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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
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology

Study Description
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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.

Condition or disease
Surgery Individuality

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.

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl

Groups and Cohorts
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Group/Cohort
Sufentanil group
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Mean Respiratory Frequency [ Time Frame: 10 minutes after the procedure ]
    According to the measurement of respiratory frequency after intravenous injection of opioid analgesics


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes 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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Information from the National Library of Medicine

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


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
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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