{"type":"trials","record":{"id":31423,"source_id":"clinicaltrials-gov","external_id":"NCT06953570","title":"Impact of Frailty on Nalbuphine Dose for Postoperative Analgesia in Elderly Patients Undergoing Laparoscopic GI Surgery","brief_summary":"This study aims to investigate the ED50 and ED95 of nalbuphine combined with dexmedetomidine in patient-controlled intravenous analgesia (PCIA) for elderly patients with different degrees of frailty, as well as their analgesic effects and complications. The results of this study can provide safe and effective dosage guidance for postoperative analgesia in frail patients, help optimize analgesic regimens, reduce the risk of complications, and improve the quality of postoperative recovery.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Yongtao Sun","enrollment":120,"countries":[],"start_date":"2025-10-01","completion_date":"2026-10-10","last_update_date":"2025-05-01","source_url":"https://clinicaltrials.gov/study/NCT06953570","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:21.317971+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years","comparator":null,"organization":"Qianfoshan Hospital","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["Median Effective Dose (ED50) of Nalbuphine Based on Visual Analogue Scale (VAS) for Resting Pain at 24 Hours After Surg…","Dose of Nalbuphine Required to Achieve Resting VAS ≤3 in 95% of Patients Within 24 Hours After Surgery (ED95) — Within…","Resting/Moving VAS (VASR/ VASM) — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36,…","Ramsay Sedation Score (RASS) — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and…","Brinell comfort Scale (BCS) — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and…","Nausea and vomiting (PONV) — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 4…","the effective pressing number of PCIA — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24…","the cumulative pressing number of PCIA — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 2…","sufentanil dose — Exiting PACU immediately","Time to recovery — Exiting PACU immediately","Postoperative Functional Recovery Milestones at Hospital Discharge — At hospital discharge, typically within 3 to 7 day…","Rescue Analgesic Requirements Within 48 Hours After Surgery — At 6, 12, 18, 24, 36, and 48 hours after the end of surge…","Systolic Blood Pressure (SBP) Within 48 Hours After Surgery — At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours…","Number of Participants Experiencing Respiratory Depression (RR <8/min or SpO₂ ≤90%) After Surgery — At PACU discharge (…","Number of Participants Requiring Antipruritic Medication for Persistent Itching After Surgery — At PACU discharge (imme…","Diastolic Blood Pressure (DBP) Within 48 Hours After Surgery — At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hour…","Mean Arterial Pressure (MAP) Within 48 Hours After Surgery — At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours…","Heart Rate (HR) Within 48 Hours After Surgery — At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery","Peripheral Oxygen Saturation (SpO₂) Within 48 Hours After Surgery — At PACU discharge, and at 6, 12, 18, 24, 36, and 48…"],"design_description":null,"source_has_results":false},"controlled_terms":["PCIA","Frailty","Laparoscopic Gastrointestinal Surgery"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct06953570","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-10-01 to 2026-10-10","comparator":null,"confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.513Z","intervention":[],"participants":120,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Median Effective Dose (ED50) of Nalbuphine Based on Visual Analogue Scale (VAS) for Resting Pain at 24 Hours After Surg…","Dose of Nalbuphine Required to Achieve Resting VAS ≤3 in 95% of Patients Within 24 Hours After Surgery (ED95) — Within…","Resting/Moving VAS (VASR/ VASM) — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36,…","Ramsay Sedation Score (RASS) — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and…","Brinell comfort Scale (BCS) — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and…","Nausea and vomiting (PONV) — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 4…","the effective pressing number of PCIA — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24…","the cumulative pressing number of PCIA — At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 2…","sufentanil dose — Exiting PACU immediately","Time to recovery — Exiting PACU immediately","Postoperative Functional Recovery Milestones at Hospital Discharge — At hospital discharge, typically within 3 to 7 day…","Rescue Analgesic Requirements Within 48 Hours After Surgery — At 6, 12, 18, 24, 36, and 48 hours after the end of surge…","Systolic Blood Pressure (SBP) Within 48 Hours After Surgery — At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours…","Number of Participants Experiencing Respiratory Depression (RR <8/min or SpO₂ ≤90%) After Surgery — At PACU discharge (…","Number of Participants Requiring Antipruritic Medication for Persistent Itching After Surgery — At PACU discharge (imme…","Diastolic Blood Pressure (DBP) Within 48 Hours After Surgery — At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hour…","Mean Arterial Pressure (MAP) Within 48 Hours After Surgery — At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours…","Heart Rate (HR) Within 48 Hours After Surgery — At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery","Peripheral Oxygen Saturation (SpO₂) Within 48 Hours After Surgery — At PACU discharge, and at 6, 12, 18, 24, 36, and 48…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/31423","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}