The Realtime Detection for Prediction of Opioid Analgesic

Surgery Clinical Trial

Official title:

Study of Prediction of Opioid Analgesic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868152
• Other study ID #: Predictive opioid
• 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

• Individuality
• Surgery

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