MedDataX Logo

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

NCT ID: NCT01748071

Last Updated: 2013-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery Individuality

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

fentanyl sufentanil individual variation pain threshold nacro-trend index

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sufentanil group

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

No interventions assigned to this group

Fentanyl group

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

No interventions assigned to this group

Saline group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xianwei Zhang

Professor, MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhang Xianwei, MD

Role: STUDY_DIRECTOR

Huazhong University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Wuhan, Hubei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Individual Variation

Identifier Type: -

Identifier Source: org_study_id