Trial · NCT01690988
The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial
NCT01690988, Phase 3, Completed, Washington University School of Medicine; results first posted 2018-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial. Trials, record NCT01690988. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01690988
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial
- NCT number
- NCT01690988
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 746 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Delirium
- Interventions
- Ketamine (0.5 mg/kg), Normal Saline (placebo), Ketamine (1 mg/kg)
- First posted
- 2012-09-24
- Last updated
- 2018-06-06
- Results first posted
- 2018-05-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 | Delirium incidence on postoperative days 1-3, calculated by any positive CAM on any day for all patients | According to Confusion Assessment Method or Confusion Assessment Method for Intensive Care Unit criteria the number of patients that had any positive CAM on any day for all patients. The main effect evaluated will be to determine whether ketamine decreases delirium, table 3 of the protocol provides a useful guide for the potential findings of the current study with their implications. To further clarify, delirium will be assessed on the day of surgery, when possible and on the subsequent three days POD 1-3, as long as as patients remain in the hospital and are assessable (i.e., not sedated to a RASS \<-3). The assessments on POD 1-3 will be done twice daily, once in the morning and once in the afternoon. The primary outcome of the study includes only the delirium incidence on POD 1-3. The primary comparison will be between the combined ketamine groups and the placebo group. |
| Secondary | Daily Maximum Pain Recorded | Postoperative days 1-3, two assessment daily (morning and afternoon), with at least six hours between assessments | Assessed by observer-based Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) with subsequent administration of patient-reported Visual Analog Scale The behavioral pain scale has three domains and ranges from 3 to 15. The visual analog scale is a continuous scale from 0 to 100 mm. Daily Maximum Pain accounted for pain level in the AM or PM for both the VAS and the BPS/BPS-NI a higher value means a worse outcome. |
| Secondary | Median Opioid Consumption | Postoperative days 0-3 | Assessed from patients' medical charts. All morphine equivalent drugs consumed by patients perioperatively Opioid Drugs included: \* Postoperatively while still in hospital, the list of pain medication used included Morphine, Hydromorphone, Meperidine, Nalbuphine, Oxycodone,Oxymorphone, Tramadol, bupivacaine, (Codeine, Fentanyl, Naloxone) Total Opiates (Morphine Equivalent) in milligrams The median(IQR) opioid consumption was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg) |
| Secondary | Number of Patients With Postoperative Nausea and Vomiting | Postoperative days 1-3 | Assessed from patient-reported postoperative nausea and vomiting section of Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) Patients where asked whether they "currently have nausea/vomiting" AM \& PM the response choices: None, Mild, Moderate, Severe Incidence of nausea\\vomiting accounted for any positive reporting(Mild, moderate, or sever) Daily incidence accounted for any positive incidence AM/PM in each POD Any POD nausea/vomiting reports the incidence across day 1-3 The incidence of nausea and or vomiting was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg) for POD 1-3 and overall. |
| Secondary | ICU and/or Hospital Length of Stay | Postoperative period | Assessed from patients' medical charts |
| Secondary | Adverse Outcomes (Number of Patients With Hallucinations) | Postoperative days 1-3 | Assessed via Confusion Assessment Method or Confusion Assessment Method for Intensive Care Unit |
| Secondary | Adverse Outcomes (Number of Patients With Nightmares) | Postoperative days 1-3 | Assessed via Confusion Assessment Method or Confusion Assessment Method for Intensive care Unit |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 | Delirium incidence on postoperative days 1-3, calculated by any positive CAM on any day for all patients | Of all 672 participants, data were analyzed AM and PM and post operative day 1 through day 3 for screened participants with a CAM. The overall incidence of delirium were compared, Ketamine 0.5 mg/kg and 1 mg/kg groups were combined as per-specified in the study protocol. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Daily Maximum Pain Recorded | Postoperative days 1-3, two assessment daily (morning and afternoon), with at least six hours between assessments | participants | MEDIAN | |
| SECONDARY | Median Opioid Consumption | Postoperative days 0-3 | mg | MEDIAN | |
| SECONDARY | Number of Patients With Postoperative Nausea and Vomiting | Postoperative days 1-3 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | ICU and/or Hospital Length of Stay | Postoperative period | Outcome measure data were not collected. | ||
| SECONDARY | Adverse Outcomes (Number of Patients With Hallucinations) | Postoperative days 1-3 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Outcomes (Number of Patients With Nightmares) | Postoperative days 1-3 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 | Ketamine (0.5 mg/kg and 1 mg/kg) | 85 | Participants | ||
| Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 | Normal Saline (Placebo) | 43 | Participants | ||
| Daily Maximum Pain Recorded | Ketamine (0.5 mg/kg ) | VAS day 1 | 70 | Inter-Quartile Range 40 to 87 | participants |
| Daily Maximum Pain Recorded | Normal Saline (Placebo) | VAS day 1 | 63.5 | Inter-Quartile Range 43 to 82 | participants |
| Daily Maximum Pain Recorded | Ketamine (1 mg/kg) | VAS day 1 | 68 | Inter-Quartile Range 37.5 to 90 | participants |
| Daily Maximum Pain Recorded | Ketamine (0.5 mg/kg ) | VAS day 2 | 56 | Inter-Quartile Range 30 to 80 | participants |
| Daily Maximum Pain Recorded | Normal Saline (Placebo) | VAS day 2 | 59 | Inter-Quartile Range 31 to 80 | participants |
| Daily Maximum Pain Recorded | Ketamine (1 mg/kg) | VAS day 2 | 57.5 | Inter-Quartile Range 27 to 81 | participants |
| Daily Maximum Pain Recorded | Ketamine (0.5 mg/kg ) | VAS day 3 | 46 | Inter-Quartile Range 22.5 to 75 | participants |
| Daily Maximum Pain Recorded | Normal Saline (Placebo) | VAS day 3 | 52.5 | Inter-Quartile Range 25.5 to 75 | participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ketamine (0.5 mg/kg) | 227 | |
| Overall Study | STARTED | Normal Saline (Placebo) | 222 | |
| Overall Study | STARTED | Ketamine (1 mg/kg) | 223 | |
| Overall Study | COMPLETED | Ketamine (0.5 mg/kg) | 221 | |
| Overall Study | COMPLETED | Normal Saline (Placebo) | 217 | |
| Overall Study | COMPLETED | Ketamine (1 mg/kg) | 216 | |
| Overall Study | NOT COMPLETED | Ketamine (0.5 mg/kg) | 6 | |
| Overall Study | NOT COMPLETED | Normal Saline (Placebo) | 5 | |
| Overall Study | NOT COMPLETED | Ketamine (1 mg/kg) | 7 |
Source ClinicalTrials.gov
Adverse events24
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 |
|---|---|---|---|---|---|---|
| other | Atrial Fibriliation | Nervous system disorders | Ketamine (0.5 mg/kg) | 21 | 227 | 21 |
| other | Atrial Fibriliation | Nervous system disorders | Normal Saline (Placebo) | 19 | 222 | 19 |
| other | Atrial Fibriliation | Nervous system disorders | Ketamine (1 mg/kg) | 15 | 223 | 15 |
| other | Anaemia/Bleeding | Blood and lymphatic system disorders | Ketamine (0.5 mg/kg) | 19 | 227 | 19 |
| other | Anaemia/Bleeding | Blood and lymphatic system disorders | Normal Saline (Placebo) | 13 | 222 | 13 |
| other | Anaemia/Bleeding | Blood and lymphatic system disorders | Ketamine (1 mg/kg) | 20 | 223 | 20 |
| other | Infection | Infections and infestations | Ketamine (0.5 mg/kg) | 16 | 227 | 16 |
| other | Infection | Infections and infestations | Normal Saline (Placebo) | 18 | 222 | 18 |
| other | Infection | Infections and infestations | Ketamine (1 mg/kg) | 15 | 223 | 15 |
| other | Renal | Renal and urinary disorders | Ketamine (0.5 mg/kg) | 13 | 227 | 13 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketamine (0.5 mg/kg) | 0 | 227 |
| Total, all-cause mortality | Normal Saline (Placebo) | 2 | 220 |
| Total, all-cause mortality | Ketamine (1 mg/kg) | 0 | 223 |
| Total, other adverse events | Ketamine (0.5 mg/kg) | 90 | 227 |
| Total, other adverse events | Normal Saline (Placebo) | 82 | 222 |
| Total, other adverse events | Ketamine (1 mg/kg) | 86 | 223 |
| Total, serious adverse events | Ketamine (0.5 mg/kg) | 0 | 227 |
| Total, serious adverse events | Normal Saline (Placebo) | 0 | 222 |
| Total, serious adverse events | Ketamine (1 mg/kg) | 0 | 223 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ketamine (0.5 mg/kg and 1 mg/kg) vs Normal Saline (Placebo): Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01690988
GET https://conductscience.org/api/trials/v1/NCT01690988/results?page=2