drugset / Trial / NCT01275911

Non-opioid Analgesia for Fast-track Surgery

NCT01275911

RandomizedParallel-groupDouble-blindTreatment

Summary

In this randomized observer-blinded trial the analgesic efficacy of intravenous esmolol, as alternative to intraoperative opioids, is tested in patients undergoing laparoscopic prostatectomy and upper gastrointestinal surgery (such as Nissen fundoplication). The purpose of this study is to determine whether intravenous esmolol improves postoperative analgesia and accelerate the surgical recovery. We hypothesize that patients receiving intravenous esmolol will consume less analgesic in the postoperative period, will have less opioid-related side effects and will recover their functional status faster then patients receiving intravenous esmolol. Patients will be stratified according to the type of surgical procedure in 2 arms: 40 patients with prostate cancer and undergoing elective laparoscopic prostatectomy, and 40 patients with gastro-esophageal reflux undergoing upper gastrointestinal surgery (Nissen funduplication) will be enrolled. Patients will receive total intravenous anesthesia with propofol and esmolol (Esmolol group, n=20 in each arm) or propofol and remifentanil (Remifentanil Group, n=20 in each arm).

Timeline

Start
2009-01
Primary completion
2010-07
Completion
2010-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Esmolol Other / unclassified 5 ug/kg Intravenous
Subject Esmolol Other / unclassified 15 ug/kg Intravenous
Comparator Remifentanil Small molecule 0.025 ug/kg
Comparator Remifentanil Small molecule 0.25 ug/kg

Indications