A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy

NCT07758803 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: XAHT-PONV-2026
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholelithiasis; Postoperative Nausea and Vomiting

Keywords

postoperative nausea and vomiting; propofol; ciprofol; remimazolam; laparoscopic cholecystectomy; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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%.

  24 hours after surgery

Secondary Outcomes (5)

• Incidence of Nausea Within 24 Hours After Surgery

  24 hours postoperatively

• Incidence of Vomiting Within 24 Hours After Surgery

  24 hours postoperatively

• Number of Nausea Episodes Within 24 Hours After Surgery

  24 hours postoperatively

• Number of Vomiting Episodes Within 24 Hours After Surgery

  24 hours postoperatively

• Peak Visual Analog Scale (VAS) Pain Score Within 24 Hours After Surgery

  24 hours postoperatively

Study Arms (3)

Propofol Group

EXPERIMENTAL

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

Ciprofol Group

EXPERIMENTAL

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

Remimazolam Group

EXPERIMENTAL

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

Interventions

Propofol DRUG

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

Propofol Group

Ciprofol DRUG

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

Ciprofol Group

Remimazolam DRUG

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

Remimazolam Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years, either sex American Society of Anesthesiologists (ASA) physical status classification I-III Scheduled for elective laparoscopic cholecystectomy under general anesthesia Able to understand the study protocol and provide written informed consent Not concurrently enrolled in other clinical studies

You may not qualify if:

• Known hypersensitivity to any anesthetic agent used in the study Severe cardiac, pulmonary, hepatic, or renal dysfunction Active systemic infectious disease Psychiatric disorder or use of sedative agents within the preceding two weeks Refusal to participate

Sponsors & Collaborators

• Xi'an Aerospace General Hospital: lead

Study Sites (1)

Xi'an Aerospace Hospital

Xi'an, Shaanxi, 710100, China

Location

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MeSH Terms

Conditions

Cholelithiasis; Postoperative Nausea and Vomiting

Interventions

Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; remimazolam

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Lei Ma, MD, PhD

  Second Affiliated Hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Zhang, BM

CONTACT

+8613259708740; myselfspace123@126.com

Lei Ma, MD, PhD

CONTACT

+8613519134023; malei0214@xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In this single-blind clinical trial, participants were randomly assigned to one of three groups using a computer-generated block randomization sequence. Allocation concealment was achieved using sequentially numbered, sealed, opaque envelopes. An anesthetic nurse who was not involved in the study placed the group assignment information into the corresponding numbered envelope. The person obtaining informed consent and the participants were unaware of the group assignment. The anesthesiologists administering the interventions were not blinded to the group allocation. Outcome assessors, data collectors responsible for postoperative follow-up, and data analysts were blinded to the group assignment throughout the study period.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a three-arm, parallel-group randomized controlled trial. Participants are assigned to one of three groups (propofol, ciprofol, or remimazolam) in a 1:1:1 ratio and remain in their assigned group throughout the study. A parallel design is appropriate because each participant undergoes only one surgical procedure, making a crossover design unsuitable.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)