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

This study is currently recruiting participants.
Verified December 2012 by Huazhong University of Science and Technology
Sponsor:
Information provided by (Responsible Party):
Zhang Xianwei, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01748071
First received: December 9, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  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 Nacro-trend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system.


Condition
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:

U.S. FDA Resources

Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Rangeability of pressure pain threshold [ Time Frame: 5 month ] [ Designated as safety issue: Yes ]
    According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics

  • Rangeability of Nacro-trend index [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    According to the measurement of Nacro-trend index before and after intravenous injection of opioid analgesics


Secondary Outcome Measures:
  • Rangeability of Ramsay Sedation Scale [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    According to the investigation of Ramsay Sedation Scale before and after intravenous injection of opioid analgesics

  • Rangeability of mean arterial pressure [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics

  • Rangeability of heart rate [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    According to the measurement of heart rate before and after intravenous injection of opioid analgesics

  • Rangeability of respiratory frequency [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    According to the measurement of respiratory frequency before and after intravenous injection of opioid analgesics


Estimated Enrollment: 120
Study Start Date: June 2012
Estimated Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748071

Contacts
Contact: Zhang Xianwei, MD 13037154560 znpain@sina.com

Locations
China, Hubei
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Zhang Cai'e, Doctor         zhangcaie1972@126.com    
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Study Director: Zhang Xianwei, MD Huazhong University of Science and Technology
  More Information

No publications provided

Responsible Party: Zhang Xianwei, 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
Last Updated: December 10, 2012
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:
Analgesics
Fentanyl
Sufentanil
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 23, 2013