Sugammadex and Smoker's Neuromuscular Block

April 11, 2022 updated by: Duzce University

The Evaluation of the Effects of the Use of Rocuronium and Sugammadex on Neuromuscular Block in Smoker

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

40 patients from American Society of Anesthesiologist (ASA) I- II class, being smokers for at least 10 years or non-smokers, who will undergo elective surgery were included in this randomized prospective study. Patients underwent routine monitoring and neuromuscular monitoring. Propofol 2 mg/kg and intravenous fentanyl 1 mcg/kg were applied at induction. After the loss of eyelash reflex, intravenous rocuronium 0,6 mg/kg was administered. The patient was intubated at a Train of Four count of 2. Anesthesia was continued with 50% O2 + 50% air and sevoflurane 2 % . Rocuronium 0,15 mg/kg was administered when TOF (Train of Four) counter reached 2 during the operation. Sugammadex 2 mg/kg was administered at the end of the operation. The time to reach Train of Four values of 0,7-0,8-0,9 were recorded.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective surgery,
  • 1-2 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Smokers
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
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
Other Names:
  • bridion
Sham Comparator: Nonsmokers
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
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
Other Names:
  • bridion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuromuscular block recovery time
Time Frame: six months
Time to reach TOF %90 measurement after given neuromuscular blocker reverse agent
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duzce University

Investigators

  • Study Director: Gulbin Sezen, Duzce University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012.04.HD.067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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