Remifentanil for Preventing Propofol Injection Pain in Elderly Patients
Effect-site Concentration of Remifentanil for Preventing Propofol Injection Pain in Elderly Patients: A Comparison With Adult Patients
1 other identifier
interventional
52
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedStudy Start
First participant enrolled
November 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2018
CompletedJuly 5, 2019
July 1, 2019
7 months
October 30, 2017
July 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of propofol injection pain-4 point scale
0 = no pain (negative response to questioning), 1. = mild pain (pain reported only in response to questioning without any behavioral signs), 2. = moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontane¬ously without questioning), 3. = severe pain (vocal response accompanied by facial grimacing, arm withdrawal, or tears)
during 3 min after remifentanil and propofol infusion to reach the equilibrium of plasma and effect-site concentration
Study Arms (2)
Elderly
EXPERIMENTALRemifentanil was infused at predetermined effect-site concentration before propofol infusion in elderly patients.
Adult
ACTIVE COMPARATORRemifentanil was infused at predetermined effect-site concentration before propofol infusion in adult patients.
Interventions
Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in elderly patients (65-80 years)
Eligibility Criteria
You may qualify if:
- ASA physical status I or II undergoing general anesthesia
You may not qualify if:
- neurologic disorder
- psychologic disorder
- vascular disorder
- patients with chronic pain
- difficulty in vascular access
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jong Yeop Kim
Suwon, Gyeonggi-do, 443-721, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong Yeop Kim
Ajou University Hospital, Suwon, Gyeongki-do, South Korea, 443-721
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 30, 2017
First Posted
November 6, 2017
Study Start
November 16, 2017
Primary Completion
June 15, 2018
Study Completion
June 15, 2018
Last Updated
July 5, 2019
Record last verified: 2019-07