The Realtime Detection for Prediction of Opioid Analgesic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01868152
First received: May 30, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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: 200 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.


Condition
Surgery
Individuality

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Study of Prediction of Opioid Analgesic

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

Primary Outcome Measures:
  • Rangeability of pressure pain threshold [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics


Secondary Outcome Measures:
  • Rangeability of Narcotrend index [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    According to the measurement of Narcotrend index before and after intravenous injection of opioid analgesics

  • Rangeability of Ramsay Sedation Scale [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    According to the investigation of Ramsay Sedation Scale before and after intravenous injection of opioid analgesics

  • Rangeability of respiratory frequency [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    According to the measurement of respiratory frequency before and after intravenous injection of opioid analgesics


Enrollment: 111
Study Start Date: April 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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

111 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01868152

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: NCT01868152     History of Changes
Other Study ID Numbers: Predictive opioid
Study First Received: May 30, 2013
Last Updated: May 30, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Huazhong University of Science and Technology:
sufentanil
individual variation
pain threshold
narcotrend index

Additional relevant MeSH terms:
Analgesics
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on August 26, 2014