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

Completed

• Conditions: Individuality; Surgery

• Registration Number: NCT01748071
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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.

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 Timeline

• Study Start: 2012-06
• Primary Completion: 2012-12
• Study First Submitted: 2012-12-09
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Study Completion: 2013-02
• Results First Submitted: 2013-05-30
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-22
• Last Update Submitted: 2013-09-22
• Results First Posted: 2013-11-25
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Pressure Pain Threshold	10 minutes after the procedure	According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics
Mean Value of Narco-trend Index	10 minutes after the procedure	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China