Trial · NCT01973452
Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
NCT01973452, Phase 3, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2024-02-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery. Trials, record NCT01973452. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01973452
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
- NCT number
- NCT01973452
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 333 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Pain
- Interventions
- Dexmedetomidine, Placebo
- First posted
- 2013-10-31
- Last updated
- 2024-02-20
- Results first posted
- 2024-02-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Opioid Administered | up to 4 hours | total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours |
| Secondary | Improves Analgesia | up to 24 hours | as measured by change in Pain Numerical Rating Scale (NRS) preoperatively to postoperatively at rest and with activity (such as coughing). In the Pain Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible' |
| Secondary | Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | up to 24 hours | as measured by incidence of recorded nausea or the use of antiemetics and RASS sedation scores, respectively. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Opioid Administered | up to 4 hours | Morphine Milligram Equivalents | MEDIAN | |
| SECONDARY | Improves Analgesia | up to 24 hours | score on a scale | MEDIAN | |
| SECONDARY | Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | up to 24 hours | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Opioid Administered | Dexmedetomidine | 4.0 | Full Range 0.0 to 12.0 | Morphine Milligram Equivalents | |
| Total Opioid Administered | Placebo | 6.0 | Full Range 0.0 to 14.0 | Morphine Milligram Equivalents | |
| Improves Analgesia | Dexmedetomidine | 4.0 | Full Range 2.7 to 5.0 | score on a scale | |
| Improves Analgesia | Placebo | 4.0 | Full Range 2.8 to 5.0 | score on a scale | |
| Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | Dexmedetomidine | Participants with recorded nausea | 113 | Participants | |
| Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | Placebo | Participants with recorded nausea | 110 | Participants | |
| Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | Dexmedetomidine | Participants without recorded nausea | 35 | Participants | |
| Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | Placebo | Participants without recorded nausea | 42 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexmedetomidine | 165 | |
| Overall Study | STARTED | Placebo | 166 | |
| Overall Study | COMPLETED | Dexmedetomidine | 148 | |
| Overall Study | COMPLETED | Placebo | 152 | |
| Overall Study | NOT COMPLETED | Dexmedetomidine | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events18
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 |
|---|---|---|---|---|---|---|
| serious | Fever | General disorders | Dexmedetomidine | 2 | 148 | |
| serious | Fever | General disorders | Placebo | 0 | 152 | |
| serious | Lung infection | Infections and infestations | Dexmedetomidine | 0 | 148 | |
| serious | Lung infection | Infections and infestations | Placebo | 2 | 152 | |
| serious | Intraoperative splenic injury | Injury, poisoning and procedural complications | Dexmedetomidine | 0 | 148 | |
| serious | Intraoperative splenic injury | Injury, poisoning and procedural complications | Placebo | 1 | 152 | |
| serious | Postoperative hemorrhage | Injury, poisoning and procedural complications | Dexmedetomidine | 0 | 148 | |
| serious | Postoperative hemorrhage | Injury, poisoning and procedural complications | Placebo | 1 | 152 | |
| serious | Delirium | Psychiatric disorders | Dexmedetomidine | 0 | 148 | |
| serious | Delirium | Psychiatric disorders | Placebo | 1 | 152 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexmedetomidine | 33 | 148 |
| Total, all-cause mortality | Placebo | 37 | 152 |
| Total, other adverse events | Dexmedetomidine | 0 | 148 |
| Total, other adverse events | Placebo | 0 | 152 |
| Total, serious adverse events | Dexmedetomidine | 5 | 148 |
| Total, serious adverse events | Placebo | 8 | 152 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dexmedetomidine vs Placebo: deaths from any cause | Trial comparisons |
| Dexmedetomidine vs Placebo: 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/NCT01973452
GET https://conductscience.org/api/trials/v1/NCT01973452/registered