Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

Neuromuscular Block, Residual Clinical Trial

Official title:

Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery: Comparison of Neostigmine and Sugammadex

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292965
• Other study ID #: B-1609-363-002
• Status: Completed
• Phase: N/A
• Start date: September 28, 2017
• Est. completion date: November 29, 2017

Study information

• Verified date: October 2018
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular monitoring value (TOF). After the administration of reversal, the anesthesiologist who are going to manage the participant should not check the quantitative neuromuscular monitoring and determine the timing of extubation only with his (or her) judgement. After entering post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio > 0.9 between the neostigmine group and sugammadex group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neuromuscular Block, Residual

Intervention

Drug:
• Neostigmine
Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal
• Sugammadex
Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of postoperative residual curarization	definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9	Immediately after entering PACU