approximately 1 hour after surgery | Postoperative nausea and vomiting will be evaluated by PONV (Post Operative Nausea And Vomiting) score (no : 0, vomit: 4) |
| First exhaust time | 24 hours after end of surgery, approximately 24 hours | Record the first exhaust time After the operation |
| Hospital stay | From end of surgery to discharge from hospital, on an average of 7 days | days of hospital stay |
| Postoperative complications | From end of surgery to discharge from hospital, on an average of 7 days | Various complications occurred during hospitalization |
| Adverse event | From end of surgery to discharge from hospital, on an average of 7 days | Percentage of adverse events occurred during hospitalization |
| Postoperative pain score | Immediately after awake, approximately 1 hour after surgery | postoperative pain score measured by 11-point VAS (Visual Analogue Scale) score (minimum : 0, maximum : 10, the lower the score, the lesser pain) |
Countries
China
Contacts
Primary ContactWanwan Yang
Backup ContactHaopeng Zhang
Outcome results
None listed