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

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332627
• Other study ID #: B-1910/571-004
• Status: Completed
• Phase: Phase 4
• Start date: February 24, 2020
• Est. completion date: May 21, 2020

Study information

• Verified date: December 2020
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 21, 2020
• Est. primary completion date: May 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy
• Neostigmine
• Neuromuscular Blockade Reversal Agent
• Quality of Recovery
• Sugammadex

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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:CD012763. doi: 10.1002/14651858.CD012763. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery(QoR)-15 questionnaire score	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)	preoperative 1 days to postoperative 2 days
Secondary	recovery time	from injection of sugammadex or neostigmien to extubation and confirm of adequate spontaneous breathing	perioperative - until 48hours
Secondary	PACU(post-anesthesia care unit) stay time	from entry of PACU to go general ward	perioperative - until 48hours
Secondary	postoperative pain score	postoperative pain score measured by 11-point NRS(numerical rating scale) score (minimum : 0, maximum : 11, the lower the score, the lesser pain)	at postoperative 30minutes, 6hours, 24hours
Secondary	the incidence of administration of postoperative rescue drug	administration of analgesic drug and anti-emetic drug for postoperative management	perioperative - until 72hours
Secondary	hospital stay	days of hospital stay	preoperative - until discharge (usually 48 hours to 72hours)
Secondary	urinary retention	residual urine > 300ml diagnosed by bladder ultrasonography	postoperative - until discharge (usually 48 hours to 72hours)