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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01868152
Other study ID # Predictive opioid
Secondary ID
Status Completed
Phase N/A
First received May 30, 2013
Last updated December 15, 2014
Start date April 2013
Est. completion date April 2014

Study information

Verified date December 2014
Source Huazhong University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rangeability of pressure pain threshold According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics 8 months Yes
Secondary Rangeability of Narcotrend index According to the measurement of Narcotrend index before and after intravenous injection of opioid analgesics 8 months Yes
Secondary Rangeability of Ramsay Sedation Scale According to the investigation of Ramsay Sedation Scale before and after intravenous injection of opioid analgesics 8 months Yes
Secondary Rangeability of respiratory frequency According to the measurement of respiratory frequency before and after intravenous injection of opioid analgesics 8 months Yes
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