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

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.

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Key information

Conditions

Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dixon up-and-down method

Drug

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 outcomes

cough incidence

Time frame: from sevoflurane discontinuation (at the end of anesthesia) to 5 min after extubation

Cough is defined as a strong and sudden contraction of the abdomen or forced exhalation movement.
cough grade

Time frame: from sevoflurane discontinuation (at the end of anesthesia) to 5 min after extubation

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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2010
Study completion: 2010
First posted: Feb 9, 2011
Registry last updated: Feb 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed