Trial · NCT07449468
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of postoperative delirium | 12 hours after surgery | Incidence of postoperative delirium within 72 hours after surgery, defined as at least one positive Confusion Assessment Method (CAM) assessment (CAM+) at any of the prespecified postoperative time points. CAM will be administered by trained assessors blinded to group allocation. The primary endpoint will be recorded as a binary outcome (delirium: yes/no) |
| Secondary | Incidence of Postoperative Delirium | 24 hours after surgery | Incidence of postoperative delirium within 72 hours after surgery, defined as at least one positive Confusion Assessment Method (CAM) assessment (CAM+) at any of the prespecified postoperative time points. CAM will be administered by trained assessors blinded to group allocation. The primary endpoint will be recorded as a binary outcome (delirium: yes/no) |
| Secondary | Incidence of Postoperative Delirium | 48 hours after surgery | Incidence of postoperative delirium within 72 hours after surgery, defined as at least one positive Confusion Assessment Method (CAM) assessment (CAM+) at any of the prespecified postoperative time points. CAM will be administered by trained assessors blinded to group allocation. The primary endpoint will be recorded as a binary outcome (delirium: yes/no) |
| Secondary | Incidence of Postoperative Delirium | 72 hours after surgery | Incidence of postoperative delirium within 72 hours after surgery, defined as at least one positive Confusion Assessment Method (CAM) assessment (CAM+) at any of the prespecified postoperative time points. CAM will be administered by trained assessors blinded to group allocation. The primary endpoint will be recorded as a binary outcome (delirium: yes/no) |
| Secondary | Cumulative Postoperative Opioid Consumption (MME) | 48 hours after surgery | Total opioid consumption during the first 48 hours after surgery, converted to morphine milligram equivalents (MME). Includes all rescue opioids administered intravenously or orally |
| Secondary | Postoperative Pain Intensity (NRS) | 4 hours after surgery | Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement. |
| Secondary | Postoperative Pain Intensity (NRS) | 8 hours after surgery | Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement. |
| Secondary | Postoperative Pain Intensity (NRS) | 12 hours after surgery | Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement. |
| Secondary | Postoperative Pain Intensity (NRS) | 24 hours after surgery | Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement. |
| Secondary | Postoperative Pain Intensity (NRS) | 48 hours after surgery | Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement. |
| Secondary | Postoperative Pain Intensity (NRS) | 72 hours after surgery | Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement. |
| Secondary | Time to First Rescue Opioid Administration | 48 hours after surgery | Time (in hours) from arrival in the postoperative recovery area to the first administration of rescue opioid analgesia. |
| Secondary | Incidence of Postoperative Nausea and Vomiting (PONV) | 24 hours after surgery | Occurrence of nausea and/or vomiting requiring pharmacological treatment during the early postoperative period. |
| Secondary | Time to First Mobilization | 72 hours after surgery | Time (in hours) from the end of surgery to first assisted mobilization (e.g., standing or ambulation with physiotherapist support). |
| Secondary | Systemic Inflammation Response Index (SIRI) | 12 hours after surgery | Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L. SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response. |
| Secondary | Systemic Inflammation Response Index (SIRI) | 24 hours after surgery | Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L. SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response. |
| Secondary | Systemic Inflammation Response Index (SIRI) | 48 hours after surgery | Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L. SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response. |
| Secondary | Systemic Inflammation Response Index (SIRI) | 72 hours after surgery | Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L. SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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