The Realtime Detection for Individual Variation of Analgesic ：A Comparison of Sufentanil vs Fentanyl

Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics

Purpose: This study aimed to find a quick and timely way to investigate the individual variation of efficacy of opioid analgesic in Chinese patients undergoing elective surgeries. Methods: 120 female patients receiving elective surgery under general anesthesia were recruited into this study. At the time of routine intravenous anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect, effects on Narco-trend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system.

Study Overview

• Status: Completed
• Conditions: Surgery; Individuality

Detailed Description

Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

120 Chinese female patients receiving elective surgery under general anesthesia

Description

Inclusion Criteria:

• Aged 20-65 years
• Anesthesiologists (ASA) physical status I or II;
• Within ±20% of ideal body weight;
• Agreed to participate the research

Exclusion Criteria:

• History of chronic pain;
• Psychiatric diseases;
• Diabetes mellitus;
• Severe cardiovascular diseases;
• Kidney or liver diseases;
• Alcohol or drug abuse (according to the criteria of DSM-IV);
• Pregnancy or at lactation period;
• Disagree to participate to the research

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Sufentanil group; Grouped by intravenous injection of sufentanil at the time of anesthesia induction
Fentanyl group; Grouped by intravenous injection of fentanyl at the time of anesthesia induction
Saline group; Grouped by intravenous injection of saline before the time of anesthesia induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Pressure Pain Threshold	According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics	10 minutes after the procedure
Mean Value of Narco-trend Index	According to the measurement of Nacro-trend index after intravenous injection of opioid analgesics. Narco-trend index is from 0 to 100 which 0 represent deep sedation, and 100 represent waking state.	10 minutes after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Pressure	According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics	10 minutes after the procedure
Mean Heart Rate	According to the measurement of heart rate before and after intravenous injection of opioid analgesics	10 minutes after the procedure
Mean Respiratory Frequency	According to the measurement of respiratory frequency after intravenous injection of opioid analgesics	10 minutes after the procedure

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Director: Zhang Xianwei, MD, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: December 9, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: September 22, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: fentanyl; sufentanil; individual variation; pain threshold; nacro-trend index
• Other Study ID Numbers: Individual Variation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No