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

Postoperative Complications Clinical Trial

Official title:

Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery in Elderly Patients Undergoing Laparoscopic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843383
• Other study ID #: KY20222308-C-1
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2023
• Source: Xijing Hospital
• Contact: Wanwan Yang
• Phone: 029-84775343
• Email: yangwanwan2017[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthetics, Intravenous
• Hypnotics and Sedatives
• Postoperative Complications
• Postoperative Recovery

Intervention

Drug:
• Ciprofol
Ciprofol group will be started and maintained total intravenous anesthesia with ciprofol and remifentanil
• Propofol
Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Bakhtiari E, Mousavi SH, Gharavi Fard M. Pharmacological control of pain during propofol injection: a systematic review and meta-analysis. Expert Rev Clin Pharmacol. 2021 Jul;14(7):889-899. doi: 10.1080/17512433.2021.1919084. Epub 2021 Jun 1. — View Citation

Bian Y, Zhang H, Ma S, Jiao Y, Yan P, Liu X, Ma S, Xiong Y, Gu Z, Yu Z, Huang C, Miao L. Mass balance, pharmacokinetics and pharmacodynamics of intravenous HSK3486, a novel anaesthetic, administered to healthy subjects. Br J Clin Pharmacol. 2021 Jan;87(1):93-105. doi: 10.1111/bcp.14363. Epub 2020 Aug 3. — View Citation

Campfort M, Cayla C, Lasocki S, Rineau E, Leger M. Early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. J Clin Anesth. 2022 Jun;78:110638. doi: 10.1016/j.jclinane.2021.110638. Epub 2022 Jan 13. — View Citation

Jalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110. — View Citation

Luo Z, Tu H, Zhang X, Wang X, Ouyang W, Wei X, Zou X, Zhu Z, Li Y, Shangguan W, Wu H, Wang Y, Guo Q. Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study. CNS Drugs. 2022 Mar;36(3):301-313. doi: 10.1007/s40263-021-00890-1. Epub 2022 Feb 14. — View Citation

Qin L, Ren L, Wan S, Liu G, Luo X, Liu Z, Li F, Yu Y, Liu J, Wei Y. Design, Synthesis, and Evaluation of Novel 2,6-Disubstituted Phenol Derivatives as General Anesthetics. J Med Chem. 2017 May 11;60(9):3606-3617. doi: 10.1021/acs.jmedchem.7b00254. Epub 2017 Apr 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Postoperative day 1
Secondary	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)	Postoperative day 2
Secondary	Incidence of injection pain	Record the incidence of injection pain ( yes or no)	during anesthesia induction
Secondary	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	During the operation
Secondary	Vasoactive agents	Percentage of patients needed vasoactive agents during anesthesia	from start of surgery to end of surgery
Secondary	Tracheal extubation time	Time from cessation of main anaesthetics to tracheal extubation	From stopping ciprofol or propofol infusion to awake and withdrawal of tracheal tube, approximately 30 minutes
Secondary	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	Immediately after awake,approximately 1 hour after surgery
Secondary	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)	Immediately after awake, approximately 1 hour after surgery
Secondary	Postoperative nausea and vomiting	Postoperative nausea and vomiting will be evaluated by PONV (Post Operative Nausea And Vomiting) score (no : 0, vomit: 4)	Immediately after awake, approximately 1 hour after surgery
Secondary	First exhaust time	Record the first exhaust time After the operation	24 hours after end of surgery, approximately 24 hours
Secondary	Hospital stay	days of hospital stay	From end of surgery to discharge from hospital, on an average of 7 days
Secondary	Postoperative complications	Various complications occurred during hospitalization	From end of surgery to discharge from hospital, on an average of 7 days
Secondary	Adverse event	Percentage of adverse events occurred during hospitalization	From end of surgery to discharge from hospital, on an average of 7 days