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Reversal of Neuromuscular Blockade and Perioperative Arrhythmias

NCT04720573 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-01-22

No results posted yet for this study

Summary

Patients scheduled for elective abdominopelvic laparoscopic surgery under general anesthesia were included. Rocuronium was used for the neuromuscular blockade (NMB) and the level of NMB was monitored with train-of-four (TOF) measurements. The participants from whom informed consent had been received were allocated to two groups according to the agent used for reversal of NMB, sugammadex, or neostigmine. The ECG recordings of the subjects were followed with a rhythm Holter device throughout the procedure until the postoperative 12th hour. Additionally, preoperative and immediate postoperative 12-lead ECGs were evaluated for corrected QT calculations and QT dispersion. Proarrhythmogenicity was assessed with QT related measurements. The documented arrhythmic events on the Holter monitoring were designated as clinical end-points.

Conditions

  • Neuromuscular Blockade

Interventions

DRUG

Neostigmine

50 mcg/kg neostigmine was used under the guidance of TOF monitoring after cessation of anesthesia.

DRUG

Sugammadex

2 mg/kg sugammadex was used under the guidance of TOF monitoring after cessation of anesthesia.

Sponsors & Collaborators

  • Medipol University

    collaborator OTHER

  • Başakşehir Çam & Sakura City Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2019-10-01
Completion
2019-11-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04720573 on ClinicalTrials.gov