Trial · NCT01438957
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Who Did Not Require Rescue Administration of Propofol to Achieve and Maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 During the Study Drug Administration. | Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative. | |
| Secondary | Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 15 minutes after the start of study drug, if the OAA/S score is 5. | |
| Secondary | Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 15 minutes after the start of study drug, if the OAA/S score is 5. | |
| Secondary | Time to First Rescue Administration of Propofol | During the study drug infusion period (≥15 minutes [Approximate]) | |
| Secondary | Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration | After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes. | |
| Secondary | Number of Fentanyl Dosing Required During the Study Drug Administration. | During the study drug administration | |
| Secondary | Dosage of Fentanyl Dosing Required During the Study Drug Administration. | During the study drug administration | |
| Secondary | Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion | Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative. | |
| Secondary | Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion | Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative. | |
| Secondary | Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion | Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value becomes ≥8. | |
| Secondary | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level) | Within 24 hours after completion of the study drug administration | VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level. |
| Secondary | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State) | Within 24 hours after completion of the study drug administration | VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level. |
| Secondary | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State) | Within 24 hours after completion of the study drug administration | VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level. |
| Secondary | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation) | Within 24 hours after completion of the study drug administration | VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level. |
| Secondary | Score Evaluation of Satisfaction and Anxiety of the Subject ("I Was Satisfied With This Anesthesia Procedure") | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level. |
| Secondary | Score Evaluation of Satisfaction and Anxiety of the Subject ("I Did Not Feel Pain During the Surgery") | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level. |
| Secondary | Score Evaluation of Satisfaction and Anxiety of the Subject ("If You May Undergo a Similar Surgery, the Same Anesthesia Procedure Will be Requested for the Next Time") | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level. |
| Secondary | Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level Before Surgery") | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level. |
| Secondary | Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level During Surgery") | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level. |
| Secondary | Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level After Surgery") | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT01438957/registered