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Completed

NCT Number: NCT01868152

The Realtime Detection for Prediction of Opioid Analgesic

This study aimed to find a quick and timely way to predict the individual variation of efficacy of opioid analgesic during the operation and postoperative analgesia in Chinese patients undergoing elective surgeries. Methods: 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 Narcotrend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system. Then we record the consumption of of opioid analgesic during the operation and postoperative analgesia. Also we record the side effect of the opioid analgesic.

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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. Rangeability of pressure pain threshold

    Time frame: 8 months

    According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics

Secondary outcomes

  1. Rangeability of Narcotrend index

    Time frame: 8 months

    According to the measurement of Narcotrend index before and after intravenous injection of opioid analgesics

  2. Rangeability of Ramsay Sedation Scale

    Time frame: 8 months

    According to the investigation of Ramsay Sedation Scale before and after intravenous injection of opioid analgesics

  3. Rangeability of respiratory frequency

    Time frame: 8 months

    According to the measurement of respiratory frequency before and 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 Prediction of Opioid Analgesic

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2013
Registry last updated
Mar 22, 2016

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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