CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
Dexamethasone phosphate +1 moredrug
Likely dose
Dexamethasone phosphate 24 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/NCT04762381
NCT04762381N/ACompleted

Effect of 24 mg Dexamethasone Preoperatively on Surgical Stress, Pain and Recovery in Robotic-assisted Laparoscopic Hysterectomy

Herning Hospital·interventional·Posted Feb 21, 2021·Updated Jun 4, 2024

In Brief

A clinical study evaluating Dexamethasone phosphate and Placebo for Inflammatory Response and 4 related conditions. Completed, enrolled 109 participants across 1 site.

Detailed Summary

Robotic-assisted hysterectomy is an alternative to laparoscopic surgery as part of a minimal invasive regimen. Several treatment strategies are followed to improve the overall outcome and minimize surgical stress. Glucocorticoids provide significant analgesic and antiemetic effects but its role in a fast-track, multi-modal setting is not settled when discharge is planned within 24-36 hours. This study will evaluate in a randomized trial the effect of a single dose of 24 mg dexamethasone on women undergoing robotic-assisted hysterectomy with regard to surgical stress measured by c-reactive protein as primary outcome and, further, other stress markers like white blood cells. The postoperative recovery will be registered in validated charts and questionnaires for pain and analgesic use, quality of recovery, incontinence, sexual and work life. Furthermore, in a sub-analysis, transcriptional profiling will be applied to explore, which parts of the innate and cellular immune system is activated to explore the mechanisms of surgical stress response. The hypothesis is that women undergoing robotic hysterectomy would benefit from peroperative glucocorticoid treatment on important life qualities like pain, fatigue, freedom of medications and resuming work and sexual activities. Further, future adjuvant peroperative regimens may be able to target the stress response in a more appropriate way

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 21, 2021
Enrollment StartJun 1, 2022
Primary CompletionFeb 6, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.4 years ago

Interventions

Dexamethasone phosphatedrug

24 mg dexamethasone infused peroperatively

Placeboother

Saline