Dexamethasone and Robotic-assisted Hysterectomy

NCT04762381 | Completed

• 1 other identifier: Robotic surgery and steroid
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Inflammatory Response; Pain, Postoperative; Nausea, Postoperative; Incontinence; Sexual Behavior

Keywords

inflammatory response; surgical stress; leucocytes; IL-6; mRNA transcription; incontinence; sexual function; work life

Outcome Measures

Primary Outcomes (1)

• level of c-reactive protein (CRP)

  c-reactive protein measured in mg/l

  0-36 hours

Secondary Outcomes (7)

• level of IL-6

  0-36 hours

• Leucucytes

  0-36 hours

• mRNA

  0-36 hours

• Incontinence

  0-14 days

• Sexual function

  0-14 days

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

24 mg dexamethasone as single dose intravenously peroperatively

Drug: Dexamethasone phosphate

Placebo

PLACEBO COMPARATOR

saline infusion intravenously in a single dose

Other: Placebo

Interventions

Dexamethasone phosphate DRUG

24 mg dexamethasone infused peroperatively

Also known as: glucocorticoid

Dexamethasone

Placebo OTHER

Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meno-metrorrhagia,
• dysmenorrhea,
• fibroma,
• dysplasia,
• dysmenorrhea,
• ability in Danish writing

You may not qualify if:

• current treatment with glucocorticoids, opioids and NSAID analgesics,
• diabetes,
• current treatment of malignant disease,
• renal or hepatic disease,
• unable to communicate in Danish language.

Sponsors & Collaborators

• Herning Hospital: lead
• Hospital of Southern Jutland: collaborator

Study Sites (1)

Gyn. Dept.;Aabenraa Hospital, Sygehus Sønderjylland

Aabenraa, 6400, Denmark

Location

Related Publications (6)

• Lunn TH, Kristensen BB, Andersen LO, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3.

  PMID: 21131371 BACKGROUND

• De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.

  PMID: 21799397 BACKGROUND

• Jokela RM, Ahonen JV, Tallgren MK, Marjakangas PC, Korttila KT. The effective analgesic dose of dexamethasone after laparoscopic hysterectomy. Anesth Analg. 2009 Aug;109(2):607-15. doi: 10.1213/ane.0b013e3181ac0f5c.

  PMID: 19608838 BACKGROUND

• Steinthorsdottir KJ, Kehlet H, Aasvang EK. Surgical stress response and the potential role of preoperative glucocorticoids on post-anesthesia care unit recovery. Minerva Anestesiol. 2017 Dec;83(12):1324-1331. doi: 10.23736/S0375-9393.17.11878-X. Epub 2017 Jun 12.

  PMID: 28607335 BACKGROUND

• Lirk P, Thiry J, Bonnet MP, Joshi GP, Bonnet F; PROSPECT Working Group. Pain management after laparoscopic hysterectomy: systematic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019 Apr;44(4):425-436. doi: 10.1136/rapm-2018-100024. Epub 2019 Feb 3.

  PMID: 30914471 BACKGROUND

• Wijk L, Nilsson K, Ljungqvist O. Metabolic and inflammatory responses and subsequent recovery in robotic versus abdominal hysterectomy: A randomised controlled study. Clin Nutr. 2018 Feb;37(1):99-106. doi: 10.1016/j.clnu.2016.12.015. Epub 2016 Dec 23.

  PMID: 28043722 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Sexual Behavior

Interventions

dexamethasone 21-phosphate; Glucocorticoids

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Behavior

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Britta Frederiksen, PhD

  Gyn. Dept. Aabenraa Hospital, Sygehus Sønderjylland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinded, results enteree into RedCap, logged and masked for participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, double blinded trial

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: June 1, 2022
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2025
• Access Criteria: personal contact

Locations

DK (1)