Colorectal Diseases Undergoing Elective Laparoscopic Colorectal Surgerycrp-lcNCT07903389
Comparison of Ciprofol, Remimazolam and Propofol in Laparoscopic Colorectal Surgery
A study testing Ciprofol, Remimazolam and Propofol in people with Colorectal Diseases Undergoing Elective Laparoscopic Colorectal Surgery, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
This is a single-center, prospective, parallel randomized controlled trial. A total of 180 patients aged 18-75 years undergoing elective laparoscopic colorectal surgery with ASA physical status Ⅰ-Ⅲ will be enrolled and randomly assigned in a 1:1:1 ratio to ciprofol group, remimazolam group or propofol group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Diseases Undergoing Elective Laparoscopic Colorectal Surgery
- What is being tested?
- Ciprofol, Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old
- Scheduled for elective laparoscopic colorectal surgery
- ASA physical status Ⅰ-Ⅲ
- Able to understand and complete QoR-15 assessment preoperatively
Who cannot join
- Severe cardiac, pulmonary, hepatic or renal dysfunction
- Pre-existing psychiatric disease, cognitive dysfunction or inability to complete follow-up
- Long-term history of opioid or sedative medication use
- Known allergy to any of the study drugs
- Postoperative ICU admission and inability to complete postoperative assessment
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: The Effect of Different Intravenous Anesthetics on Postoperative Recovery Quality in Patients Undergoing Elective Laparoscopic Colorectal Surgery: A Single-Center, Prospective, Randomized Controlled Trial
This is a single-center, prospective, parallel randomized controlled trial. A total of 180 patients aged 18-75 years undergoing elective laparoscopic colorectal surgery with ASA physical status Ⅰ-Ⅲ will be enrolled and randomly assigned in a 1:1:1 ratio to ciprofol group, remimazolam group or propofol group. All patients receive standardized background anesthesia regimen including dexmedetomidine, sufentanil, rocuronium and remifentanil. The primary outcome is the QoR-15 score at postoperative day 1. Secondary outcomes include intraoperative hemodynamic parameters, anesthesia recovery indicators, postoperative VAS pain scores, opioid consumption and perioperative adverse events. The study was approved by the Institutional Review Board of The First Affiliated Hospital of Zhengzhou University (approval number: 2023-KY-0137-002). Written informed consent will be obtained from each participant before enrollment.
- Being tested
- Ciprofol, Remimazolam, Propofol
- Keywords
- Anesthesia; Ciprofol; Remimazolam; Propofol; Laparoscopic colorectal surgery; Postoperative recovery; QoR-15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
Ciprofol injection, intravenous anesthesia induction and maintenance for laparoscopic colorectal surgery.
RemimazolamDrug
Remimazolam injection, intravenous anesthesia induction and maintenance for laparoscopic colorectal surgery.
PropofolDrug
Propofol injection, intravenous anesthesia induction and maintenance for laparoscopic colorectal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol group (C group) | Experimental | Patients receive ciprofol for anesthesia induction and maintenance. Induction: ciprofol 0.4 mg/kg IV; maintenance: 0.8-2.0 mg/kg/h continuous infusion. All patients receive standardized anesthesia background regimen including dexmedetomidine, sufentanil, rocuronium, remifentanil. Postoperative standardized PCIA is applied. Receives: Drug: Ciprofol |
| Remimazolam group (R group) | Experimental | Patients receive remimazolam for anesthesia induction and maintenance. Induction: remimazolam 12 mg/kg/h IV; maintenance: 1-2 mg/kg/h continuous infusion. All patients receive standardized anesthesia background regimen including dexmedetomidine, sufentanil, rocuronium, remifentanil. Postoperative standardized PCIA is applied. Receives: Drug: Remimazolam |
| Propofol group (P group) | Experimental | Patients receive propofol for anesthesia induction and maintenance. Induction: propofol 1.5-2.0 mg/kg IV; maintenance: 4-12 mg/kg/h continuous infusion. All patients receive standardized anesthesia background regimen including dexmedetomidine, sufentanil, rocuronium, remifentanil. Postoperative standardized PCIA is applied. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Quality of Recovery Scale-15 (QoR-15) score
QoR-15 consists of 15 items covering 5 domains: pain, physical comfort, emotional state, psychological support, and physical independence. Total score ranges from 0 to 150; higher score indicates better postoperative recovery. Assessed at postoperative day 1.
Measured: Postoperative day 1
Secondary outcomes (3)
Mean arterial pressure (MAP)
Description: Mean arterial pressure measured during perioperative period
Measured: Before anesthesia induction, After tracheal intubation, 30 minutes after surgical incision, At the end of surgery, At extubation
Cough Visual Analogue Scale (VAS) pain score
Cough-induced visual analogue scale (VAS) pain scores were assessed at 6 hours, 12 hours, 24 hours, and 48 hours postoperatively. Cumulative opioid consumption was recorded at 24 hours and 48 hours after surgery. The VAS score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: 6, 12, 24, and 48 hours after surgery
Perioperative adverse events
Incidence of hypotension, bradycardia, postoperative nausea and vomiting, respiratory depression, delayed emergence, postoperative delirium.
Measured: From anesthesia induction to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Feb 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Diseases Undergoing Elective Laparoscopic Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Du Yingying, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903389
- Sponsor's protocol ID
- anes-2023-001
- Acronym
- crp-lc
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) including baseline characteristics, intraoperative hemodynamic data, postoperative recovery scores, pain scores and adverse event data will be available upon reasonable request after publication of the primary results. The data will be shared after completion of the study and publication of the main manuscript. Requests should be directed to the principal investigator. Data will be provided after signing a data access agreement.
Publications
Liu Z, Hong J, Huang X, Wu D. Olfactory cleft mucus galectin-10 predicts olfactory loss in chronic rhinosinusitis. Ann Allergy Asthma Immunol. 2023 Mar;130(3):317-324.e1. doi: 10.1016/j.anai.2022.07.014. Epub 2022 Jul 21.
PubMed 35870756Gondalia V, Choi DH, Lee SC, Nam CH, Hwang BH, Ahn HS, Ong AC, Park HY, Jung KA. Periprosthetic supracondylar femoral fractures following total knee arthroplasty: clinical comparison and related complications of the femur plate system and retrograde-inserted supracondylar nail. J Orthop Traumatol. 2014 Sep;15(3):201-7. doi: 10.1007/s10195-014-0287-x. Epub 2014 Apr 1.
PubMed 24687558
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Intravenous Anesthetics on Postoperative Recovery Quality in Patients Undergoing Elective Laparoscopic Colorectal Surgery: A Single-Center, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07903389
- Acronym / sponsor ID
- crp-lc / anes-2023-001
- Keywords
- Anesthesia; Ciprofol; Remimazolam; Propofol; Laparoscopic colorectal surgery; Postoperative recovery; QoR-15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, prospective, parallel randomized controlled trial. A total of 180 patients aged 18-75 years undergoing elective laparoscopic colorectal surgery with ASA physical status Ⅰ-Ⅲ will be enrolled and randomly assigned in a 1:1:1 ratio to ciprofol group, remimazolam group or propofol group. All patients receive standardized background anesthesia regimen including dexmedetomidine, sufentanil, rocuronium and remifentanil. The primary outcome is the QoR-15 score at postoperative day 1. Secondary outcomes include intraoperative hemodynamic parameters, anesthesia recovery indicators, postoperative VAS pain scores, opioid consumption and perioperative adverse events. The study was approved by the Institutional Review Board of The First Affiliated Hospital of Zhengzhou University (approval number: 2023-KY-0137-002). Written informed consent will be obtained from each participant before enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ciprofol group (C group) | Experimental | Drug: CiprofolPatients receive ciprofol for anesthesia induction and maintenance. Induction: ciprofol 0.4 mg/kg IV; maintenance: 0.8-2.0 mg/kg/h continuous infusion. All patients receive standardized anesthesia background regimen including dexmedetomidine, sufentanil, rocuronium, remifentanil. Postoperative standardized PCIA is applied. |
| Remimazolam group (R group) | Experimental | Drug: RemimazolamPatients receive remimazolam for anesthesia induction and maintenance. Induction: remimazolam 12 mg/kg/h IV; maintenance: 1-2 mg/kg/h continuous infusion. All patients receive standardized anesthesia background regimen including dexmedetomidine, sufentanil, rocuronium, remifentanil. Postoperative standardized PCIA is applied. |
| Propofol group (P group) | Experimental | Drug: PropofolPatients receive propofol for anesthesia induction and maintenance. Induction: propofol 1.5-2.0 mg/kg IV; maintenance: 4-12 mg/kg/h continuous infusion. All patients receive standardized anesthesia background regimen including dexmedetomidine, sufentanil, rocuronium, remifentanil. Postoperative standardized PCIA is applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years old
- Scheduled for elective laparoscopic colorectal surgery
- ASA physical status Ⅰ-Ⅲ
- Able to understand and complete QoR-15 assessment preoperatively
Key exclusion criteria (5 listed)
- Severe cardiac, pulmonary, hepatic or renal dysfunction
- Pre-existing psychiatric disease, cognitive dysfunction or inability to complete follow-up
- Long-term history of opioid or sedative medication use
- Known allergy to any of the study drugs
- Postoperative ICU admission and inability to complete postoperative assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofolCiprofol injection, intravenous anesthesia induction and maintenance for laparoscopic colorectal surgery. | Drug | Ciprofol group (C group) |
| RemimazolamRemimazolam injection, intravenous anesthesia induction and maintenance for laparoscopic colorectal surgery. | Drug | Remimazolam group (R group) |
| PropofolPropofol injection, intravenous anesthesia induction and maintenance for laparoscopic colorectal surgery. | Drug | Propofol group (P group) |
Primary outcome
Postoperative Quality of Recovery Scale-15 (QoR-15) score
Time frame: Postoperative day 1
QoR-15 consists of 15 items covering 5 domains: pain, physical comfort, emotional state, psychological support, and physical independence. Total score ranges from 0 to 150; higher score indicates better postoperative recovery. Assessed at postoperative day 1.
3 secondary outcomes
Mean arterial pressure (MAP)
Time frame: Before anesthesia induction, After tracheal intubation, 30 minutes after surgical incision, At the end of surgery, At extubation
Cough Visual Analogue Scale (VAS) pain score
Time frame: 6, 12, 24, and 48 hours after surgery
Perioperative adverse events
Time frame: From anesthesia induction to 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 35870756Liu Z, Hong J, Huang X, Wu D. Olfactory cleft mucus galectin-10 predicts olfactory loss in chronic rhinosinusitis. Ann Allergy Asthma Immunol. 2023 Mar;130(3):317-324.e1. doi: 10.1016/j.anai.2022.07.014. Epub 2022 Jul 21.
- Background: PubMed 24687558Gondalia V, Choi DH, Lee SC, Nam CH, Hwang BH, Ahn HS, Ong AC, Park HY, Jung KA. Periprosthetic supracondylar femoral fractures following total knee arthroplasty: clinical comparison and related complications of the femur plate system and retrograde-inserted supracondylar nail. J Orthop Traumatol. 2014 Sep;15(3):201-7. doi: 10.1007/s10195-014-0287-x. Epub 2014 Apr 1.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) including baseline characteristics, intraoperative hemodynamic data, postoperative recovery scores, pain scores and adverse event data will be available upon reasonable request after publication of the primary results. The data will be shared after completion of the study and publication of the main manuscript. Requests should be directed to the principal investigator. Data will be provided after signing a data access agreement.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ciprofol, Remimazolam and Propofol in people with Colorectal Diseases Undergoing Elective Laparoscopic Colorectal Surgery, run by The First Affiliated Hospital of Zhengzhou University at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Quality of Recovery Scale-15 (QoR-15) score (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 NCT07903389, which also lists 2 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 29 Oct 2026.