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

NCT01291849 | Completed Phase 4

• 1 other identifier: 4-2009-0578
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Keywords

nasal surgery; endoscopic sinus surgery; septoplasty; Cough

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

remifentanil for intranasal surgery

EXPERIMENTAL

Drug: Dixon up-and-down method

Interventions

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.

remifentanil for intranasal surgery

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 19411668 BACKGROUND

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 9, 2011
• Study Start: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 9, 2011

Record last verified: 2011-01

Locations

KR (1)