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Completed

NCT Number: NCT04332627

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

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.

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Key information

Conditions

Neuromuscular Blockade Reversal Agent Laparoscopic Cholecystectomy Neostigmine Quality of Recovery Sugammadex

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

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

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)

Primary outcomes

  1. Quality of Recovery(QoR)-15 questionnaire score

    Time frame: 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 outcomes

  1. recovery time

    Time frame: perioperative - until 48hours

    from injection of sugammadex or neostigmien to extubation and confirm of adequate spontaneous breathing

  2. PACU(post-anesthesia care unit) stay time

    Time frame: perioperative - until 48hours

    from entry of PACU to go general ward

  3. postoperative pain score

    Time frame: 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)

  4. the incidence of administration of postoperative rescue drug

    Time frame: perioperative - until 72hours

    administration of analgesic drug and anti-emetic drug for postoperative management

  5. hospital stay

    Time frame: preoperative - until discharge (usually 48 hours to 72hours)

    days of hospital stay

  6. urinary retention

    Time frame: postoperative - until discharge (usually 48 hours to 72hours)

    residual urine > 300ml diagnosed by bladder ultrasonography

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Comparison of Quality of Recovery Score (QoR-15) According to Neuromuscular Blocking Reversal Agent in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2020
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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