NCT05313100

Brief Summary

We compared the durations of antagonizing and of the severity of effect of sugammadex used in antagonizing the rocuronium in smoker and non-smoker total 40 patients with using Train of Four(TOF) neuromuscular monitorization.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2012

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
6.7 years until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

August 6, 2015

Last Update Submit

April 11, 2022

Conditions

Neuromuscular BlockadeSmoking

Keywords

sugammadexsmokingneuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • Neuromuscular block recovery time

    Time to reach TOF %90 measurement after given neuromuscular blocker reverse agent

    six months

Study Arms (2)

Smokers

ACTIVE COMPARATOR

The patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking were included in the smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used.

Drug: sugammadex

Nonsmokers

SHAM COMPARATOR

The patients who never smoked were included in the non-smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used.

Drug: sugammadex

Interventions

sugammadexDRUG

At the end of the operation, at least 15 minutes after the last dose of rocuronium, sugammadex 2 mg / kg was administered both of groups

Also known as: bridion
NonsmokersSmokers

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective surgery,
  • according to the ASA ( American Society of Anesthesiologist ) physical status classification.
  • Patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking
  • Or never smoked patients

You may not qualify if:

  • neuromuscular diseases
  • radiotherapy and/or chemotherapy anamnesis,
  • liver and/or renal disease,
  • electrolyte balance,
  • history of drug use which affects neuromuscular transmission,
  • Body Mass Index (BMI) of more than 27,
  • use alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Gulbin Sezen

    Duzce University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2015

First Posted

April 6, 2022

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Study Completion

August 1, 2013

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share