A Phase 4 interventional study of Propofol and Ciprofol in Cholelithiasis and Postoperative Nausea and Vomiting, sponsored by Xi'an Aerospace General Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Xi'an Aerospace General Hospital · Phase 4, Interventional, and Prevention
This study is designed to compare three sedative medications used during general anesthesia for gallbladder removal surgery (laparoscopic cholecystectomy) and their effects on nausea and vomiting after surgery.
Background Nausea and vomiting after surgery (postoperative nausea and vomiting, PONV) is a common problem, affecting up to 75% of patients undergoing gallbladder surgery. It can cause discomfort, delay recovery, and lead to other complications. Three medications are commonly used to start and maintain anesthesia: propofol, ciprofol, and remimazolam. This study aims to find out which one is associated with the least nausea and vomiting.
Study Design
This is a prospective, randomized, controlled, single-blind clinical trial. A total of 114 adult patients scheduled for elective laparoscopic cholecystectomy at Xi'an Aerospace Hospital will be randomly assigned to one of three groups (38 patients each):
Propofol group Ciprofol group Remimazolam group All patients will receive the same anti-nausea prevention and pain control after surgery, regardless of their group.
Primary Outcome (Main Measure)
The percentage of patients who experience any nausea and/or vomiting within the first 24 hours after surgery.
Secondary Outcomes (Other Measures)
Percentage of patients who experience vomiting within 24 hours after surgery Percentage of patients who experience nausea within 24 hours after surgery Number of nausea, vomiting, and combined PONV episodes within 24 hours Pain level measured on a 0-10 visual analog scale (VAS) at 0, 6, 12, and 24 hours after surgery (0 = no pain, 10 = worst pain imaginable) Highest pain score reported within the first 24 hours after surgery Significance The results will help doctors choose the best sedative medication to reduce nausea and vomiting after gallbladder surgery, especially for patients who are at higher risk, such as women.
Background and rationale
Postoperative nausea and vomiting (PONV) is one of the most common complications following general anesthesia, occurring in 20-30% of the general surgical population and up to 53-72% in high-risk patients. PONV causes significant patient discomfort, prolongs post-anesthesia care unit stay, and may lead to complications including fluid and electrolyte imbalance, wound dehiscence, and aspiration pneumonia. Laparoscopic cholecystectomy (LC) is associated with a particularly high incidence of PONV (40-75%) due to the combined effects of pneumoperitoneum, carbon dioxide absorption, and vagal stimulation during visceral traction.
Propofol is the most widely used intravenous anesthetic agent and is known to possess direct antiemetic properties through suppression of the vomiting center and chemoreceptor trigger zone in the area postrema. However, propofol is associated with injection pain, hypotension, respiratory depression, and potential lipid metabolism disturbances. Two newer sedative agents have recently been approved for clinical use in China: ciprofol (HSK3486), a cyclopropyl structural analogue of propofol with approximately 5-fold greater affinity for GABAA receptors, offering reduced injection pain and improved hemodynamic stability; and remimazolam, an ultra-short-acting benzodiazepine acting on GABAA receptors with rapid onset, rapid recovery, minimal hemodynamic effects, and negligible respiratory depression. Its inactive metabolite and reversibility with flumazenil provide additional safety advantages.
To date, no prospective randomized controlled trial has directly compared the effects of propofol, ciprofol, and remimazolam on PONV in patients undergoing LC. This study aims to fill this evidence gap.
Study design
This is a prospective, randomized, controlled, single-blind clinical trial conducted in accordance with the CONSORT 2010 statement. The study will be conducted at Xi'an Aerospace Hospital. A total of 114 adult patients scheduled for elective LC under general anesthesia will be enrolled and randomly assigned in a 1:1:1 ratio to one of three groups (n=38 per group): propofol group, ciprofol group, or remimazolam group.
Sample size calculation
Sample size was estimated using PASS 21 software based on a pilot study of 33 patients (11 per group) who underwent LC at Xi'an Aerospace Hospital between June 1 and July 1, 2026. Using a chi-square test (Proportions → Contingency Table module) with α=0.05, power (1-β)=0.80, and df=2, the minimum required sample size was calculated as 91 patients. Accounting for an anticipated 20% dropout rate, the final planned sample size is 114 patients (38 per group).
Randomization and allocation concealment
A computer-generated block randomization sequence in a 1:1:1 ratio will be produced using SAS 9.0 software. Allocation assignments will be sealed in sequentially numbered opaque envelopes and opened in order by an anesthetic nurse not directly involved in the study, ensuring adequate concealment of the allocation sequence.
Anesthetic protocol
All enrolled patients will undergo preoperative assessment the day before surgery and provide written informed consent. On arrival in the operating room, standard monitoring will be established, including electrocardiography, non-invasive blood pressure, pulse oximetry (SpO2), nasopharyngeal temperature, and bispectral index (BIS) monitoring. All patients will receive intravenous ondansetron 8 mg and dexamethasone 10 mg as prophylactic antiemetic treatment.
Anesthesia induction: All patients will receive sufentanil citrate 0.5 μg/kg (Yichang Humanwell Pharmaceutical, Yichang, Hubei, China) and cisatracurium 0.15 mg/kg. The sedative agent will be administered according to group assignment: propofol 2 mg/kg (Yangtze River Pharmaceutical Group, Taizhou, Jiangsu, China) intravenously over ≥30 s; ciprofol 0.4 mg/kg (Haisco Pharmaceutical Group, Shenyang, Liaoning, China) intravenously over ≥30 s; or remimazolam 0.3 mg/kg (Yichang Humanwell Pharmaceutical, Yichang, Hubei, China) intravenously over ≥1 min. Once BIS reaches ≤60, preoxygenation via face mask will be performed for 3 min, followed by insertion of a supraglottic airway device and initiation of mechanical ventilation. After induction, bilateral subcostal and lateral transversus abdominis plane (TAP) blocks will be performed under ultrasound guidance using 0.3% ropivacaine 40 mL total (Shijiazhuang No.4 Pharmaceutical, Shijiazhuang, Hebei, China).
Anesthesia maintenance: All patients will receive continuous remifentanil infusion at 0.1-0.2 μg/kg/min for analgesia (Yichang Humanwell Pharmaceutical, Yichang, Hubei, China). Maintenance sedation will be administered per group: propofol 4-12 mg/kg/h; ciprofol 0.8-1.2 mg/kg/h; or remimazolam 0.2-1.0 mg/kg/h. Infusion rates will be titrated to maintain BIS values between 40 and 60. Cisatracurium besylate will be administered intermittently as needed for neuromuscular blockade. Ketorolac tromethamine 30 mg (Shandong New Time Pharmaceutical, Linyi, Shandong, China) will be given intravenously 5 min before surgery completion, after which all maintenance agents will be discontinued.
Postoperative analgesia: All patients will receive multimodal analgesia via patient-controlled intravenous analgesia (PCIA) pump. The PCIA formulation will comprise nalbuphine hydrochloride 1.5 mg/kg, ketorolac tromethamine 2 mg/kg, and ondansetron 16 mg diluted with normal saline to a total volume of 100 mL; background infusion rate 2 mL/h, bolus dose 2 mL, lockout interval 15 min, for 48 h. Intravenous ondansetron 8 mg will be administered as rescue antiemetic therapy for moderate-to-severe PONV.
Outcome measures
The primary outcome is the incidence of PONV (defined as nausea and/or vomiting) within 24 h postoperatively. PONV severity will be graded according to World Health Organization (WHO) criteria: Grade I, no nausea or retching; Grade II, mild nausea with abdominal discomfort but no vomiting; Grade III, nausea with retching but no expulsion of gastric contents; Grade IV, severe vomiting with expulsion of gastric contents requiring pharmacological intervention.
Secondary outcomes include: (1) incidence of vomiting within 24 h; (2) incidence of nausea within 24 h; (3) frequency of nausea, vomiting, and PONV episodes within 24 h; (4) visual analog scale (VAS) pain scores at 0, 6, 12, and 24 h postoperatively; and (5) peak VAS pain score within 24 h. Pain intensity will be assessed using a 0-10 VAS, where 0 = no pain and 10 = worst imaginable pain.
Statistical analysis
All statistical analyses will be performed using SPSS 27.0 software. Continuous variables will be assessed for normality. Normally distributed data will be presented as mean ± standard deviation (SD) and compared using one-way ANOVA with LSD post-hoc test for pairwise comparisons. Non-normally distributed data will be presented as median (interquartile range) and compared using the Kruskal-Wallis test. Categorical variables will be expressed as frequency (percentage) and compared using the chi-square test or Fisher's exact test as appropriate. Repeated measures data will be analyzed using repeated measures ANOVA. A multivariable logistic regression model will be constructed adjusting for age, sex, ASA classification, body mass index (BMI), and operation time to evaluate the independent associations between sedative agents and postoperative PONV outcomes. Spearman's rank correlation will be used to assess the relationship between postoperative pain scores and PONV frequency. All tests will be two-sided, with p \< 0.05 considered statistically significant.
189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.
This study's enrollment of 114 is above the median of 90 across 135 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →This is the only study on the registry with Xi'an Aerospace General Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive propofol for anesthesia induction and maintenance during elective laparoscopic cholecystectomy. All participants will also receive standardized perioperative care, including prophylactic antiemetics (ondansetron 8 mg and dexamethasone 10 mg), intraoperative analgesia with sufentanil and remifentanil, cisatracurium for neuromuscular blockade, ultrasound-guided transversus abdominis plane (TAP) block with 0.3% ropivacaine, and postoperative patient-controlled intravenous analgesia (PCIA). The primary and secondary outcomes will be assessed within 24 hours after surgery.
Drug: Propofol
Participants in this arm will receive ciprofol, a novel cyclopropyl analogue of propofol, for anesthesia induction and maintenance during elective laparoscopic cholecystectomy. All participants will also receive standardized perioperative care, including prophylactic antiemetics (ondansetron 8 mg and dexamethasone 10 mg), intraoperative analgesia with sufentanil and remifentanil, cisatracurium for neuromuscular blockade, ultrasound-guided transversus abdominis plane (TAP) block with 0.3% ropivacaine, and postoperative patient-controlled intravenous analgesia (PCIA). The primary and secondary outcomes will be assessed within 24 hours after surgery.
Drug: Ciprofol
Participants in this arm will receive remimazolam, an ultra-short-acting benzodiazepine, for anesthesia induction and maintenance during elective laparoscopic cholecystectomy. All participants will also receive standardized perioperative care, including prophylactic antiemetics (ondansetron 8 mg and dexamethasone 10 mg), intraoperative analgesia with sufentanil and remifentanil, cisatracurium for neuromuscular blockade, ultrasound-guided transversus abdominis plane (TAP) block with 0.3% ropivacaine, and postoperative patient-controlled intravenous analgesia (PCIA). The primary and secondary outcomes will be assessed within 24 hours after surgery.
Drug: Remimazolam
Drug: Propofol (Yangtze River Pharmaceutical Group, Taizhou, Jiangsu, China) Induction: 2 mg/kg intravenously over ≥ 30 seconds Maintenance: 4-12 mg/kg/h by continuous intravenous infusion, titrated to maintain BIS between 40 and 60
Drug: Ciprofol (HSK3486; Haisco Pharmaceutical Group, Shenyang, Liaoning, China) Induction: 0.4 mg/kg intravenously over ≥ 30 seconds Maintenance: 0.8-1.2 mg/kg/h by continuous intravenous infusion, titrated to maintain BIS between 40 and 60
Drug: Remimazolam besylate (Yichang Humanwell Pharmaceutical, Yichang, Hubei, China) Induction: 0.3 mg/kg intravenously over ≥ 1 minute Maintenance: 0.3-1.0 mg/kg/h by continuous intravenous infusion, titrated to maintain BIS between 40 and 60
Incidence of postoperative nausea and vomiting within 24 hours after surgery
The proportion of patients who experience nausea and/or vomiting within the first 24 hours after surgery. Postoperative nausea and vomiting (PONV) is defined as nausea and/or vomiting occurring within 24 hours postoperatively. Severity will be graded according to World Health Organization (WHO) criteria: Grade I, no nausea or retching; Grade II, mild nausea with abdominal discomfort but no vomiting; Grade III, nausea with retching but no expulsion of gastric contents; Grade IV, severe vomiting with expulsion of gastric contents requiring pharmacological intervention. Overall PONV incidence = (Grade II + Grade III + Grade IV cases) / total cases × 100%.
Time frame: 24 hours after surgery
Incidence of Nausea Within 24 Hours After Surgery
The proportion of patients who experience nausea (a subjective unpleasant sensation associated with the urge to vomit) within the first 24 hours after surgery.
Time frame: 24 hours postoperatively
Incidence of Vomiting Within 24 Hours After Surgery
The proportion of patients who experience vomiting (expulsion of gastric contents) within the first 24 hours after surgery.
Time frame: 24 hours postoperatively
Number of Nausea Episodes Within 24 Hours After Surgery
The total number of discrete nausea episodes experienced by each patient during the first 24 hours after surgery. An episode is defined as a distinct period of nausea separated from other episodes by at least 5 minutes of no nausea.
Time frame: 24 hours postoperatively
Number of Vomiting Episodes Within 24 Hours After Surgery
The total number of discrete vomiting episodes (forceful expulsion of gastric contents) experienced by each patient during the first 24 hours after surgery. An episode is defined as a distinct vomiting event separated from other vomiting events by at least 5 minutes.
Time frame: 24 hours postoperatively
Peak Visual Analog Scale (VAS) Pain Score Within 24 Hours After Surgery
The highest pain intensity score recorded within the first 24 hours after surgery, assessed using a 0-10 visual analog scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain. Pain scores are evaluated at 0, 6, 12, and 24 hours postoperatively; the peak score is the maximum of these four measurements for each patient.
Time frame: 24 hours postoperatively
Plan to share: No — "Individual participant data will not be shared due to institutional data protection policies and patient privacy considerations."
Ran from Aug 2026 to primary completion in Sep 2026, 1 month.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Propofol · Ciprofol · Remimazolam