The Effect-site Concentration of Remifentanil for Preventing Cough During Emergence From Balanced Anesthesia for Nasal Surgery
Primary Purpose
Cough
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dixon up-and-down method
Sponsored by

About this trial
This is an interventional treatment trial for Cough focused on measuring nasal surgery, endoscopic sinus surgery, septoplasty, Cough
Eligibility Criteria
Inclusion Criteria:
- all male aged 18-60 years
- ASA(American Society of Anesthesiologists)physical status I or II
- who underwent ESS(endoscopic sinus surgery)or septoplasty under sevoflurane-remifentanil balanced anesthesia
Exclusion Criteria:
- predicted difficult airway,
- BMI(Body Mass Index) of more than 30 kg/m2,
- chronic respiratory disease,
- recent respiratory track infection,
- chronic coughing,
- significant cardiovascular,
- hepatic or renal disease,
- current smokers
- medical history of medication of opioid or ACEI(angiotensin covering enzyme inhibitor)
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
remifentanil for intranasal surgery
Arm Description
Outcomes
Primary Outcome Measures
cough incidence
Cough is defined as a strong and sudden contraction of the abdomen or forced exhalation movement.
cough grade
Cough occurrence and number are recorded according to the grading system as follow; Grade 0 - no cough Grade 1 - light (single) cough Grade 2 - moderate cough (more than 1 episode of non-sustained cough) Grade 3 - sustained and repetitive cough movement and head lift.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01291849
Brief Title
The Effect-site Concentration of Remifentanil for Preventing Cough During Emergence From Balanced Anesthesia for Nasal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
After nasal surgery, emergence cough or straining will produce venous engorgement and increase bleeding from the surgical site, so the necessity for smooth extubation without severe cough during emergence provides a challenge for the anesthetists. Recently, remifentanil is commonly used short-acting opioid, and several studies have demonstrated the antitussive effect of remifentanil via effect-site target-controlled infusion during emergence. However, there may be gender difference in response to opioid, and the previous studies about antitussive effect of remifentanil are targeted at female patients and there is no investigation of effect site concentration of remifentanil for male patients undergoing nasal surgery. The purpose of this study is to evaluate the effect-site concentration of remifentanil via target-controlled infusion for preventing cough in man after sevofluorane balanced anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
nasal surgery, endoscopic sinus surgery, septoplasty, Cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
remifentanil for intranasal surgery
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dixon up-and-down method
Intervention Description
The target Ce of remifentanil was determined by the response of the previous patient using Dixon's up-and-down method. If the patients did not cough throughout peri-extubation period, the extubation was defined as a smooth emergence, and the predetermined concentration of remifentanil for the subsequent patient was decreased by 0.5 ng ml-1. Similarly, if the patient cough anytime around extubation it was considered as failed smooth emergence and the predetermined concentration was increased by 0.5 ng ml-1 for the next patient. The patients were enrolled until getting at least six cross-over pairs in Dixon sequential allocation method.
Primary Outcome Measure Information:
Title
cough incidence
Description
Cough is defined as a strong and sudden contraction of the abdomen or forced exhalation movement.
Time Frame
from sevoflurane discontinuation (at the end of anesthesia) to 5 min after extubation
Title
cough grade
Description
Cough occurrence and number are recorded according to the grading system as follow; Grade 0 - no cough Grade 1 - light (single) cough Grade 2 - moderate cough (more than 1 episode of non-sustained cough) Grade 3 - sustained and repetitive cough movement and head lift.
Time Frame
from sevoflurane discontinuation (at the end of anesthesia) to 5 min after extubation
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all male aged 18-60 years
ASA(American Society of Anesthesiologists)physical status I or II
who underwent ESS(endoscopic sinus surgery)or septoplasty under sevoflurane-remifentanil balanced anesthesia
Exclusion Criteria:
predicted difficult airway,
BMI(Body Mass Index) of more than 30 kg/m2,
chronic respiratory disease,
recent respiratory track infection,
chronic coughing,
significant cardiovascular,
hepatic or renal disease,
current smokers
medical history of medication of opioid or ACEI(angiotensin covering enzyme inhibitor)
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
19411668
Citation
Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009 Jun;102(6):775-8. doi: 10.1093/bja/aep090. Epub 2009 May 2.
Results Reference
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The Effect-site Concentration of Remifentanil for Preventing Cough During Emergence From Balanced Anesthesia for Nasal Surgery
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