The Realtime Detection for Prediction of Opioid Analgesic

Completed

• Conditions: Surgery; Individuality

• Registration Number: NCT01868152
• Lead Sponsor: Huazhong University of Science and Technology

Brief 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: 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.

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-19
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rangeability of pressure pain threshold	8 months	According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics

Secondary Outcome Measures

Name	Time	Method
Rangeability of Narcotrend index	8 months	According to the measurement of Narcotrend index before and after intravenous injection of opioid analgesics
Rangeability of Ramsay Sedation Scale	8 months	According to the investigation of Ramsay Sedation Scale before and after intravenous injection of opioid analgesics
Rangeability of respiratory frequency	8 months	According to the measurement of respiratory frequency before and after intravenous injection of opioid analgesics

Trial Locations

Locations (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China