Neuromuscular Block Clinical Trial
Single center, prospective, randomized, single blinded, parallel group and controlled, assessor-blinded trial to compare the impact of Deep neuromuscular block and Sugammadex versus Standard of care on Quality of recovery in patient undergo elective laparoscopic cholecystectomy using PQRS at different time-point: 15 minutes (T15), 40 minutes (T40), one(D1) and three(D3) days after surgery
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All adult patients (> 18 years) scheduled for elective Laparoscopic Cholecystectomy with American Society of Anesthesiologist (ASA) class I-III in Hospital of University of Medicine and Pharmacy-Ho Chi Minh City Exclusion Criteria: - Patients with ASA class IV - Age <18 years - Inability to inform consent - History or suspected with neuromuscular disorders - Allergies to rocuronium or sugammadex, anesthetics or narcotics drugs - A history of malignant hyperthermia - A contraindication with neostigmine administration - Pregnancy or breastfeeding - Renal and liver insufficiency are excluded from this study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Vietnam | Operation theathre | Ho Chi Minh |
Lead Sponsor | Collaborator |
---|---|
Ho Chi Minh City University of Medicine and Pharmacy | Merck Sharp & Dohme Corp. |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Surgical condition | The satisfaction of surgeon with surgical condition from Deep Neuromuscular Block against Moderate Neuromuscular block. Surgeons will rate the surgical condition with a five-point surgical condition scale (SRS) ranging from 1= poor condition to 5= optimal surgical condition after the surgery | intraoperation | No |
Other | Time to discharge readiness | Time to discharge readiness from the post-anesthesia care unit (PACU) using Post Anesthesia Discharge Score System (PADSS) | Every 20 min from the start of admission to the post-anesthesia care unit (PACU), up to 2 hours | No |
Other | Duration of operation | Duration of surgery: from successful abdominal access with trocars to the skin closure Duration from reversal to extubation (TOF>0.9) | intraoperation | No |
Primary | Quality of recovery | The primary outcome is to access the differences of Quality of recovery in the overall recovery of the Post-operative Quality Recovery Scale (PQRS) instrument at 40 minutes (T40) after the end of surgery between Deep NMB (reversed with Sugammadex) and Standard of care in patients who undergo Laparoscopic Cholecystectomy. PQRS includes six domains of recovery: physiologic, nociceptive, emotive, activities of daily living, cognitive, and overall patient perspective. There is a series of questions in each domain. The Postoperative Quality Recovery Scale (PQRS) will be performed and recorded face-to-face by anesthesiologists in hospital and by telephone after discharge. The PQRS is completed prior to surgery to provide baseline values. Recovery is defined as returning to baseline values or better in each of the questions or assessments. |
40 minutes (T40) after the end of surgery | No |
Secondary | Quality of recovery | The differences of Quality of recovery in the overall recovery of the PQRS instrument at 15 minutes (T15), and first day, 3 days after the end of surgery The differences between each domain of PQRS instrument from 2 groups. |
15 minutes (T15), and first day, 3 days after the end of surgery | No |
Secondary | Shoulder tip pain | using a 100 mm visual analogue scale (VAS) (0 indicating no pain and 100 worst imaginable pain) | first hour, 6 hours and 24 hours after surgery | No |
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