Remifentanil for Smooth Emergence in Elderly Patients

Drug Usage Clinical Trial

Official title:

Effect-site Concentration of Remifentanil for Preventing Cough During Emergence in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334046
• Other study ID #: AJIRB-MED-CT4-14-383
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2015
• Last updated: December 16, 2015
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anaesthetic drugs than younger patients. The purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing cough during emergence in elderly patients under sevoflurane and remifentanil anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA physical status I or II undergoing endoscopic sinus surgery or septoplasty under balanced anesthesia with sevoflurane and remifentanil

Exclusion Criteria:

• predicted difficult airway, body mass index > 30 kg/m2, history of obstructive sleep apnoea chronic respiratory disease or coughing, current smokers patients angiotensin converting enzyme-inhibitors

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Drug Usage

Intervention

Drug:
• Remifentanil
Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 1.8 ng/ml) in elderly patients (65-80 years) .
• Remifentanil
Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 1.8 ng/ml) in adult patients (20-60 years) .
• Sevoflurane
Anesthesia was maintained with sevoflurane with 1.5-2.0 vol% in air/50%oxygen mixture, and sevoflurane was adjusted to about 1.0 vol% 10 min before end of surgery.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeongki-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cough	Number of cough or a strong and sudden contraction of the abdomen during periextubation periods	from end of surgery to 5 min after tracheal extubation	Yes