Remifentanil for Smooth Emergence in Elderly Patients

NCT02334046 | Completed Phase 4 DMC

• 1 other identifier: AJIRB-MED-CT4-14-383
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Usage

Keywords

tracheal extubation; remifentanil

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Elderly

EXPERIMENTAL

Remifentanil was maintained at predetermined effect-site concentration during the emergence period in elderly patients.

Drug: Remifentanil; Drug: Sevoflurane

Adult

ACTIVE COMPARATOR

Remifentanil was maintained at predetermined effect-site concentration during the emergence period in adult patients.

Drug: Remifentanil; Drug: Sevoflurane

Interventions

Remifentanil DRUG

Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 1.8 ng/ml) in elderly patients (65-80 years) .

Also known as: Ultiva

Adult

Sevoflurane DRUG

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.

Adult; Elderly

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeongki-do, 443-721, South Korea

Location

MeSH Terms

Interventions

Remifentanil; Sevoflurane

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Jong Yeop Kim

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

KR (1)