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Anesthetics, IntravenousNCT05843383

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

A study testing Ciprofol and Propofol in people with Anesthetics, Intravenous and Postoperative Complications, run by Xijing Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Ciprofol and Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
2 sitesChina
Study dates
16 May 2023to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Wanwan Yang contact

029-84775343

yangwanwan2017@163.com

Haopeng Zhang contact

029-84775343

haopeng.zhang@foxmail.com

China2 sites, 2 recruiting

  • Xijing Hospital

    Xi'an, Shaanxi, 710032

    Wanwan Yang, 029-84775343, yangwanwan2017@163.com

    Haopeng Zhang

    Not yet recruiting

  • Xijing Hospital

    Xi'an, Shaanxi

    Wanwan Yang

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Ciprofol, Propofol
Keywords
Ciprofol, Propofol
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CiprofolDrug

    Also called HSK3486

    Ciprofol group will be started and maintained total intravenous anesthesia with ciprofol and remifentanil

  • PropofolDrug

    Also called 2,6-diisopropylphenol

    Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil

Study groups in NCT05843383
Study groupRoleWhat they receive
Ciprofol groupExperimentalCiprofol-based total intravenous anesthesia is given for maintenance of general anesthesia
Receives: Drug: Ciprofol
Propofol groupExperimentalPropofol-based total intravenous anesthesia is given for maintenance of general anesthesia
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Postoperative day 1

Secondary outcomes (12)

  1. 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)

    Measured: Postoperative day 2

  2. Incidence of injection pain

    Record the incidence of injection pain ( yes or no)

    Measured: during anesthesia induction

  3. 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

    Measured: During the operation

  4. Vasoactive agents

    Percentage of patients needed vasoactive agents during anesthesia

    Measured: from start of surgery to end of surgery

  5. Tracheal extubation time

    Time from cessation of main anaesthetics to tracheal extubation

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

  6. 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

    Measured: Immediately after awake，approximately 1 hour after surgery

  7. 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)

    Measured: Immediately after awake, approximately 1 hour after surgery

  8. Postoperative nausea and vomiting

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

    Measured: Immediately after awake, approximately 1 hour after surgery

  9. First exhaust time

    Record the first exhaust time After the operation

    Measured: 24 hours after end of surgery, approximately 24 hours

  10. Hospital stay

    days of hospital stay

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

  11. Postoperative complications

    Various complications occurred during hospitalization

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

  12. Adverse event

    Percentage of adverse events occurred during hospitalization

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start16 May 2023
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05843383
Sponsor's protocol ID
KY20222308-C-1
Status last verified
May 2023
First submitted
3 Apr 2023
Last updated
9 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28430430

  • 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.

    PubMed 32415708

  • 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.

    PubMed 33896305

  • 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.

    PubMed 21406529

  • 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.

    PubMed 35157236

  • 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.

    PubMed 35033845

Questions about this trial

What is this clinical trial studying?

A study testing Ciprofol and Propofol in people with Anesthetics, Intravenous and Postoperative Complications, run by Xijing Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wanwan Yang (029-84775343, yangwanwan2017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1 (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05843383, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.

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