Clinical trial NCT04332627: Comparison of QoR-15 in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine
Official title: Comparison of Quality of Recovery Score (QoR-15) According to Neuromuscular Blocking Reversal Agent in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade Reversal Agent
Sugammadex
Neostigmine
Quality of Recovery
Laparoscopic Cholecystectomy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 77
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Recovery(QoR)-15 questionnaire score
timeFrame: preoperative 1 days to postoperative 2 days
Secondary outcomes:
measure: recovery time
timeFrame: perioperative - until 48hours
measure: PACU(post-anesthesia care unit) stay time
timeFrame: perioperative - until 48hours
measure: postoperative pain score
timeFrame: at postoperative 30minutes, 6hours, 24hours
measure: the incidence of administration of postoperative rescue drug
timeFrame: perioperative - until 72hours
measure: hospital stay
timeFrame: preoperative - until discharge (usually 48 hours to 72hours)
measure: urinary retention
timeFrame: postoperative - until discharge (usually 48 hours to 72hours)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jiwon Han, Ms
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.