The Realtime Detection for Prediction of Opioid Analgesic

NCT01868152 | Completed DMC

• 1 other identifier: Predictive opioid
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Individuality

Keywords

sufentanil; individual variation; pain threshold; narcotrend index

Outcome Measures

Primary Outcomes (1)

• Rangeability of pressure pain threshold

  According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics

  8 months

Secondary Outcomes (3)

• Rangeability of Narcotrend index

  8 months

• Rangeability of Ramsay Sedation Scale

  8 months

• Rangeability of respiratory frequency

  8 months

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese female patients receiving elective surgery under general anesthesia

You may qualify if:

• Aged 20-65 years
• Anesthesiologists (ASA) physical status I or II;
• Within ±20% of ideal body weight;
• Agreed to participate the research

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Officials

• Zhang Xianwei, MD

  Huazhong University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD.

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

CN (1)