The Realtime Detection for Individual Variation of Analgesic :A Comparison of Sufentanil vs Fentanyl
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ClinicalTrials.gov Identifier: NCT01748071 |
Recruitment Status
:
Completed
First Posted
: December 12, 2012
Results First Posted
: November 25, 2013
Last Update Posted
: November 25, 2013
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Condition or disease |
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Surgery Individuality |
Study Type : | Observational |
Actual Enrollment : | 120 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | February 2013 |

Group/Cohort |
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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
|
Saline group
Grouped by intravenous injection of saline before the time of anesthesia induction
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- Mean Pressure Pain Threshold [ Time Frame: 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 [ Time Frame: 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.
- Mean Arterial Pressure [ Time Frame: 10 minutes after the procedure ]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 ]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 ]According to the measurement of respiratory frequency after intravenous injection of opioid analgesics

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Ages Eligible for Study: | 20 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748071
China, Hubei | |
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | |
Wuhan, Hubei, China, 430030 |
Study Director: | Zhang Xianwei, MD | Huazhong University of Science and Technology |
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 |
First Posted: | December 12, 2012 Key Record Dates |
Results First Posted: | November 25, 2013 |
Last Update Posted: | November 25, 2013 |
Last Verified: | September 2013 |
Keywords provided by Xianwei Zhang, 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 |