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