Trial · NCT03246724
Oral Versus Intravenous Sedation for Ocular Procedures
NCT03246724, Phase 4, Completed, Boston Medical Center; results first posted 2020-08-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Versus Intravenous Sedation for Ocular Procedures. Trials, record NCT03246724. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03246724
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Versus Intravenous Sedation for Ocular Procedures
- NCT number
- NCT03246724
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 327 participants, actual
- Lead sponsor
- Boston Medical Center
- Conditions
- Surgery, Sedation
- Interventions
- Triazolam, Midazolam, Microcrystalline Cellulose, Sodium chloride 0.9%
- First posted
- 2017-08-11
- Last updated
- 2020-08-19
- Results first posted
- 2020-08-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Satisfaction | The patient satisfaction survey was administered up to two days after surgery. | Patient satisfaction will be determined by completion of a 12 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per patient. Higher mean scores are associated with higher levels of satisfaction. |
| Secondary | Surgeon Satisfaction | The surgeon satisfaction survey will be administered immediately after the completion of the surgery. . | Surgeon satisfaction will be determined by completion of a 5 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per surgeon Higher mean scores are associated with higher levels of satisfaction. |
| Secondary | Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction | The anesthesiologist/CRNA satisfaction survey will be administered immediately after the completion of the surgical case. | Anesthesiologist/CRNA satisfaction will be determined by completion of a 5 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per anesthesiologist/CRNA. Higher mean scores are associated with higher levels of satisfaction. |
| Other | Number of Participants Requiring Additional Anesthesia Intervention | Information regarding additional anesthesia intervention will be collected within 2 days of completion of the subjects surgical procedure. | The number of subjects in each arm that received additional anesthetic agents during the operative procedure after the initial sedation. |
| Other | Surgical Complication Rates | Information regarding surgical complications will be collected within 2 days of completion of the subjects surgical procedure. | The number of subjects in each arm that experienced a complication during the operative procedure after the initial sedation. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient Satisfaction | The patient satisfaction survey was administered up to two days after surgery. | score on a scale | MEAN | |
| SECONDARY | Surgeon Satisfaction | The surgeon satisfaction survey will be administered immediately after the completion of the surgery. . | score on a scale | MEAN | |
| SECONDARY | Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction | The anesthesiologist/CRNA satisfaction survey will be administered immediately after the completion of the surgical case. | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Number of Participants Requiring Additional Anesthesia Intervention | Information regarding additional anesthesia intervention will be collected within 2 days of completion of the subjects surgical procedure. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Surgical Complication Rates | Information regarding surgical complications will be collected within 2 days of completion of the subjects surgical procedure. | Data was not available for one participant in the cornea arm. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Satisfaction | Cataract Procedures | 5.37 | Standard Deviation 0.57 | score on a scale | |
| Patient Satisfaction | Retina Procedures | 5.23 | Standard Deviation 0.72 | score on a scale | |
| Patient Satisfaction | Cornea Procedures | 5.37 | Standard Deviation 0.68 | score on a scale | |
| Patient Satisfaction | Glaucoma Procedures | 5.05 | Standard Deviation 0.87 | score on a scale | |
| Surgeon Satisfaction | Cataract Procedures | 5.28 | Standard Deviation 0.97 | score on a scale | |
| Surgeon Satisfaction | Retina Procedures | 5.57 | Standard Deviation 0.84 | score on a scale | |
| Surgeon Satisfaction | Cornea Procedures | 5.34 | Standard Deviation 0.95 | score on a scale | |
| Surgeon Satisfaction | Glaucoma Procedures | 4.6 | Standard Deviation 1.37 | score on a scale | |
| Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction | Cataract Procedures | 5.16 | Standard Deviation 0.96 | score on a scale | |
| Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction | Retina Procedures | 5.14 | Standard Deviation 0.94 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cataract Procedures | 99 | |
| Overall Study | STARTED | Retina Procedures | 91 | |
| Overall Study | STARTED | Cornea Procedures | 85 | |
| Overall Study | STARTED | Glaucoma Procedures | 52 | |
| Overall Study | COMPLETED | Cataract Procedures | 85 | |
| Overall Study | COMPLETED | Retina Procedures | 84 | |
| Overall Study | COMPLETED | Cornea Procedures | 70 | |
| Overall Study | COMPLETED | Glaucoma Procedures | 44 | |
| Overall Study | NOT COMPLETED | Cataract Procedures | 14 | |
| Overall Study | NOT COMPLETED | Retina Procedures | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse 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 | Pain During Surgery | Surgical and medical procedures | Cataract Procedures | 1 | 85 | 1 |
| other | Pain During Surgery | Surgical and medical procedures | Retina Procedures | 15 | 84 | 15 |
| other | Pain During Surgery | Surgical and medical procedures | Cornea Procedures | 5 | 70 | 5 |
| other | Pain During Surgery | Surgical and medical procedures | Glaucoma Procedures | 3 | 44 | 3 |
| other | Nausea & Vomiting Post-surgery | Surgical and medical procedures | Cataract Procedures | 2 | 85 | 2 |
| other | Nausea & Vomiting Post-surgery | Surgical and medical procedures | Retina Procedures | 7 | 84 | 7 |
| other | Nausea & Vomiting Post-surgery | Surgical and medical procedures | Cornea Procedures | 1 | 70 | 1 |
| other | Nausea & Vomiting Post-surgery | Surgical and medical procedures | Glaucoma Procedures | 1 | 44 | 1 |
| other | Headache & Dizziness | Surgical and medical procedures | Cataract Procedures | 3 | 85 | 3 |
| other | Headache & Dizziness | Surgical and medical procedures | Retina Procedures | 2 | 84 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cataract Procedures | 0 | 85 |
| Total, all-cause mortality | Retina Procedures | 0 | 84 |
| Total, all-cause mortality | Cornea Procedures | 0 | 70 |
| Total, all-cause mortality | Glaucoma Procedures | 0 | 44 |
| Total, other adverse events | Cataract Procedures | 8 | 85 |
| Total, other adverse events | Retina Procedures | 17 | 84 |
| Total, other adverse events | Cornea Procedures | 6 | 70 |
| Total, other adverse events | Glaucoma Procedures | 6 | 44 |
| Total, serious adverse events | Cataract Procedures | 1 | 85 |
| Total, serious adverse events | Retina Procedures | 0 | 84 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03246724
GET https://conductscience.org/api/trials/v1/NCT03246724/events?page=2