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

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04332627
Collaborator
(none)
77
Enrollment
1
Location
2
Arms
2.9
Actual Duration (Months)
26.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
Comparison of Quality of Recovery Score (QoR-15) According to Neuromuscular Blocking Reversal Agent in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine
Actual Study Start Date :
Feb 24, 2020
Actual Primary Completion Date :
May 21, 2020
Actual Study Completion Date :
May 21, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: sugammadex

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

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

Drug: 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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. recovery time [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 [perioperative - until 48hours]

    from entry of PACU to go general ward

  3. 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)

  4. the incidence of administration of postoperative rescue drug [perioperative - until 72hours]

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

  5. hospital stay [preoperative - until discharge (usually 48 hours to 72hours)]

    days of hospital stay

  6. urinary retention [postoperative - until discharge (usually 48 hours to 72hours)]

    residual urine > 300ml diagnosed by bladder ultrasonography

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620

Sponsors and Collaborators

  • Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Jiwon Han, Ms, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
JiWon Han, clinical instructor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT04332627
Other Study ID Numbers:
  • B-1910/571-004
First Posted:
Apr 2, 2020
Last Update Posted:
Dec 24, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neostigmine

Study Results

No Results Posted as of Dec 24, 2020