CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Continuous intravenous analgesia +3 moredrug
Likely dose
Continuous intravenous analgesia 100 mgfrom 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/NCT04521556
NCT04521556Phase 4Completed

Is Postoperative Quality of Recovery After Unilateral Nephrectomy Related to the Type of Anesthesia and Analgesia?

University Hospital of Split·interventional·Posted Aug 20, 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 7 related conditions. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Different modality of anesthesia and analgesia could influence a postoperative quality of recovery (QoR). This study is exploring early QoR after unilateral nephrectomy in the two groups of anesthesia. The first group had a light general anesthesia with thoracic 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 PostedAug 20, 2020
Enrollment StartApr 1, 2019
Primary CompletionApr 1, 2021
Study CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 5.9 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 analgesiaprocedure

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.