Sugammadex and Smoker's Neuromuscular Block

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313100
• Other study ID #: 2012.04.HD.067
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Neuromuscular Blockade
• Smoking

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