Deep Neuromuscular Block and Sugammadex Versus Standard of Care on Quality of Recovery in Patient Undergo Elective Laparoscopic Cholecystectomy

Neuromuscular Block Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02648503
• Other study ID #: 8616-138
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 7, 2015
• Last updated: January 6, 2016
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Ho Chi Minh City University of Medicine and Pharmacy
• Contact: Vu TN Phan, PhD. MD
• Phone: +84-908883458
• Email: vuphan682003[@]yahoo.com
• Is FDA regulated: No
• Health authority: Vietnam: Ho Chi Minh City Health Service
• Study type: Interventional

Clinical Trial Summary

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

Description:

• In the current study, the investigators investigate the effect of a deep NMB (TOF 0, PTC 1-2) with sugammadex against a moderate block (TOF 1-2) 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.

• Based on a previous study comparing the Quality of recovery using PQRS between Neostigmine and Sugammadex, P. Amorim at al. showed that the percentage of patients fully awake at 40 min was 96.2% in the sugammadex group and 72.9% in the neostigmine group; the investigators expected the percentage of patient recovery at T40 will be 90% in group D (sugammadex) and 70% in group M (neostigmine)12. Recovery defined as return to the value of PQRS measured prior to surgery or higher. Using the formula for the sample size with α=0.05, Power: 80%, the sample size required per group is 60.

• Eligible patients will be randomly allocated into two groups using a computer-generated randomization before patients arrive to the operating room: Group D with deep, continuous neuromuscular blockade and Group M with moderate neuromuscular blockade.

• All information about group allocation, doses of rocuronium and sugammadex and neuromuscular data are recorded on a separate form and placed in a sealed opaque envelope when the patient is leaving the operating room. This will keep the personnel in the post-anesthesia care unit and the investigator collecting post-operative data blinded to group allocation.

• The investigators use acceleromyography (TOF-Watch SX) to monitor the level of neuromuscular blockage at the adductor pollicis muscle

• Involuntary movement will be recorded by anesthesia during surgery.

• Surgical condition will be rated by surgeons after surgery using five-point surgical condition scale (SRS)

• Hemodynamic changes using the noninvasive Nihon Konden (Nihon Konden, Japan), duration of surgery, drug dosages used during anesthesia, and duration from reversal to extubation, BIS, and ventilatory variables (tidal volume, respiratory rate, breathing pressure).

• Intra-abdominal pressure will be measured every 15 minutes from the peritoneal CO2 insufflation device. Pneumoperitoneum is obtained with insufflation of CO2 at 8 mmHg after the introduction of the trocars. In case of inadequate surgical conditions:

• Increase of pre-set intra-abdominal pressure to 12-14 mmHg.

• If still not adequate, patients will be given a bolus of rocuronium 0.075-0.15 mg/kg

• If still not adequate, the surgeon will decide according to usual clinical practice.

• The intervention will be recorded by anesthesiologist and surgical condition rate will be measured at the time of surgery when they get worse.

• 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 domain2. PQRS data will be presented as percentage of patients that recovered for measurements taken at T15, T40, D1, and D3.

• Data of all patients that completed the baseline evaluation and T15 and T40 of the follow-up evaluations will be included in primary efficacy analysis.

• Continuous data will be presented as mean and standard deviation (SD) or median and range (minimum, maximum) and interquartile range (IQR, 25th 75th percentile). Categorical data will be presented as frequencies and percentages.

• The physiological domain data will be presented as mean and SD. The nociceptive domain data will be presented as mean with the 95% confidence intervals (CI).

• Categorical variables will be compared with the the Fisher exact test.

• For the comparison of continuous data, the Student's t test will be used. If there is substantial evidence of departures from normality, then the Mann-Whitney U-test will be performed as a sensitivity analysis.

• Data will be analyzed with the Statistical Package for the Social Sciences statistical software program. Statistical significance was set at P less than 0.05.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Block

Intervention

Drug:
• Deep neuromuscular block
Using rocuronium and reversal with sugammadex
• Moderate neuromuscular block
Using rocuronium and reversal with neostigmine (1 to 2 mg) and atropine (0.5 to 1 mg)

Locations

Country	Name	City	State
Vietnam	Operation theathre	Ho Chi Minh

Sponsors (2)

Lead Sponsor	Collaborator
Ho Chi Minh City University of Medicine and Pharmacy	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Vietnam, 

Outcome

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