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Remifentanil for Smooth Emergence in Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02334046
Recruitment Status : Completed
First Posted : January 8, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Jong Yeop Kim, Ajou University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Drug Usage Drug: Remifentanil Drug: Sevoflurane Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect-site Concentration of Remifentanil for Preventing Cough During Emergence in Elderly Patients
Study Start Date : February 2015
Primary Completion Date : November 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Elderly
Remifentanil was maintained at predetermined effect-site concentration during the emergence period in elderly patients.
Drug: 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) .
Other Name: Ultiva
Drug: 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.
Active Comparator: Adult
Remifentanil was maintained at predetermined effect-site concentration during the emergence period in adult patients.
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) .
Other Name: Ultiva
Drug: 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.



Primary Outcome Measures :
  1. Number of cough [ Time Frame: from end of surgery to 5 min after tracheal extubation ]
    Number of cough or a strong and sudden contraction of the abdomen during periextubation periods



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334046


Locations
Korea, Republic of
Ajou University Hospital
Suwon, Gyeongki-do, Korea, Republic of, 443-721
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: Jong Yeop Kim Ajou University School of Medicine

Responsible Party: Jong Yeop Kim, Associate professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02334046     History of Changes
Other Study ID Numbers: AJIRB-MED-CT4-14-383
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015

Keywords provided by Jong Yeop Kim, Ajou University School of Medicine:
tracheal extubation
remifentanil

Additional relevant MeSH terms:
Remifentanil
Sevoflurane
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation