Clinical Trials Logo

Clinical Trial Summary

Surgical pain refers to pain that occurs immediately after surgery, including physical pain and visceral pain. Thus, it severely challenges the proper use of analgesics for patients undergoing laparoscope gastrointestinal surgery to clinicians. Nalbuphine is a mixed agonist-antagonist opioid. The investigators hypothesized that the clinical effect of nalbuphine in combination with dexmedetomidine might be different from that of sufentanil in combination with dexmedetomidine. So, the investigators performed a nalbuphine and dexmedetomidine dose finding study, for the patient controlled anaesthesia (PCA) after the laparoscopic gastrointestinal surgery, to establish their 95% effective dose (ED95). The investigators then compared the clinical effect and adverse events of the newly established dosing regimen of nalbuphine combined with dexmedetomidine, to the equivalent dosing of sufentanil combined with dexmedetomidine, in the same patient population.


Clinical Trial Description

Surgical pain refers to pain that occurs immediately after surgery, including physical pain and visceral pain. Appropriate perioperative analgesia is a fundamental component of enhanced recovery after surgery. Especially, 45% of postoperative patients experience inadequate pain after gastrointestinal surgery, and uncontrolled postoperative pain prompts respiratory distress, delays wound healing, and a potentially eventual transition from acute to chronic pain problems. Thus, it severely challenges the proper use of analgesics for patients undergoing laparoscope gastrointestinal surgery to clinicians. Sufentanil is one of the most common opioid used in patient-controlled analgesia (PCA), it may induce many adverse events including respiratory depression, nausea, vomiting, constipation, urinary retention, pruritus, and drowsiness. Many drugs have been combined with dexmedetomidine in PCA to augment analgesic effect or to reduce the adverse events. Nalbuphine is a mixed agonist-antagonist opioid. Nalbuphine derives its analgesic and sleep-producing effects through agonism at the kappa-opioid receptor with fewer opioid-induced adverse effects. some articles show that it also has the potential to attenuate the mu-opioid receptor-related adverse events. The investigators hypothesized that the clinical effect of nalbuphine in combination with dexmedetomidine might be different from that of sufentanil in combination with dexmedetomidine. Unfortunately, the optimal dosing of nalbuphine combined with dexmedetomidine for the PCIA after the laparoscopic gastrointestinal surgery, has not been determined. So, the investigators performed a nalbuphine and dexmedetomidine dose finding study, for the PCIA after the laparoscopic gastrointestinal surgery, to establish their 95% effective dose (ED95). The investigators then compared the clinical effect and adverse events of the newly established dosing regimen of nalbuphine combined with dexmedetomidine, to the equivalent dosing of sufentanil combined with dexmedetomidine, in the same patient population. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05445024
Study type Interventional
Source Qianfoshan Hospital
Contact Meng Lv
Phone 15169105373
Email qylvmeng@163.com
Status Recruiting
Phase N/A
Start date January 1, 2023
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT04852016 - Optimizing the Consent Process for Emergent Laparoscopic Cholecystectomy N/A
Recruiting NCT04546230 - Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy. N/A
Completed NCT06098105 - Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics N/A
Not yet recruiting NCT05662735 - Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up Phase 4
Completed NCT02455752 - Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach. N/A
Recruiting NCT04295473 - Reduced Port Laparoscopic Gastrectomy for Gastric Cancer N/A
Recruiting NCT03785743 - Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma N/A
Not yet recruiting NCT05416866 - Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery Phase 4
Not yet recruiting NCT05427266 - Laparoscopic Transversus Abdominis Plane Block (LTAP) for Appendicectomy Versus Standard Port Site Treatment N/A
Completed NCT06166069 - Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study
Completed NCT06396845 - Assessing the Benefits of Robotic and Laparoscopic Surgery for Mid and Low Rectal Cancer in Patients: The Charlson Comorbidity Index (CCI)
Completed NCT03974841 - Cornual Wedge Resection Outcome
Completed NCT05259488 - Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy
Completed NCT04467710 - Laparoscopic Treatment of Common Bile Duct Stones : What Are the Limits and When Should we Call the Endoscopist ?
Not yet recruiting NCT06258317 - Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty N/A
Recruiting NCT04512560 - Structured Remote Surgical Coaching to Improve Operative Performance in Laparoscopic Cholecystectomy N/A
Completed NCT04694950 - Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery
Recruiting NCT05667181 - The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surgery for Rectal Cancer N/A
Completed NCT06454253 - Short- and Long-term Outcomes of Robotic vs Laparoscopic Right Colon Cancer: a 10-year Single-center Retrospective Study
Not yet recruiting NCT03224364 - Solo and Non-solo Approach for Laparoscopic Appendectomy (SOLOAP) N/A