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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05313100
Other study ID # 2012.04.HD.067
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2012
Est. completion date August 2013

Study information

Verified date April 2022
Source Duzce University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Duzce University

Outcome

Type Measure Description Time frame Safety issue
Primary Neuromuscular block recovery time Time to reach TOF %90 measurement after given neuromuscular blocker reverse agent six months
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