Trial · NCT01214057
Total Intravenous Anesthesia (TIVA) vs. Inhaled Anesthesia for Endoscopic Sinus Surgery.
NCT01214057, Not applicable, Terminated, The University of Texas Health Science Center, Houston; results first posted 2021-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Total Intravenous Anesthesia (TIVA) vs. Inhaled Anesthesia for Endoscopic Sinus Surgery. Trials, record NCT01214057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01214057
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Total Intravenous Anesthesia (TIVA) vs. Inhaled Anesthesia for Endoscopic Sinus Surgery.
- NCT number
- NCT01214057
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 23 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Chronic Rhinosinusitis
- Interventions
- Propofol and Remifentanyl, Sevoflurane and Remifentanyl
- First posted
- 2010-10-04
- Last updated
- 2021-11-01
- Results first posted
- 2021-11-01
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Volume of Blood Loss | during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours) | Blood loss was determined by subtracting the volume of irrigation used intraoperatively from the total volume of fluid in the collection canisters.The Neptune Waste Management System will be used for this purpose. This is a closed suction system that digitally counts the amount of fluid suctioned. |
| Primary | Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised | during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours) | Surgeons rated the surgical field using the Boezaart score (which ranges from 0 to 5, with 5 indicating the most compromised surgical field), and this outcome measure reports the number of participants with a Boezaart score of 5. Boezaart scoring is as follows: 0 (No bleeding, cadaveric conditions); 1 (Slight bleeding, no suctioning required), 2 (Slight bleeding, occasional suctioning required; 3 (Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed); 4 (Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed); 5 (Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible). |
| Primary | Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM) | baseline | Thromboelastography-Platelet Mapping will be performed to assess the effect of the anesthetics on platelet function. Data are reported as Maximum Amplitude (MA) in millimeters (mm). A greater MA value indicates stronger clotting and greater platelet function. |
| Primary | Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM) | During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours) | Thromboelastography-Platelet Mapping will be performed to assess the effect of the anesthetics on platelet function. Data are reported as Maximum Amplitude (MA) in millimeters (mm). A greater MA value indicates stronger clotting and greater platelet function. |
| Primary | Nasal Blood Flow to the Sinonasal Mucosa as Assessed by the Rhinolux System | 0-5 minutes after induction of anesthesia | The Rhinolux system was used to measure nasal blood flow (it assessed changes in the swelling of the nasal mucosa by a tissue light absorption technique similar to that used in pulse oximetry)--more negative optical density unit values indicate greater nasal blood flow and less light. |
| Primary | Nasal Blood Flow to the Sinonasal Mucosa as Assessed by the Rhinolux System | 60-90 minutes after induction of anesthesia | The Rhinolux system was used to measure nasal blood flow (it assessed changes in the swelling of the nasal mucosa by a tissue light absorption technique similar to that used in pulse oximetry)--negative values indicate greater nasal blood flow and less light. |
| Secondary | Duration of Surgery | during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours) | |
| Secondary | Quality of Recovery as Indicated by Pain Rating Using a Visual Analogue Scale (VAS) | During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours) | The VAS ranged from 1-10, with 1 being no pain and 10 being worst pain. |
| Secondary | Quality of Recovery as Indicated by Number of Participants With Nausea | During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours) | |
| Secondary | Quality of Recovery as Indicated by Recovery Time in the PACU | During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Volume of Blood Loss | during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours) | milliliters (mL) | MEAN | |
| PRIMARY | Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised | during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM) | baseline | millimeters (mm) | MEAN | |
| PRIMARY | Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM) | During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours) | millimeters (mm) | MEAN | |
| PRIMARY | Nasal Blood Flow to the Sinonasal Mucosa as Assessed by the Rhinolux System | 0-5 minutes after induction of anesthesia | optical density units | MEAN | |
| PRIMARY | Nasal Blood Flow to the Sinonasal Mucosa as Assessed by the Rhinolux System | 60-90 minutes after induction of anesthesia | optical density units | MEAN | |
| SECONDARY | Duration of Surgery | during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours) | hours | MEAN | |
| SECONDARY | Quality of Recovery as Indicated by Pain Rating Using a Visual Analogue Scale (VAS) | During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours) | These data were not collected for 1 participant in the Inhaled anesthesia arm. | units on a scale | MEAN |
| SECONDARY | Quality of Recovery as Indicated by Number of Participants With Nausea | During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Quality of Recovery as Indicated by Recovery Time in the PACU | During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours) | minutes | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Volume of Blood Loss | Total Intravenous Anesthesia | 152.9 | Standard Deviation 161.3 | milliliters (mL) | |
| Volume of Blood Loss | Inhaled Anesthesia | 355.9 | Standard Deviation 393.4 | milliliters (mL) | |
| Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised | Total Intravenous Anesthesia | 0 | Participants | ||
| Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised | Inhaled Anesthesia | 0 | Participants | ||
| Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM) | Total Intravenous Anesthesia | TEG MA [maximum clot strength] | 71.2 | Standard Deviation 4.80 | millimeters (mm) |
| Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM) | Inhaled Anesthesia | TEG MA [maximum clot strength] | 62.3 | Standard Deviation 11.91 | millimeters (mm) |
| Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM) | Total Intravenous Anesthesia | adenosine diphosphate channel (ADP) MA [maximum contribution of ADP to clot strength] | 58.2 | Standard Deviation 10.84 | millimeters (mm) |
| Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM) | Inhaled Anesthesia | adenosine diphosphate channel (ADP) MA [maximum contribution of ADP to clot strength] | 42.8 | Standard Deviation 12.07 | millimeters (mm) |
| Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM) | Total Intravenous Anesthesia | arachidonic acid channel (AA) MA [maximum contribution of AA to clot strength] | 60.5 | Standard Deviation 15.01 | millimeters (mm) |
| Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM) | Inhaled Anesthesia | arachidonic acid channel (AA) MA [maximum contribution of AA to clot strength] | 50.6 | Standard Deviation 14.64 | millimeters (mm) |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total Intravenous Anesthesia | 12 | |
| Overall Study | STARTED | Inhaled Anesthesia | 11 | |
| Overall Study | COMPLETED | Total Intravenous Anesthesia | 12 | |
| Overall Study | COMPLETED | Inhaled Anesthesia | 11 | |
| Overall Study | NOT COMPLETED | Total Intravenous Anesthesia | 0 | |
| Overall Study | NOT COMPLETED | Inhaled Anesthesia | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total Intravenous Anesthesia | 0 | 12 |
| Total, all-cause mortality | Inhaled Anesthesia | 0 | 11 |
| Total, other adverse events | Total Intravenous Anesthesia | 0 | 12 |
| Total, other adverse events | Inhaled Anesthesia | 0 | 11 |
| Total, serious adverse events | Total Intravenous Anesthesia | 0 | 12 |
| Total, serious adverse events | Inhaled Anesthesia | 0 | 11 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Total Intravenous Anesthesia vs Inhaled Anesthesia: Quality of Recovery as Indicated by Number of Participants With Nausea | Trial comparisons |
| Total Intravenous Anesthesia vs Inhaled Anesthesia: Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised | Trial comparisons |
| Total Intravenous Anesthesia vs Inhaled Anesthesia: deaths from any cause | Trial comparisons |
| Total Intravenous Anesthesia vs Inhaled Anesthesia: 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/NCT01214057
GET https://conductscience.org/api/trials/v1/NCT01214057/results?page=2