NCT04720573

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

January 19, 2021

Last Update Submit

January 19, 2021

Conditions

Neuromuscular Blockade

Keywords

BradycardiaCardiac ArrhythmiasNeostigmineNeuromuscular BlockadeSugammadexTrain-of-Four Monitoring

Outcome Measures

Primary Outcomes (1)

  • Significant arrhythmic event

    Pause (no waves on ECG recording at least for 3 seconds), significant bradycardia (sinus bradycardia persisted at least for 30 seconds with a rate below 50 beats/min), high-grade atrioventricular block (2nd-degree Mobitz Type II or 3rd degree), supraventricular tachycardia (sudden onset tachycardia with narrow QRS complexes persisted over 30 seconds), atrial flutter or fibrillation (sustained over 30 seconds), Frequent premature ventricular beats (≥30 beats/hour).

    Up to 12 hours after surgical procedure

Study Arms (2)

Group N

ACTIVE COMPARATOR

Neostigmine was used for the reversal of neuromuscular blockade.

Drug: Neostigmine

Group S

ACTIVE COMPARATOR

Sugammadex was used for the reversal of neuromuscular blockade.

Drug: Sugammadex

Interventions

NeostigmineDRUG

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

Group N
SugammadexDRUG

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

Group S

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned abdominopelvic surgery under general anesthesia
  • ASA II-IV
  • Willing to give consent

You may not qualify if:

  • Significantly impaired left ventricular systolic function (ejection fraction \< 40%)
  • Significant ongoing arrhythmia (sinus bradycardia with a heart rate below 40 beats/min, Mobitz Type II or 3rd-grade atrioventricular block, persistent or permanent atrial flutter or fibrillation, bigeminal or trigeminal ventricular premature beats, documented ventricular tachycardia)
  • Severely reduced renal function (glomerular filtration rate \< 30 ml/min/1.73 m2)
  • Severe respiratory diseases, neuromuscular disorders, and known allergy to anesthetic agents or adjuvants
  • Pregnancy and breastfeeding
  • Observing the typical signs of a channelopathy (short QT syndrome, long QT syndrome, Brugada syndrome, etc.) and history of recent medical therapy with agents exhibiting a high probability of QT prolongation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34214, Turkey (Türkiye)

Location

Related Publications (7)

  • Lorentz MN, Vianna BS. Cardiac dysrhythmias and anesthesia. Rev Bras Anestesiol. 2011 Nov-Dec;61(6):798-813. doi: 10.1016/S0034-7094(11)70090-3. English, Multiple languages.

    PMID: 22063382BACKGROUND

  • Dahl V, Pendeville PE, Hollmann MW, Heier T, Abels EA, Blobner M. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Eur J Anaesthesiol. 2009 Oct;26(10):874-84. doi: 10.1097/EJA.0b013e32832c605b.

    PMID: 19455040BACKGROUND

  • Kizilay D, Dal D, Saracoglu KT, Eti Z, Gogus FY. Comparison of neostigmine and sugammadex for hemodynamic parameters in cardiac patients undergoing noncardiac surgery. J Clin Anesth. 2016 Feb;28:30-5. doi: 10.1016/j.jclinane.2015.08.002. Epub 2015 Nov 11.

    PMID: 26796612BACKGROUND

  • Staikou C, Stamelos M, Stavroulakis E. Impact of anaesthetic drugs and adjuvants on ECG markers of torsadogenicity. Br J Anaesth. 2014 Feb;112(2):217-30. doi: 10.1093/bja/aet412. Epub 2013 Dec 3.

    PMID: 24305646RESULT

  • Carron M, Zarantonello F, Tellaroli P, Ori C. Efficacy and safety of sugammadex compared to neostigmine for reversal of neuromuscular blockade: a meta-analysis of randomized controlled trials. J Clin Anesth. 2016 Dec;35:1-12. doi: 10.1016/j.jclinane.2016.06.018. Epub 2016 Aug 4.

    PMID: 27871504RESULT

  • Hristovska AM, Duch P, Allingstrup M, Afshari A. The comparative efficacy and safety of sugammadex and neostigmine in reversing neuromuscular blockade in adults. A Cochrane systematic review with meta-analysis and trial sequential analysis. Anaesthesia. 2018 May;73(5):631-641. doi: 10.1111/anae.14160. Epub 2017 Dec 27.

    PMID: 29280475RESULT

  • Yamashita Y, Takasusuki T, Kimura Y, Komatsuzaki M, Yamaguchi S. Effects of Neostigmine and Sugammadex for Reversal of Neuromuscular Blockade on QT Dispersion Under Propofol Anesthesia: A Randomized Controlled Trial. Cardiol Ther. 2018 Dec;7(2):163-172. doi: 10.1007/s40119-018-0119-9. Epub 2018 Sep 14.

    PMID: 30218410RESULT

Related Links

MeSH Terms

Conditions

BradycardiaArrhythmias, Cardiac

Interventions

NeostigmineSugammadex

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compoundsgamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator assessing the ECGs, and rhythm holter recordings was blinded to randomization.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1:1 randomization
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 22, 2021

Study Start

June 1, 2019

Primary Completion

October 1, 2019

Study Completion

November 1, 2019

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)