Patients Experiences of Early Postoperative Cognition
NCT05361460, Completed, Karolinska Institutet
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Patients Experiences of Early Postoperative Cognition | ClinicalTrials.gov |
| NCT number | NCT05361460 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 40 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Karolinska Institutet | ClinicalTrials.gov |
| Conditions | Postoperative Cognitive Decline, Biomarkers, Postoperative Recovery, Joint Replacement Surgery | ClinicalTrials.gov |
| Interventions | Cognitive decline | ClinicalTrials.gov |
| First posted | 2022-05-04 | ClinicalTrials.gov |
| Last updated | 2023-01-25 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Patients experiences of early postoperative cognitive recovery | 13-16 days after surgery | The opening question t: "How do you yourself experience the time after the operation compared to before? " Probing questions were asked such as "What do you mean?" and "How would you describe that?" The informants will be encouraged to speak freely about the experience. An interview guide will be used to ensure covering issues such as cognition, memory loss, attention, mood and daily activity. | ClinicalTrials.gov |
| Primary | Relatives experiences of patients early postoperative cognitive recovery | 13-16 days after surgery | Opening question : "How would you describe your relative regarding being as they used to be, being themselves, before the operation compared to the time after surgery" Probing questions were asked such as "What do you mean?" and "How would you describe that?" The informants will be encouraged to speak freely about the experience. An interview guide will be used to ensure covering issues such as cognition, memory loss, attention, mood and daily activity. | ClinicalTrials.gov |
| Primary | Cognitive function | 13-16 days after surgery | Cognitive function will be measured preoperatively and on postoperative day 13-16 using the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) neuropsychological test battery The ISPOCD battery assesses cognitive performance using four different tests, providing seven variables for analysis, including Visual Verbal Learning Test, the Concept Shifting Test, the Stroop Colour-Word Test, the Letter-Digit Coding Test and has been validated in the perioperative setting for two decades. The tests will be administered in the same sequence at each test session by the same researcher following a standardized instruction manual in order to ensure as uniform a test situation as possible. The tests will be carried out in quiet rooms and only the patient and a researcher will be present. | ClinicalTrials.gov |
| Primary | Quality of postoperative recovery | 13-16 days after surgery | The patients' quality of recovery will be measured with the Swedish Quality of Recovery (SwQoR), which measure 24 different items related to symptoms/discomfort that appear postoperatively, such as pain, anxiety, sleep difficulties, dizziness, fatigue, returning to work or usual home activities. The items are rated on 11-point numerical scales ranging from 0, "none of the time", to 10, "all of the time". Reliability and validity tests have provided evidence that it is appropriate to use SwQoR in patients undergoing surgery | ClinicalTrials.gov |
| Secondary | Experiences of late postoperative cognitive recovery | 1 year after surgery | One year after the operation, a second interview with the patients will be conducted with a focus on their experiences of the postoperative recovery during the first year. The informants will be encouraged to speak freely about the experience. An interview guide will be used to ensure covering issues such as cognition, memory loss, attention, mood and daily activity. | ClinicalTrials.gov |
| Secondary | C-reactive protein (mg/L) | 13-16 days after surgery | Venous blood samples. Measured preoperatively and postoperative day 1 and on day 13-16 during patient's follow up visit.enous blood samples will be drawn from an intravenous cannula. Blood will be centrifuged and plasma stored at -80 degrees C until further analysed. | ClinicalTrials.gov |
| Secondary | Interleukin-6 (pg/mL) | 13-16 days after surgery | Venous blood samples. Measured preoperatively and postoperative day 1 and on day 13-16 during patient's follow up visit.enous blood samples will be drawn from an intravenous cannula. Blood will be centrifuged and plasma stored at -80 degrees C until further analysed. | ClinicalTrials.gov |
| Secondary | HMGB-1 (μg/mL) | 13-16 days after surgery | Venous blood samples. Measured preoperatively and postoperative day 1 and on day 13-16 during patient's follow up visit.enous blood samples will be drawn from an intravenous cannula. Blood will be centrifuged and plasma stored at -80 degrees C until further analysed. | ClinicalTrials.gov |
| Secondary | Interleukin 1-beta (pg/mL) | 13-16 days after surgery | Venous blood samples. Measured preoperatively and postoperative day 1 and on day 13-16 during patient's follow up visit.enous blood samples will be drawn from an intravenous cannula. Blood will be centrifuged and plasma stored at -80 degrees C until further analysed. | ClinicalTrials.gov |
| Secondary | Interleukin-10 (pg/mL) | 13-16 days after surgery | Venous blood samples. Measured preoperatively and postoperative day 1 and on day 13-16 during patient's follow up visit.enous blood samples will be drawn from an intravenous cannula. Blood will be centrifuged and plasma stored at -80 degrees C until further analysed. | ClinicalTrials.gov |
| Secondary | Fractalkine (pg/mL) | 13-16 days after surgery | Venous blood samples. Measured preoperatively and postoperative day 1 and on day 13-16 during patient's follow up visit.enous blood samples will be drawn from an intravenous cannula. Blood will be centrifuged and plasma stored at -80 degrees C until further analysed. | ClinicalTrials.gov |
| Secondary | Postoperative pain | 13-16 days after surgery | Pain intensity will be measured using a numerical rating scale (NRS) from 0 = no pain to 10 = maximum possible pain. Postoperative pain intensity will be measured postoperative day 1 to 3, the same time of day ±2 hours, and on day 13-16 during patient's follow up visit. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 39880425 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)