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The Effect-site Concentration of Remifentanil for Preventing Cough During Emergence From Balanced Anesthesia for Nasal Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01291849
Enrollment
24
Registered
2011-02-09
Start date
2010-03-31
Completion date
2010-05-31
Last updated
2011-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

Keywords

nasal surgery, endoscopic sinus surgery, septoplasty, Cough

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.

Interventions

DRUGDixon up-and-down method

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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
cough incidencefrom sevoflurane discontinuation (at the end of anesthesia) to 5 min after extubationCough is defined as a strong and sudden contraction of the abdomen or forced exhalation movement.
cough gradefrom sevoflurane discontinuation (at the end of anesthesia) to 5 min after extubationCough 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026