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

Surgery Clinical Trial

Official title:

Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748071
• Other study ID #: Individual Variation
• Status: Completed
• Phase: N/A
• First received: December 9, 2012
• Last updated: September 22, 2013
• Start date: June 2012
• Est. completion date: February 2013

Study information

• Verified date: September 2013
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Individuality
• Surgery

Locations

Country	Name	City	State
China	Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Pressure Pain Threshold	According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics	10 minutes after the procedure	Yes
Primary	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	Yes
Secondary	Mean Arterial Pressure	According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics	10 minutes after the procedure	Yes
Secondary	Mean Heart Rate	According to the measurement of heart rate before and after intravenous injection of opioid analgesics	10 minutes after the procedure	Yes
Secondary	Mean Respiratory Frequency	According to the measurement of respiratory frequency after intravenous injection of opioid analgesics	10 minutes after the procedure	Yes