Trial · NCT01208402
Esmolol for Treatment of Perioperative Tachycardia
NCT01208402, Phase 3, Terminated, Duke University; results first posted 2014-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Esmolol for Treatment of Perioperative Tachycardia. Trials, record NCT01208402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01208402
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Esmolol for Treatment of Perioperative Tachycardia
- NCT number
- NCT01208402
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 76 participants, actual
- Lead sponsor
- Duke University
- Conditions
- High-risk, Non-cardiovascular Surgeries
- Interventions
- Esmolol
- First posted
- 2010-09-24
- Last updated
- 2014-12-12
- Results first posted
- 2014-11-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm | Start of surgery to end of surgery, an average duration of 245 minutes | Duration of intraoperative excursion (ie, time spent) outside Target HR range defined as 60 to 80 bpm during surgery, expressed as percent of case minutes. Vital signs are measured from start of surgery to end of surgery at 5 minute intervals or less. |
| Primary | Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm | End of surgery to 3 hours | Duration of postoperative first three hours spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 3 hours. Vital signs are measured from end of surgery to 3 hours postoperatively at 5 minute intervals for the first hour and every 15 minutes thereafter. |
| Primary | Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm. | Postoperative hours 4-12 | Duration of postoperative hours 4 to 12 spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 9 hours. Vital signs are measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively. |
| Secondary | Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg | Start of surgery to end of surgery, an average duration of 245 minutes | Duration of intraoperative case time patient was not in the target window of SBP \> 95 mmHg, expressed as percent of total case minutes. SBP is measured from start of surgery to end of surgery at 5 minute intervals or less. |
| Secondary | Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg | end of surgery to 3 hours | Duration of postoperative first three hours patient was not in the target window of SBP \> 95 mmHg, expressed as percent of the total 3 hours. SBP is measured from end of surgery to 3 hours postoperatively at 5 minute intervals for first hour and every 15 minutes thereafter. |
| Secondary | Percentage of Postoperative Hours 4 to 12 With Systolic Blood Pressure <95 mmHg | Postoperative hours 4-12 | Duration of postoperative hours 4 to 12 patient was not in the target window of SBP \> 95 mmHg, expressed as percent of the total 9 hours. SBP was measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm | Start of surgery to end of surgery, an average duration of 245 minutes | Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation. | percentage of case minutes | MEDIAN |
| SECONDARY | Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg | Start of surgery to end of surgery, an average duration of 245 minutes | Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation. | percentage of surgery minutes | MEDIAN |
| PRIMARY | Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm | End of surgery to 3 hours | Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only. | percentage of 3 hour interval | MEDIAN |
| SECONDARY | Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg | end of surgery to 3 hours | Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only. | percentage of 3 hour interval | MEDIAN |
| PRIMARY | Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm. | Postoperative hours 4-12 | Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting beta blocker group and in 16 cases in the Esmolol group. | percentage of 8 hour interval | MEDIAN |
| SECONDARY | Percentage of Postoperative Hours 4 to 12 With Systolic Blood Pressure <95 mmHg | Postoperative hours 4-12 | Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting BB group and in 16 cases in the Esmolol group. | percentage of 8 hour interval | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm | Long-Acting Beta Blocker | 39.2 | Inter-Quartile Range 13.6 to 83 | percentage of case minutes | |
| Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm | Esmolol | 37.3 | Inter-Quartile Range 14.4 to 64.6 | percentage of case minutes | |
| Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg | Long-Acting Beta Blocker | 3.3 | Inter-Quartile Range 0 to 9.1 | percentage of surgery minutes | |
| Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg | Esmolol | 3.1 | Inter-Quartile Range 0 to 9.0 | percentage of surgery minutes | |
| Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm | Long-Acting Beta Blocker | 56.5 | Inter-Quartile Range 8.0 to 93.8 | percentage of 3 hour interval | |
| Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm | Esmolol | 39.2 | Inter-Quartile Range 8.3 to 79.6 | percentage of 3 hour interval | |
| Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg | Long-Acting Beta Blocker | 0 | Inter-Quartile Range 0 to 1.4 | percentage of 3 hour interval | |
| Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg | Esmolol | 0 | Inter-Quartile Range 0 to 6.4 | percentage of 3 hour interval | |
| Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm. | Long-Acting Beta Blocker | 39.5 | Inter-Quartile Range 14.2 to 69.8 | percentage of 8 hour interval | |
| Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm. | Esmolol | 37 | Inter-Quartile Range 8.2 to 56.9 | percentage of 8 hour interval |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Long-Acting Beta Blocker | 31 | |
| Overall Study | STARTED | Esmolol | 28 | |
| Overall Study | COMPLETED | Long-Acting Beta Blocker | 30 | |
| Overall Study | COMPLETED | Esmolol | 28 | |
| Overall Study | NOT COMPLETED | Long-Acting Beta Blocker | 1 | |
| Overall Study | NOT COMPLETED | Esmolol | 0 |
Source ClinicalTrials.gov
Adverse events106
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 | HYERTENSION | Cardiac disorders | Long-Acting Beta Blocker | 0 | 31 | |
| other | HYERTENSION | Cardiac disorders | Esmolol | 1 | 28 | |
| other | VOMITING | Gastrointestinal disorders | Long-Acting Beta Blocker | 0 | 31 | |
| other | VOMITING | Gastrointestinal disorders | Esmolol | 1 | 28 | |
| other | CONSTIPATION | Gastrointestinal disorders | Long-Acting Beta Blocker | 0 | 31 | |
| other | CONSTIPATION | Gastrointestinal disorders | Esmolol | 1 | 28 | |
| other | HEARTBURN | Gastrointestinal disorders | Long-Acting Beta Blocker | 0 | 31 | |
| other | HEARTBURN | Gastrointestinal disorders | Esmolol | 1 | 28 | |
| other | HYPOMAGNESEAMIA | Blood and lymphatic system disorders | Long-Acting Beta Blocker | 0 | 31 | |
| other | HYPOMAGNESEAMIA | Blood and lymphatic system disorders | Esmolol | 1 | 28 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Long-Acting Beta Blocker | ||
| Total, all-cause mortality | Esmolol | ||
| Total, other adverse events | Long-Acting Beta Blocker | 16 | 31 |
| Total, other adverse events | Esmolol | 19 | 28 |
| Total, serious adverse events | Long-Acting Beta Blocker | 2 | 31 |
| Total, serious adverse events | Esmolol | 2 | 28 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Long-Acting Beta Blocker vs Esmolol: serious adverse events |
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/NCT01208402
GET https://conductscience.org/api/trials/v1/NCT01208402/events?page=2