- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03330782
Remifentanil for Preventing Propofol Injection Pain in Elderly Patients
July 2, 2019 updated by: Jong Yeop Kim, Ajou University School of Medicine
Effect-site Concentration of Remifentanil for Preventing Propofol Injection Pain in Elderly Patients: A Comparison With Adult Patients
Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anesthetic drugs than younger patients.
The purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing injection pain during propofol induction in elderly patients by the Dixon's up-and-down method.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Suwon, Gyeonggi-do, Korea, Republic of, 443-721
- Jong Yeop Kim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- ASA physical status I or II undergoing general anesthesia
Exclusion Criteria:
- neurologic disorder
- psychologic disorder
- vascular disorder
- patients with chronic pain
- difficulty in vascular access
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Elderly
Remifentanil was infused at predetermined effect-site concentration before propofol infusion in elderly patients.
|
Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in elderly patients (65-80 years)
Other Names:
Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in adult patients (20-60 years)
Other Names:
|
Active Comparator: Adult
Remifentanil was infused at predetermined effect-site concentration before propofol infusion in adult patients.
|
Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in elderly patients (65-80 years)
Other Names:
Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in adult patients (20-60 years)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of propofol injection pain-4 point scale
Time Frame: during 3 min after remifentanil and propofol infusion to reach the equilibrium of plasma and effect-site concentration
|
0 = no pain (negative response to questioning),
|
during 3 min after remifentanil and propofol infusion to reach the equilibrium of plasma and effect-site concentration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jong Yeop Kim, Ajou University Hospital, Suwon, Gyeongki-do, South Korea, 443-721
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 16, 2017
Primary Completion (Actual)
June 15, 2018
Study Completion (Actual)
June 15, 2018
Study Registration Dates
First Submitted
October 30, 2017
First Submitted That Met QC Criteria
October 31, 2017
First Posted (Actual)
November 6, 2017
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 2, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJIRB-MED-OBS-17-197
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Drug Usage
-
Oslo University HospitalUniversity of Oslo; South-Eastern Norway Regional Health Authority; City of OsloRecruiting
-
University of MichiganNational Institute on Drug Abuse (NIDA)Completed
-
Ajou University School of MedicineCompletedDrug UsageKorea, Republic of
-
Ajou University School of MedicineCompleted
-
Oslo University HospitalUniversity of Oslo; The Research Council of NorwayCompleted
-
Ain Shams UniversityUnknown
-
South Valley UniversityTanta UniversityCompletedIntravenous Drug UsageEgypt
-
Rockefeller UniversityCompletedIntravenous Drug UsageUnited States
-
University of New MexicoTerminatedIntravenous Drug UsageUnited States
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); UNC Injury Prevention Research CenterCompletedIntravenous Drug UsageUnited States
Clinical Trials on Remifentanil
-
University Medical Center GroningenCompletedAnesthesia | Hemodynamic Instability | Interaction | Disorder of Oxygen TransportNetherlands
-
Inje UniversityCompletedStrabismusKorea, Republic of
-
Ciusss de L'Est de l'Île de MontréalCompletedIntubation; Difficult or FailedCanada
-
Helse FonnaCompletedAnesthesia, General | Anesthesia, Intravenous | Hemodynamic InstabilityNorway
-
Hopital FochCompletedGeneral AnesthesiaFrance
-
Zhang HaopengCompleted
-
Seoul National University HospitalAjou University School of Medicine; Severance HospitalCompletedInfant, PretermKorea, Republic of
-
Capital Medical UniversityRecruitingCerebral Blood Flow | Hyperventilation | Aneurysmal Subarachnoid HemorrhageChina
-
University of AarhusMech-SenseCompleted
-
University Hospital, GhentCompleted