Trial · NCT02267538
Dexmedetomidine and Delirium in Patients After Cardiac Surgery
NCT02267538, Phase 4, Completed, Peking University First Hospital; results first posted 2018-02-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dexmedetomidine and Delirium in Patients After Cardiac Surgery. Trials, record NCT02267538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02267538
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dexmedetomidine and Delirium in Patients After Cardiac Surgery
- NCT number
- NCT02267538
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 285 participants, actual
- Lead sponsor
- Peking University First Hospital
- Conditions
- Delirium, C.Surgical Procedure; Cardiac, Postoperative Complications
- Interventions
- dexmedetomidine hydrochloride for injection, 0.9% sodium chloride for injection
- First posted
- 2014-10-17
- Last updated
- 2018-03-05
- Results first posted
- 2018-02-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Postoperative Delirium | During the first five days after surgery | Delirium was assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first five days after surgery. |
| Secondary | Cognitive Function | on the sixth day after surgery, and on the 30th day after surgery | Cognitive function was assessed with the Mini Mental State Examination (MMSE) at baseline (the day before surgery) and on the sixth day after surgery, and with modified telephone interview for cognitive status (m-TICS) on the 30th day after surgery. The introduction of MMSE scale has been explained in the baseline part in the result section. The Telephone Interview for Cognitive Status-modified scale(m-TICS) is one of the most popular telephone interview-based screening instruments for mild cognitive impairment and dementia. It consists 11 items including wordlist memory, orientation, attention, repetition, conceptual knowledge and nonverbal praxis, which score ranges from 0 to 48, with higher scores indicating better cognitive function |
| Secondary | Incidence of Non-delirium Complications After Surgery | Occurrence of non-delirium complications will be monitored until 30 days after surgery. | Non-delirium complications was defined as any conditions other than delirium that occurred during the first 30 days after surgery and required therapeutic intervention.Complications listed here were not considered adverse events in this study. |
| Other | Pain Intensity | During the first five days after surgery | Pain intensity was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = no pain, 10 = the worst possible pain). |
| Other | Subjective Sleep Quality | During the first five days after surgery | Subjective sleep quality was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = best sleep, 10 = the worst possible sleep). |
| Other | Length of Stay in the Intensive Care Unit | From end of surgery until discharge from Intensive Care Unit or 30 days after surgery | Results was presented as median (95% confidence interval). |
| Other | Length of Stay in Hospital After Surgery | From end of surgery until discharge from hospital or 30 days after surgery | Results was presented as median (95% confidence interval). |
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 | Incidence of Postoperative Delirium | During the first five days after surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cognitive Function | on the sixth day after surgery, and on the 30th day after surgery | 5 patients (3 in CTRL group and 2 in DEX group) did not complete the MMSE test on postoperative day 6;17 patients (12 in CTRL group and 5 in DEX group) did not complete the m-TICS test on postoperative day 30 | units on a scale | MEDIAN |
| SECONDARY | Incidence of Non-delirium Complications After Surgery | Occurrence of non-delirium complications will be monitored until 30 days after surgery. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Pain Intensity | During the first five days after surgery | units on a scale | MEDIAN | |
| OTHER_PRE_SPECIFIED | Subjective Sleep Quality | During the first five days after surgery | units on a scale | MEDIAN | |
| OTHER_PRE_SPECIFIED | Length of Stay in the Intensive Care Unit | From end of surgery until discharge from Intensive Care Unit or 30 days after surgery | hours | MEDIAN | |
| OTHER_PRE_SPECIFIED | Length of Stay in Hospital After Surgery | From end of surgery until discharge from hospital or 30 days after surgery | days | MEDIAN |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Postoperative Delirium | DEX Group | 7 | Participants | ||
| Incidence of Postoperative Delirium | CTRL Group | 11 | Participants | ||
| Cognitive Function | DEX Group | MMSE score on postoperative day 6 | 29 | Inter-Quartile Range 27 to 30 | units on a scale |
| Cognitive Function | CTRL Group | MMSE score on postoperative day 6 | 29 | Inter-Quartile Range 27 to 30 | units on a scale |
| Cognitive Function | DEX Group | m-TICS score on postoperative day 30 | 34 | Inter-Quartile Range 32 to 37 | units on a scale |
| Cognitive Function | CTRL Group | m-TICS score on postoperative day 30 | 34 | Inter-Quartile Range 32 to 36 | units on a scale |
| Incidence of Non-delirium Complications After Surgery | DEX Group | Stroke | 3 | Participants | |
| Incidence of Non-delirium Complications After Surgery | CTRL Group | Stroke | 3 | Participants | |
| Incidence of Non-delirium Complications After Surgery | DEX Group | New onset arrythmia | 42 | Participants | |
| Incidence of Non-delirium Complications After Surgery | CTRL Group | New onset arrythmia | 51 | Participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DEX Group | 142 | |
| Overall Study | STARTED | CTRL Group | 143 | |
| Overall Study | COMPLETED | DEX Group | 142 | |
| Overall Study | COMPLETED | CTRL Group | 143 | |
| Overall Study | NOT COMPLETED | DEX Group | 0 | |
| Overall Study | NOT COMPLETED | CTRL Group | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Intraoperative Bradycardia | Cardiac disorders | DEX Group | 21 | 142 | 21 |
| other | Intraoperative Bradycardia | Cardiac disorders | CTRL Group | 14 | 143 | 14 |
| other | Intraoperative Hypotension | Vascular disorders | DEX Group | 10 | 142 | 10 |
| other | Intraoperative Hypotension | Vascular disorders | CTRL Group | 10 | 143 | 10 |
| other | Postoperative Bradycardia | Cardiac disorders | DEX Group | 2 | 142 | 2 |
| other | Postoperative Bradycardia | Cardiac disorders | CTRL Group | 6 | 143 | 6 |
| other | Postoperative Hypotension | Vascular disorders | DEX Group | 5 | 142 | 5 |
| other | Postoperative Hypotension | Vascular disorders | CTRL Group | 10 | 143 | 10 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DEX Group | 2 | 142 |
| Total, all-cause mortality | CTRL Group | 4 | 143 |
| Total, other adverse events | DEX Group | 38 | 142 |
| Total, other adverse events | CTRL Group | 40 | 143 |
| Total, serious adverse events | DEX Group | 0 | 142 |
| Total, serious adverse events | CTRL Group | 0 | 143 |
Source ClinicalTrials.gov
Papers49
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DEX Group vs CTRL Group: Incidence of Postoperative Delirium | Trial comparisons |
| DEX Group vs CTRL Group: deaths from any cause | Trial comparisons |
| DEX Group vs CTRL Group: serious adverse events | 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/NCT02267538
GET https://conductscience.org/api/trials/v1/NCT02267538/results?page=2