Comparison of QoR-15 in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine

Phase 4

Completed

• Conditions: Neuromuscular Blockade Reversal Agent; Sugammadex; Quality of Recovery; Laparoscopic Cholecystectomy; Neostigmine
• Interventions: Drug: Sugammadex; Drug: Neostigmine

• Registration Number: NCT04332627
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2020-02-24
• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Primary Completion: 2020-05-21
• Study Completion: 2020-05-21
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugammadex	Sugammadex	sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg)
neostigmine	Neostigmine	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
the incidence of administration of postoperative rescue drug	perioperative - until 72hours	administration of analgesic drug and anti-emetic drug for postoperative management
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
recovery time	perioperative - until 48hours	from injection of sugammadex or neostigmien to extubation and confirm of adequate spontaneous breathing
PACU(post-anesthesia care unit) stay time	perioperative - until 48hours	from entry of PACU to go general ward

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of