The Realtime Detection for Individual Variation of Analgesic ：A Comparison of Sufentanil vs Fentanyl
This study has been completed.
Sponsor:
Huazhong University of Science and Technology
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01748071
First received: December 9, 2012
Last updated: September 22, 2013
Last verified: September 2013
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Purpose
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.
| Condition |
|---|
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Surgery Individuality |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics |
Resource links provided by NLM:
Further study details as provided by Huazhong University of Science and Technology:
Primary Outcome Measures:
- Mean Pressure Pain Threshold [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics
- Mean Value of Narco-trend Index [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]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:
- Mean Arterial Pressure [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics
- Mean Heart Rate [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]According to the measurement of heart rate before and after intravenous injection of opioid analgesics
- Mean Respiratory Frequency [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]According to the measurement of respiratory frequency after intravenous injection of opioid analgesics
| Enrollment: | 120 |
| Study Start Date: | June 2012 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Sufentanil group
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
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Fentanyl group
Grouped by intravenous injection of fentanyl at the time of anesthesia induction
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Saline group
Grouped by intravenous injection of saline before the time of anesthesia induction
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
120 Chinese female patients receiving elective surgery under general anesthesia
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01748071
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748071
Locations
| China, Hubei | |
| Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | |
| Wuhan, Hubei, China, 430030 | |
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
| Study Director: | Zhang Xianwei, MD | Huazhong University of Science and Technology |
More Information
| Responsible Party: | Xianwei Zhang, Professor, MD., Huazhong University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT01748071 History of Changes |
| Other Study ID Numbers: | Individual Variation |
| Study First Received: | December 9, 2012 |
| Results First Received: | May 30, 2013 |
| Last Updated: | September 22, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Huazhong University of Science and Technology:
|
fentanyl sufentanil individual variation pain threshold nacro-trend index |
Additional relevant MeSH terms:
|
Fentanyl Sufentanil Analgesics Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on September 29, 2016