The Realtime Detection for Prediction of Opioid Analgesic

Study of Prediction of Opioid Analgesic

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Individuality

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 Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Chinese female patients receiving elective surgery under general anesthesia

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rangeability of pressure pain threshold	According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics	8 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Director: Zhang Xianwei, MD, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Estimate): March 22, 2016
• Last Update Submitted That Met QC Criteria: March 19, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: sufentanil; individual variation; pain threshold; narcotrend index
• Other Study ID Numbers: Predictive opioid