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Comparison · NCT01214057-a72ef50f

Total Intravenous Anesthesia vs Inhaled Anesthesia: Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Total Intravenous Anesthesia vs Inhaled Anesthesia: Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised. Trial comparisons, record NCT01214057-a72ef50f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01214057-a72ef50f

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 100.00000000000000002780.242wilson
Risk in group 2000.259wilson
Risk difference, group 1 minus group 20-0.2590.242newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Total Intravenous Anesthesia
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl~Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
012OG000
Group 2Inhaled Anesthesia
Inhaled anesthesia with sevoflurane and remifentanyl.~Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
011OG001

Outcome

Type
PRIMARY
Title
Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised
Description
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).
Time frame
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)
Population

Source ClinicalTrials.gov

Trial

Title
Total Intravenous Anesthesia (TIVA) vs. Inhaled Anesthesia for Endoscopic Sinus Surgery.
NCT number
NCT01214057
Phases
NA
Conditions
Chronic Rhinosinusitis
Interventions
Propofol and Remifentanyl, Sevoflurane and Remifentanyl
Lead sponsor
The University of Texas Health Science Center, Houston
Results first posted
2021-11-01

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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