Laparoscopic Cholecystectomy, Neostigmine, Neuromuscular Blockade Reversal Agent, Quality of Recovery, Sugammadex
Conditions
Brief summary
The quality of recovery in patients who were reversed neuromuscular blockade by using Sumamadex and Neostigmine in laparoscopic cholecystectomy was compared through the QoR(Quality of Recovery)-15 questionnaire.
Detailed description
Quality of Recovery questionnaire includes five details (Emotional status, Physical comfort, Physiological support, Physical independece, Pain), and is a proven method of reliability, consistency and validity for evaluating recovery from surgery and anesthesia. After laparoscopic cholecystectomy, patients experience various discomforts such as pain, nausea, vomiting, and placebo due to general anesthesia. Neostigmine has side effects such as crampy abdominal pain, nausea and vomiting. In addition, residual neuromuscular blockade was higher in neostigmine compared with sugammadex. Although sugammadex expected to improve patient's recovery, it is still controversial that sugammadex contributes to clinically meaningfull difference compared with neostigmine. Therefore, the aim of our study is comparison of quality of recovery through QoR-15 questionnaire in patients who were reversed neuromuscular blockade by using sugammadex and neostigmine in laparoscopic cholecystectomy.
Interventions
DRUGSugammadex
sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg)
DRUGNeostigmine
with glycopyrrolate 0.4mg, neostigmine 0.02mg/kg or 0.04mg/kg or 0.05mg/kg according to Train-of-four count (TOF 0 : wait until TOF 2, TOF2-3: 0.05mg/kg, TOF4: 0.04mg/kg)
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patients who underwent laparoscopic cholecystectomy aged 20-70
Exclusion criteria
* neuromuscular disease * allergy to rocuronium, sugammadex, neostigmine * cognitive impairment ( disable to answer the questionnaire ) * refuse to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery(QoR)-15 questionnaire score | preoperative 1 days to postoperative 2 days | the difference of Quality of Recovery(QoR)-15 score between preoperative and postoperative 1 and 2 days (minimum value : 0, maximum value : 150, the higher the score, the better the result) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PACU(post-anesthesia care unit) stay time | perioperative - until 48hours | from entry of PACU to go general ward |
| postoperative pain score | at postoperative 30minutes, 6hours, 24hours | postoperative pain score measured by 11-point NRS(numerical rating scale) score (minimum : 0, maximum : 11, the lower the score, the lesser pain) |
| recovery time | perioperative - until 48hours | from injection of sugammadex or neostigmien to extubation and confirm of adequate spontaneous breathing |
| hospital stay | preoperative - until discharge (usually 48 hours to 72hours) | days of hospital stay |
| urinary retention | postoperative - until discharge (usually 48 hours to 72hours) | residual urine \> 300ml diagnosed by bladder ultrasonography |
| the incidence of administration of postoperative rescue drug | perioperative - until 72hours | administration of analgesic drug and anti-emetic drug for postoperative management |
Countries
South Korea
Outcome results
None listed