Remifentanil for Preventing Propofol Injection Pain in Elderly 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.

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Key information

Conditions

Drug Usage Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Jong Yeop Kim

Suwon, Gyeonggi-do, 443-721, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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: Ultiva

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),
- = mild pain (pain reported only in response to questioning without any behavioral signs),
- = moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontane¬ously without questioning),
- = severe pain (vocal response accompanied by facial grimacing, arm withdrawal, or tears)

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Nov 6, 2017
Registry last updated: Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed