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.

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Drug: Dixon up-and-down method

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: remifentanil for intranasal surgery

Drug: Dixon 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cough incidence	Cough is defined as a strong and sudden contraction of the abdomen or forced exhalation movement.	from sevoflurane discontinuation (at the end of anesthesia) to 5 min after extubation
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.	from sevoflurane discontinuation (at the end of anesthesia) to 5 min after extubation

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: February 8, 2011
• First Posted (Estimate): February 9, 2011

Study Record Updates

• Last Update Posted (Estimate): February 9, 2011
• Last Update Submitted That Met QC Criteria: February 8, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Cough; septoplasty; endoscopic sinus surgery; nasal surgery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 4-2009-0578