Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery

Xijing Hospital280 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

280

Conditions

Anesthetics, Intravenous Postoperative Complications

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Quality of Recovery(QoR)-15 questionnaire score at 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)

Time frame: Postoperative day 1

Secondary Outcomes

Quality of Recovery(QoR)-15 questionnaire score at 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)

Time frame: Postoperative day 2

Incidence of injection pain

Record the incidence of injection pain ( yes or no)

Time frame: during anesthesia induction

Hemodynamic change

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

Time frame: During the operation

Vasoactive agents

Percentage of patients needed vasoactive agents during anesthesia

Time frame: from start of surgery to end of surgery

Tracheal extubation time

Time from cessation of main anaesthetics to tracheal extubation

Time frame: From stopping ciprofol or propofol infusion to awake and withdrawal of tracheal tube, approximately 30 minutes

Postoperative sedation score

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

Time frame: Immediately after awake，approximately 1 hour after surgery

Postoperative pain score

postoperative pain score measured by 11-point VAS (Visual Analogue Scale) score (minimum : 0, maximum : 10, the lower the score, the lesser pain)

Time frame: Immediately after awake, approximately 1 hour after surgery

Postoperative nausea and vomiting

Postoperative nausea and vomiting will be evaluated by PONV (Post Operative Nausea And Vomiting) score (no : 0, vomit: 4)

Time frame: Immediately after awake, approximately 1 hour after surgery

First exhaust time

Record the first exhaust time After the operation

Time frame: 24 hours after end of surgery, approximately 24 hours

Hospital stay

days of hospital stay

Time frame: From end of surgery to discharge from hospital, on an average of 7 days

Postoperative complications

Various complications occurred during hospitalization

Time frame: From end of surgery to discharge from hospital, on an average of 7 days

Adverse event

Percentage of adverse events occurred during hospitalization

Time frame: From end of surgery to discharge from hospital, on an average of 7 days

Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts