CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
Postoperative epidural analgesia +3 moredrug
Likely dose
Postoperative epidural analgesia 4 mlfrom record
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Search/NCT04587505
NCT04587505Phase 4Completed

Is Postoperative Quality of Recovery After Radical Prostatectomy Related to the Type of Anesthesia and Analgesia?

University Hospital of Split·interventional·Posted Oct 14, 2020·Updated Sep 30, 2021

In Brief

A Phase 4 clinical trial evaluating Epidural anesthesia with light general anesthesia, Postoperative epidural analgesia, and 2 other interventions for Anesthesia and 8 related conditions. Completed, enrolled 61 participants across 1 site.

Detailed Summary

Postoperative quality of recovery (QoR) could be related to anesthesia and postoperative analgesia. This study is exploring early QoR after radical prostatectomy in the two groups of anesthesia. The first group had a light general anesthesia with lumbal epidural anesthesia and postoperative epidural analgesia with morphine and ropivacaine. The second group had general anesthesia and a continuous postoperative analgesia with tramadol. The postoperative QoR was evaluated 24 hours after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCroatia
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedOct 14, 2020
Enrollment StartApr 1, 2019
Primary CompletionApr 1, 2021
Study CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 5.7 years ago

Interventions

Epidural anesthesia with light general anesthesiaprocedure

Epidural anaesthesia: mixture of ropivacaine 6.5 mg/ ml and fentanyl 8.3 μg/ml. Light general anesthesia: isoflurane in mixture of 50/50 of nitrous oxide and oxygen to achieve Minimum alveolar concentration between 0.6 and 0.8.

Postoperative epidural analgesiadrug

Before the end of operation was given 4 ml of the mixture of ropivacaine 4.4 mg/ml and morphine 0.8mg/ ml. Epidural analgesia was continued for next 24 hours with a mixture of ropivacaine 2.2 mg/ml and morphine 0.4 mg/ml.

General anesthesiaprocedure

Maintaining general anesthesia: nitrous oxide and oxygen in mixture 50/50 and isoflurane to achieve minimum alveolar concentration between 0.8 and 1. Fentanyl loading dose: 6-8 μg/kg. Additional fentanyl doses were given incrementally.

Continuous intravenous analgesiadrug

Tramadol 100 mg in the first hour followed by tramadol 300 mg continuously for the next 24 hours.