The Realtime Detection for Individual Variation of Analgesic ：A Comparison of Sufentanil vs Fentanyl

NCT01748071 | Completed Results DMC

• 1 other identifier: Individual Variation
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This study aimed to find a quick and timely way to investigate the individual variation of efficacy of opioid analgesic in Chinese patients undergoing elective surgeries. Methods: 120 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 Narco-trend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system.

Conditions

Surgery; Individuality

Keywords

fentanyl; sufentanil; individual variation; pain threshold; nacro-trend index

Outcome Measures

Primary Outcomes (2)

• Mean Pressure Pain Threshold

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

  10 minutes after the procedure

• Mean Value of Narco-trend Index

  According to the measurement of Nacro-trend index after intravenous injection of opioid analgesics. Narco-trend index is from 0 to 100 which 0 represent deep sedation, and 100 represent waking state.

  10 minutes after the procedure

Secondary Outcomes (3)

• Mean Arterial Pressure

  10 minutes after the procedure

• Mean Heart Rate

  10 minutes after the procedure

• Mean Respiratory Frequency

  10 minutes after the procedure

Study Arms (3)

Sufentanil group

Grouped by intravenous injection of sufentanil at the time of anesthesia induction

Fentanyl group

Grouped by intravenous injection of fentanyl at the time of anesthesia induction

Saline group

Grouped by intravenous injection of saline before the time of anesthesia induction

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

120 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:

• 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

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

Limitations and Caveats

Because 3 patients couldn't maintain the SPO2 at 90% and 1 patient was at deep sedation, 4 subject patients were not analysed in the final results. These patients were performed as a routine intravenous anesthetic induction.

Results Point of Contact

• Title: Xianwei Zhang
• Organization: Huazhong University of Science&Technology

ourpain@163.com

027 83662853

Study Officials

• Zhang Xianwei, MD

  Huazhong University of Science and Technology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD.

Study Record Dates

• First Submitted: December 9, 2012
• First Posted: December 12, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 25, 2013
• Results First Posted: November 25, 2013

Record last verified: 2013-09

Locations

CN (1)