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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000505-20-DK

Enrollment

Registered

2017-02-17

Start date

2017-03-28

Completion date

Unknown

Last updated

2020-02-01

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

Conditions

Post operative complications after open nephrectomy, heminephrectomy and kidney resection (pain, nausea, respiratory/circulatory problems, sedation, quality of sleep) MedDRA version: 19.1 Level: LLT Classification code 10036278 Term: Postoperative complications NOS System Organ Class: 100000004863

Interventions

Product Name: Dexamethason Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: DEXAMETHASONE CAS Number: 50-02-2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age at or above 18 years Scheduled nephrectomy 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 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44

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 effect of high versus low dose intravenous dexamethasone on complications in the immediate postoperative setting after nephrectomy, heminephrectomy. Main objective complications demanding treatment in the post anaesthesia care unit (PACU) (pain, nausea).; Secondary Objective: Pain and nausea the first five days after operation. Quality of sleep the first five days after operation. ;Primary end point(s): Number of patients with complications in the PACU according to discharge criteria;Timepoint(s) of evaluation of this end point: <24 hours	—

Measure

Time frame

Main Objective: To investigate the effect of high versus low dose intravenous dexamethasone on complications in the immediate postoperative setting after nephrectomy, heminephrectomy. Main objective complications demanding treatment in the post anaesthesia care unit (PACU) (pain, nausea).; Secondary Objective: Pain and nausea the first five days after operation. Quality of sleep the first five days after operation. ;Primary end point(s): Number of patients with complications in the PACU according to discharge criteria;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 7. complications/readmissions the first 30 days after operation ; Timepoint(s) of evaluation of this end point: 1. 24 h 2. 24 h 3. until discharge 4-6. 5 days 7. 130days	—

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 7. complications/readmissions the first 30 days after operation ; Timepoint(s) of evaluation of this end point: 1. 24 h 2. 24 h 3. until discharge 4-6. 5 days 7. 130days

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Countries

Denmark

Contacts

Public ContactKristin Julia Steinthorsdottir

Rigshospitalet

kristin.julia.steinthorsdottir.01@regionh.dk004531666112

Outcome results

None listed

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