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Remifentanil for Preventing Propofol Injection Pain 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: NCT03330782
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : July 5, 2019
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 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect-site Concentration of Remifentanil for Preventing Propofol Injection Pain in Elderly Patients: A Comparison With Adult Patients
Actual Study Start Date : November 16, 2017
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Elderly
Remifentanil was infused at predetermined effect-site concentration before propofol infusion in elderly patients.
Drug: Remifentanil
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 Name: Ultiva

Active Comparator: Adult
Remifentanil was infused at predetermined effect-site concentration before propofol infusion in adult patients.
Drug: Remifentanil
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 Name: Ultiva




Primary Outcome Measures :
  1. 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),

    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)



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03330782


Locations
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Korea, Republic of
Jong Yeop Kim
Suwon, Gyeonggi-do, Korea, Republic of, 443-721
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: Jong Yeop Kim Ajou University Hospital, Suwon, Gyeongki-do, South Korea, 443-721
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Responsible Party: Jong Yeop Kim, Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03330782    
Other Study ID Numbers: AJIRB-MED-OBS-17-197
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jong Yeop Kim, Ajou University School of Medicine:
pain
propofol
remifentanil
Additional relevant MeSH terms:
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Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents