Effect of high versus low dose intravenous dexamethason on complications in the immediate postoperative setting after periacetabular osteotomy- a randomized, double-blind, controlled trial.

Effect of high versus low dose intravenous dexamethason on complications in the immediate postoperative setting after periacetabular osteotomy- a randomized, double-blind, controlled trial. - DEX-GANZ

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000544-17-DK

Enrollment

Registered

2017-02-10

Start date

2017-03-28

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications after operation for hip dysplasia MedDRA version: 19.1 Level: LLT Classification code 10063175 Term: Hip dysplasia System Organ Class: 100000004850

Interventions

Trade Name: Dexamethason Product Name: Dexamethason Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: DEXAMETHASONE CAS Number: 50-02-2 Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age at or above 18 years Scheduled periacetabular osteotomy in the study period Signed informed constent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Insuline dependent diabetes Ongoing/chronic treatment with systemic corticosteroids Ongoing treatment with immunosuppressive therapy Pregnancy Breastfeeding Allergies towards standard medication or study medication

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effects of high versus low dose glucorticoids on pain after periacetabular osteotomy;Secondary Objective: To investigate the effects of high versus low dose glucorticoids on complications after periacetabular osteotomy, pain, nausea, circulatory/respiratory problems, use of analgesics, quality of sleep;Primary end point(s): proportion of patients with moderate/severe pain in the post anasthesia care unit;Timepoint(s) of evaluation of this end point: 24 hours	—

Measure

Time frame

Main Objective: To investigate the effects of high versus low dose glucorticoids on pain after periacetabular osteotomy;Secondary Objective: To investigate the effects of high versus low dose glucorticoids on complications after periacetabular osteotomy, pain, nausea, circulatory/respiratory problems, use of analgesics, quality of sleep;Primary end point(s): proportion of patients with moderate/severe pain in the post anasthesia care unit;Timepoint(s) of evaluation of this end point: 24 hours

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Secondary

Measure	Time frame
Secondary end point(s): 1.Discharge score at operating theather and arrival to postanaesthesia care unit or ward. 2.Complications the first 24 hours post surgery or until discharge 3.Lenght of stay 4.Pain and nausea the first 5 days post surgery 5.Use of pain medication the first 5 days post surgery 6.Quality of sleep the first 5 days post surgery ;Timepoint(s) of evaluation of this end point: 1. 24 h 2. 24 h 3. until discharge 4-6. 5 days	—

Measure

Time frame

Secondary end point(s): 1.Discharge score at operating theather and arrival to postanaesthesia care unit or ward. 2.Complications the first 24 hours post surgery or until discharge 3.Lenght of stay 4.Pain and nausea the first 5 days post surgery 5.Use of pain medication the first 5 days post surgery 6.Quality of sleep the first 5 days post surgery ;Timepoint(s) of evaluation of this end point: 1. 24 h 2. 24 h 3. until discharge 4-6. 5 days

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Countries

Denmark

Contacts

Public ContactKristin Julia Steinthorsdottir

Rigshospitalet

kristin.julia.steinthorsdottir.01@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026