CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Esmolol +1 moredrug
Likely dose
Esmolol 1mg/Kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01275911
NCT01275911N/ACompleted

Fast-track Laparoscopic Surgery. The Effect of Anesthetic Technique

In Brief

A clinical study evaluating Esmolol and Remifentanil for Pain. Completed, enrolled 40 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2011
Enrollment StartJan 1, 2009
Primary CompletionJul 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.5 years ago

Interventions

Esmololdrug

Induction of anesthesia: 1mg/Kg; Maintenance during surgery: 5-15 mcg/kg/min

Remifentanildrug

At the induction of anesthesia: 1mcg/Kg; Maintenance during surgery: 0.025-0.25mcg/kg/min