N/A
Completed N=120
The Realtime Detection for Individual Variation of Analgesic ：A Comparison of Sufentanil vs Fentanyl
Surgery · Individuality
Source: ClinicalTrials.gov NCT01748071 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Mean Pressure Pain Threshold — 9.93; 6.20; 2.36 kg/cm2
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pressure Pain Threshold |
9.93; 6.20; 2.36 | — |
| PRIMARY Mean Value of Narco-trend Index |
50.9; 70.4; 93.7 | — |
| SECONDARY Mean Arterial Pressure |
90.1; 89.7; 90.3 | — |
| SECONDARY Mean Heart Rate |
77.9; 74.4; 77.6 | — |
| SECONDARY Mean Respiratory Frequency |
13.9; 12.3; 16.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01748071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.