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

Seoul National University

Status and phase: Completed; Phase 4

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

Treatments: Drug: Sugammadex; Drug: Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT04332627

B-1910/571-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 2 patient groups, including a placebo group

sugammadex

Active Comparator group

Description:

sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg)

Treatment:

Drug: Sugammadex

neostigmine

Placebo Comparator group

Description:

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)

Treatment:

Drug: Neostigmine