The Realtime Detection for Prediction of Opioid Analgesic

This study is currently recruiting participants.
Verified May 2013 by Huazhong University of Science and Technology
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: NA
Last verified: May 2013
History: No changes posted
  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


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (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

200 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: NCT01868152

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 caie, MD       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: 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, 2013
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
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 17, 2014