Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

NCT03292965 | Completed

• 1 other identifier: B-1609-363-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular monitoring

Conditions

Neuromuscular Block, Residual

Outcome Measures

Primary Outcomes (1)

• the incidence of postoperative residual curarization

  definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9

  Immediately after entering PACU

Study Arms (2)

Neostigmine

ACTIVE COMPARATOR

At the end of surgery, administrating neostigmine to participants according to the protocol below: when train-of-four (TOF) 2-3, administrating neostigmine 50mcg/kg when TOF 4 with fade, administrating neostigmine 40mcg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg

Drug: Neostigmine

Sugammadex

ACTIVE COMPARATOR

At the end of surgery, administrating sugammadex to participants according to the protocol below: when TOF=0 and post-tetanic count (PTC)=1 or more, administrating sugammadex 4mg/kg when TOF=1 or more, administrating sugammadex 2mg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg

Drug: Sugammadex

Interventions

Neostigmine DRUG

Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal

Neostigmine

Sugammadex DRUG

Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal

Also known as: Bridion

Sugammadex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged over 18 years, planned to undergoing elective laparoscopic surgery under general anesthesia

You may not qualify if:

• Obesity BMI over 30 kg/m2
• Impairment of renal or/and liver function
• Allergy to rocuronium, sugammadex
• (Familial) history of malignant hyperthermia
• Taking medicines which is affecting neuromuscular function

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

Related Publications (1)

• Lee YJ, Oh AY, Koo BW, Han JW, Park JH, Hong JP, Seo KS. Postoperative residual neuromuscular blockade after reversal based on a qualitative peripheral nerve stimulator response: A randomised controlled trial. Eur J Anaesthesiol. 2020 Mar;37(3):196-202. doi: 10.1097/EJA.0000000000001157.

  PMID: 31977627 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Neostigmine; Sugammadex

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• AhYoung Oh, M.D Ph. D

  Department of anesthesiology and pain medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor of department of anesthesiology and pain medicine

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: September 28, 2017
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

KR (1)