Remifentanil for Preventing Propofol Injection Pain in Elderly Patients

Drug Usage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330782
• Other study ID #: AJIRB-MED-OBS-17-197
• Status: Completed
• Phase: Phase 4
• Start date: November 16, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: July 2019
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Usage

Intervention

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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Jong Yeop Kim	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of propofol injection pain-4 point scale	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)	during 3 min after remifentanil and propofol infusion to reach the equilibrium of plasma and effect-site concentration