Trial · NCT07597486
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 5D-IS score at 24 hours after surgery | 24 hours after surgery | The duration, severity, outcome trend, life impairment and pruritus site (5-D) were used to evaluate the patient's pruritus.Each dimension was scored from 1 to 5, with a total score ranging from 5 to 25. The higher the score, the more severe the itching. |
| Secondary | 5D-IS score at 48 hours,72 hours and the seventh day after surgery | 48 hours,72 hours and the seventh day after surgery | The duration, severity, outcome trend, life impairment and pruritus site (5-D) were used to evaluate the patient's pruritus.Each dimension was scored from 1 to 5, with a total score ranging from 5 to 25. The higher the score, the more severe the itching. |
| Secondary | The incidence of pruritus on the 24 hours after surgery | 24 hours after surgery | The 5D-IS score was completed by the patient 24 hours after the operation. The investigators recorded this score as a statistical indicator. |
| Secondary | NRS pruritus score at 24 hours,48 hours and 72 hours after surgery | 24 hours,48 hours and 72 hours after surgery | The patient evaluated the intensiy of prurtus wth 11 numbers ranging from 0 to 10,and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6 Moderate itching 7-9: Severe itching. 10; Extrermely severe itching. |
| Secondary | Pain Score (NRS) | 1 hours, 24 hours, 48 hours, 72 hours after the surgery | The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0= no pain, 10 = greatest imaginable pain. |
| Secondary | The incidence of postoperative sleep disturbance on the first. second and third postoperative nights | the first,second and third nights after surgery | The patient completed the Sleep Quality Scale (AlS, Athens Insomnia Scale) one day before the surgery, There are a totat of 8 items in the AlS,with the score ranging from 0 to 24. A total score of 6 or above indicates a diagnosis of insomnia. We asked the patients to fill out this questionnaire after the first,second and third postoperative nights to evaluate the changes in sleep quality. The investigators recorded AlS scores as statistical indicators. |
| Secondary | Montreal Cognitive Assessment (MoCA) | 24 hours, 48 hours, 72 hours after the surgery | The Montreal Cognitive Assessment consists of 7 items, which evaluate visuospatial and executive function (5 points), naming (3 points), attention (6 points), language (3 points), abstract thinking (2 points), delayed recall (5 points), and orientation (6 points) respectively. A total score of ≥26 points indicates basically normal cognitive function; a total score of \<25 points suggests cognitive decline. |
| Secondary | Confusion Assessment Method (CAM) | 24 hours, 48 hours, 72 hours after the surgery | Confusion Assessment Method CAM is assessed based on four core features. Feature 1: Acute onset or fluctuating course; Feature 2: Inattention; Feature 3: Disorganized thinking; Feature 4: Altered level of consciousness. The diagnosis of delirium requires a positive result for Feature 1 + a positive result for Feature 2 + a positive result for either Feature 3 or Feature 4. |
| Other | Intraoperative Anesthesia Information | Perioperative period | Duration of anesthesia (minutes) |
| Other | Intraoperative Vital Signs | Perioperative period | Intraoperative average heart rate |
| Other | Adverse Event | 1 hour, 24 hours, 48 hours and 72 hours after surgery | All kinds of adverse events(nausea, vomiting, respiratory depression, headache, dizziness, chills, delayed recovery from anesthesia) occurred in patients were recorded. |
| Other | Intraoperative Anesthesia Information | Perioperative period | Duration of surgery (minutes) |
| Other | Intraoperative Anesthesia Information | Perioperative period | Intraoperative dosage of Sufentanil （μg） |
| Other | Intraoperative Anesthesia Information | Perioperative period | Intraoperative dosage of Remifentani (mg) |
| Other | Intraoperative Vital Signs | Perioperative period | intraoperative average blood oxygen saturation |
| Other | Intraoperative Vital Signs | Perioperative period | Mean Arterial Pressure（MAP） |
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.
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