Effect of Dexamethasone Shortly Before Surgery on the Intraoperative Dose of Remifentanil
1 other identifier
interventional
94
1 country
5
Brief Summary
This explorative post hoc analysis included patients randomized in the DEX-2-TKA trial (NCT03506789) who were operated under general anesthesia with remifentanil and propofol. Patients having general anesthesia with sevoflurane were excluded. As the two groups receiving preoperative dexamethasone were identical at the time of outcome assessment, they were merged to one and were compared with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2018
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2020
CompletedFirst Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
August 12, 2021
CompletedAugust 12, 2021
August 1, 2021
1.5 years
July 13, 2021
August 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Intraoperative use of remifentanil
mg
During surgery (from surgical incision till last suture)
Secondary Outcomes (3)
Intraoperative use of propofol
During surgery (from surgical incision till last suture)
Anesthesia depth
During surgery (from surgical incision till last suture)
Time in post-anesthesia care unit (PACU)
Time at the PACU (from arrival at the PACU untill transfer to orthopedic ward), approximated 0-4 hours
Study Arms (2)
Treatment A+B
ACTIVE COMPARATOR24 mg dexamethasone i.v. perioperatively
Placebo
PLACEBO COMPARATORPlacebo (isotonic saline) i.v. perioperatively
Interventions
Eligibility Criteria
You may qualify if:
- Participation in DEX-2-TKA (NCT03506789)
- General anesthesia
You may not qualify if:
- Spinal anestehesia
- Use of sevoflurane
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Naestved Hospitallead
- Bispebjerg Hospitalcollaborator
Study Sites (5)
Gildhøj Privathospital
Brøndby, 2605, Denmark
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Sjællands Universitetshospital, Køge
Køge, 4600, Denmark
Næstsved Sygehus
Næstved, 4700, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Related Publications (1)
Gantzel M, Gasbjerg KS, Hagi-Pedersen D, Meyhoff CS, Olsen MH, Mathiesen O, Jakobsen JC, Lunn TH. Effect of dexamethasone on intraoperative remifentanil dose in total knee arthroplasty surgery under general anaesthesia. Acta Anaesthesiol Scand. 2022 Oct;66(9):1070-1076. doi: 10.1111/aas.14118. Epub 2022 Aug 4.
PMID: 35908167DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kasper S Gasbjerg, MD
Naestved Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2021
First Posted
August 12, 2021
Study Start
September 14, 2018
Primary Completion
March 11, 2020
Study Completion
June 7, 2020
Last Updated
August 12, 2021
Record last verified: 2021-08