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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sugammadex | Active Comparator | sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg) |
|
| neostigmine | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery(QoR)-15 questionnaire score | 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) | preoperative 1 days to postoperative 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| recovery time | from injection of sugammadex or neostigmien to extubation and confirm of adequate spontaneous breathing | perioperative - until 48hours |
| PACU(post-anesthesia care unit) stay time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiwon Han, Ms | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23411725 | Background | Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b. | |
| 28806470 | Background | Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763. |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Neostigmine | Drug | 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) |
|
from entry of PACU to go general ward
| perioperative - until 48hours |
| postoperative pain score | postoperative pain score measured by 11-point NRS(numerical rating scale) score (minimum : 0, maximum : 11, the lower the score, the lesser pain) | at postoperative 30minutes, 6hours, 24hours |
| the incidence of administration of postoperative rescue drug | administration of analgesic drug and anti-emetic drug for postoperative management | perioperative - until 72hours |
| hospital stay | days of hospital stay | preoperative - until discharge (usually 48 hours to 72hours) |
| urinary retention | residual urine > 300ml diagnosed by bladder ultrasonography | postoperative - until discharge (usually 48 hours to 72hours) |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |