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Clinical Trials/NCT03330782
NCT03330782
Completed
Phase 4

Effect-site Concentration of Remifentanil for Preventing Propofol Injection Pain in Elderly Patients: A Comparison With Adult Patients

Ajou University School of Medicine1 site in 1 country52 target enrollmentNovember 16, 2017
ConditionsDrug Usage
InterventionsRemifentanil

Overview

Phase
Phase 4
Intervention
Remifentanil
Conditions
Drug Usage
Sponsor
Ajou University School of Medicine
Enrollment
52
Locations
1
Primary Endpoint
Severity of propofol injection pain-4 point scale
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 16, 2017
End Date
June 15, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Ajou University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Jong Yeop Kim

Professor

Ajou University School of Medicine

Eligibility 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

Arms & Interventions

Elderly

Remifentanil was infused at predetermined effect-site concentration before propofol infusion in elderly patients.

Intervention: Remifentanil

Adult

Remifentanil was infused at predetermined effect-site concentration before propofol infusion in adult patients.

Intervention: Remifentanil

Outcomes

Primary Outcomes

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)

Study Sites (1)

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