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

Study Overview
=================
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.

Official Title
-----------------
Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics

Conditions
-----------------
Surgery, Individuality

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sufentanil group<br>Grouped by intravenous injection of sufentanil at the time of anesthesia induction | |
| Fentanyl group<br>Grouped by intravenous injection of fentanyl at the time of anesthesia induction | |
| Saline group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fentanyl, sufentanil, individual variation, pain threshold, nacro-trend index