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

This study has been completed.
Sponsor:
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
  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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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:
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 July 29, 2014