Gallbladder Removal Clinical Trials

Clinical trials related to Gallbladder Removal Procedure

A Prospective, Randomized, Controlled, Single-Blind Clinical Trial Comparing the Effects of Propofol, Ciprofol, and Remimazolam on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Xi'an Aerospace Hospital
RECRUITING
Xi'an
Contact Information
Primary
Liang Zhang, BM
myselfspace123@126.com
+8613259708740
Backup
Lei Ma, MD, PhD
malei0214@xjtu.edu.cn
+8613519134023
Time Frame
Start Date: 2026-08-15
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 114
Treatments
Experimental: Propofol Group
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.
Experimental: Ciprofol Group
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.
Experimental: Remimazolam Group
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.
Related Therapeutic Areas
Sponsors
Leads: Xi'an Aerospace General Hospital

This content was sourced from clinicaltrials.gov