Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587505
Status:
COMPLETED
Last Update Posted:
2021-09-30
First Post:
2020-10-07
Brief Title:
Effect of Epidural Anesthesia and Analgesia on Quality of Recovery After Radical Prostatectomy
Sponsor:
University Hospital of Split
Organization:
University Hospital of Split
Study Overview
Official Title:
Is Postoperative Quality of Recovery After Radical Prostatectomy Related to the Type of Anesthesia and Analgesia
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QoR
Brief 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
Detailed Description:
All participants were premedicated with diazepam 5 mg 12 hours and 1 hour before surgery Thromboprophylaxis 4000 - 6000 IU depending on the body weight was given at least 12 hours before surgery All participants were warmed to prevent unintended hypothermia Participants were allocated by permuted block randomisation into one of two groups general anesthesia group and epidural anesthesia The randomisation list was obtained from R program version 353 The group allocations were contained in a closed envelope that were opened before surgery after the completed enrollment procedure All patients and infusions were wormed to prevent unintended hypothermia Induction of general anesthesia was with midazolam 25 mg fentanyl 100 μg propofol 1-2 mgkg and vecuronium 01 mgkg Balanced crystalloid fluids were used to treat hypovolemia Additionally 6 Hydroxyethyl starch was used before blood transfusion products to treat profound hypovolemia Blood transfusions were given according to blood loss and clinical situation Bradycardia was treated with atropine Hypotension was treated with ephedrine boluses Anti-inflammatory drug metamizole dipyrone 25 g was given intravenously before the end of the surgery and after 12 hours after the surgery Neostigmine 25 mg with atropine 1 mg was used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery Participants were placed for one day in a urology high care unit provided with constant and vigilant nurse care Crystalloid infusions were used for maintaining diuresis Gastroprotection was done with pantoprazole 40 mg Metoclopramid 10 mg was given for postoperative nausea and vomiting PONV The postoperative QoR was evaluated with three QoR scales Scales for pain anxiety and PONV were also examined The 36-Item Short Form Survey SF-36 questionnaire evaluated quality of life one month before and one month after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None