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Completed

NCT Number: NCT01748071

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

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.

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Key information

Conditions

Surgery Individuality

Age range

20 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Dec 12, 2012
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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