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Sugammadex and Smoker's Neuromuscular Block

Sponsor
Duzce University (Other)
Overall Status
Completed
CT.gov ID
NCT05313100
Collaborator
(none)
40
Enrollment
2
Arms
16
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Evaluation of the Effects of the Use of Rocuronium and Sugammadex on Neuromuscular Block in Smoker
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Neuromuscular block recovery time [six months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Duzce University

    Investigators

    • Study Director: Gulbin Sezen, Duzce University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duzce University
    ClinicalTrials.gov Identifier:
    NCT05313100
    Other Study ID Numbers:
    • 2012.04.HD.067
    First Posted:
    Apr 6, 2022
    Last Update Posted:
    Apr 18, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Duzce University
    sugammadex
    smoking
    neuromuscular blockade

    Study Results

    No Results Posted as of Apr 18, 2022