Perioperative PainPhase 4NCT05002361
Effect of Dexamethasone Shortly Before Surgery on the Intraoperative Dose of Remifentanil
A Phase 4 study testing Dexamethasone and Isotonic saline in people with Perioperative Pain, run by Naestved Hospital at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Pain
- What is being tested?
- Dexamethasone and Isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 5 sitesDenmark
- Study dates
- 14 Sep 2018to 7 Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in DEX-2-TKA (NCT03506789)
- General anesthesia
Who cannot join
- Spinal anestehesia
- Use of sevoflurane
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Gildhøj Privathospital
Brøndby, 2605
Bispebjerg Hospital
Copenhagen, 2400
Sjællands Universitetshospital, Køge
Køge, 4600
Næstsved Sygehus
Næstved, 4700
Odense Universitetshospital
Odense, 5000
About this study
Official title: Effect of Dexamethasone Shortly Before Surgery on the Intraoperative Dose of Remifentanil in Total Knee Arthroplasty Patients Operated Under General Anesthesia: A Post-hoc Sub-study Analysis of the Randomized DEX-2-TKA Trial
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.
Read the detailed description
The DEX-2-TKA was a randomized, blinded, placebo-controlled, multicenter trial in participants undergoing primary TKA conducted to investigate the effects of dexamethasone on morphine consumption, levels of postoperative pain, and harm. The methodology has been described in detail in the primary publication (ref), the protocol article and in the statistical analysis plan. In short, the trial was conducted at one private and four public Danish hospitals. Patients were randomized into one of three groups receiving either: Dexamethasone + placebo, dexamethasone + dexamethasone or placebo + placebo in a 1:1:1 ratio. The first dose of trial medication (intravenous dexamethasone 24 mg or placebo) was administered immediately after onset of anesthesia. Twenty-four hours after end of surgery, the second dose (dexamethasone 24 mg or placebo) was administered.
As the two groups receiving preoperative dexamethasone were identical at the time of outcome assessment for thi post-hoc analysis, they were merged to one and were compared with placebo yielding a ratio of 2:1 between the groups recieving dexamethsone and the placebo group.
Patients received either spinal anesthesia or general anesthesia (remifentanil and propofol were preferred). Before end of surgery all patients received ondansetron iv 4 mg. For patients in general anesthesia, sufentanil (0.3 μg/kg) was administered. All participants were provided with a patient-controlled analgesia pump (morphine 1 mg/mL, bolus 2 mg, lock-out 6 minutes, no background infusion) for 24 hours postoperatively. Additional boluses of 2 mg morphine on participant request were allowed the first hour after cessation of anesthesia. All participants received a protocolled non-opioid analgesic pain alleviation regime comprised of oral paracetamol 1 g and ibuprofen 400 mg given 1 hour before and every 6 hours after surgery and the surgeon administered local infiltration analgesia intraoperatively according to a standardized regimen.
The present explorative post hoc analysis included patients randomized in the DEX-2-TKA trial who were operated under general anesthesia with remifentanil and propofol. Patients having general anesthesia with sevoflurane were excluded.
- Conditions
- Perioperative Pain
- Being tested
- Dexamethasone, Isotonic saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
24 mg intravenous Dexamethasone (6 ml)
Isotonic salineDrug
6 ml of isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment A+B | Active comparator | 24 mg dexamethasone i.v. perioperatively Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Placebo (isotonic saline) i.v. perioperatively Receives: Drug: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative use of remifentanil
mg
Measured: During surgery (from surgical incision till last suture)
Secondary outcomes (3)
Intraoperative use of propofol
mg
Measured: During surgery (from surgical incision till last suture)
Anesthesia depth
Measured with bispectral index (BIS) - only for patients at Næstved
Measured: During surgery (from surgical incision till last suture)
Time in post-anesthesia care unit (PACU)
Minutes
Measured: Time at the PACU (from arrival at the PACU untill transfer to orthopedic ward), approximated 0-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start14 Sep 2018
- Primary completion11 Mar 2020
- Study completion7 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Sponsor
- Investigators
- Kasper S Gasbjerg, MD, Principal investigator, Naestved Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002361
- Sponsor's protocol ID
- SM1-MG-2021
- Status last verified
- Aug 2021
- First submitted
- 13 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35908167
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone Shortly Before Surgery on the Intraoperative Dose of Remifentanil in Total Knee Arthroplasty Patients Operated Under General Anesthesia: A Post-hoc Sub-study Analysis of the Randomized DEX-2-TKA Trial
- ClinicalTrials.gov ID
- NCT05002361
- Acronym / sponsor ID
- SM1-MG-2021
- Conditions
- Perioperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 7 Jun 2020 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The DEX-2-TKA was a randomized, blinded, placebo-controlled, multicenter trial in participants undergoing primary TKA conducted to investigate the effects of dexamethasone on morphine consumption, levels of postoperative pain, and harm. The methodology has been described in detail in the primary publication (ref), the protocol article and in the statistical analysis plan. In short, the trial was conducted at one private and four public Danish hospitals. Patients were randomized into one of three groups receiving either: Dexamethasone + placebo, dexamethasone + dexamethasone or placebo + placebo in a 1:1:1 ratio. The first dose of trial medication (intravenous dexamethasone 24 mg or placebo) was administered immediately after onset of anesthesia. Twenty-four hours after end of surgery, the second dose (dexamethasone 24 mg or placebo) was administered.
As the two groups receiving preoperative dexamethasone were identical at the time of outcome assessment for thi post-hoc analysis, they were merged to one and were compared with placebo yielding a ratio of 2:1 between the groups recieving dexamethsone and the placebo group.
Patients received either spinal anesthesia or general anesthesia (remifentanil and propofol were preferred). Before end of surgery all patients received ondansetron iv 4 mg. For patients in general anesthesia, sufentanil (0.3 μg/kg) was administered. All participants were provided with a patient-controlled analgesia pump (morphine 1 mg/mL, bolus 2 mg, lock-out 6 minutes, no background infusion) for 24 hours postoperatively. Additional boluses of 2 mg morphine on participant request were allowed the first hour after cessation of anesthesia. All participants received a protocolled non-opioid analgesic pain alleviation regime comprised of oral paracetamol 1 g and ibuprofen 400 mg given 1 hour before and every 6 hours after surgery and the surgeon administered local infiltration analgesia intraoperatively according to a standardized regimen.
The present explorative post hoc analysis included patients randomized in the DEX-2-TKA trial who were operated under general anesthesia with remifentanil and propofol. Patients having general anesthesia with sevoflurane were excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A+B | Active comparator | Drug: Dexamethasone24 mg dexamethasone i.v. perioperatively |
| Placebo | Placebo comparator | Drug: Isotonic salinePlacebo (isotonic saline) i.v. perioperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participation in DEX-2-TKA (NCT03506789)
- General anesthesia
Key exclusion criteria (2 listed)
- Spinal anestehesia
- Use of sevoflurane
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone24 mg intravenous Dexamethasone (6 ml) | Drug | Treatment A+B |
| Isotonic saline6 ml of isotonic saline | Drug | Placebo |
Primary outcome
Intraoperative use of remifentanil
Time frame: During surgery (from surgical incision till last suture)
mg
3 secondary outcomes
Intraoperative use of propofol
Time frame: During surgery (from surgical incision till last suture)
Anesthesia depth
Time frame: During surgery (from surgical incision till last suture)
Time in post-anesthesia care unit (PACU)
Time frame: Time at the PACU (from arrival at the PACU untill transfer to orthopedic ward), approximated 0-4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Derived from this study: PubMed 35908167Gantzel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasper S Gasbjerg, MD principal investigator
Naestved Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Isotonic saline in people with Perioperative Pain, run by Naestved Hospital at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative use of remifentanil (time frame: During surgery (from surgical incision till last suture)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05002361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.