SurgeryNCT01868152
The Realtime Detection for Prediction of Opioid Analgesic
An observational study of Surgery and Individuality, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Surgery, Individuality
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Chinese female patients receiving elective surgery under general anesthesia
Who may be able to join
- Aged 20-65 years
- Anesthesiologists (ASA) physical status I or II;
- Within ±20% of ideal body weight;
- Agreed to participate the research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery, Individuality
- Keywords
- sufentanil, individual variation, pain threshold, narcotrend index
What is being measured
The primary outcome is the main question the study is designed to answer.
Rangeability of pressure pain threshold
According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics
Measured: 8 months
Secondary outcomes (3)
Rangeability of Narcotrend index
According to the measurement of Narcotrend index before and after intravenous injection of opioid analgesics
Measured: 8 months
Rangeability of Ramsay Sedation Scale
According to the investigation of Ramsay Sedation Scale before and after intravenous injection of opioid analgesics
Measured: 8 months
Rangeability of respiratory frequency
According to the measurement of respiratory frequency before and after intravenous injection of opioid analgesics
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianwei Zhang, Huazhong University of Science and Technology
- Investigators
- Zhang Xianwei, MD, Study director, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868152
- Sponsor's protocol ID
- Predictive opioid
- Status last verified
- Mar 2016
- First submitted
- 30 May 2013
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prediction of Opioid Analgesic
- ClinicalTrials.gov ID
- NCT01868152
- Acronym / sponsor ID
- Predictive opioid
- Conditions
- Surgery, Individuality
- Keywords
- sufentanil, individual variation, pain threshold, narcotrend index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese female patients receiving elective surgery under general anesthesia
Key inclusion criteria (4 listed)
- Aged 20-65 years
- Anesthesiologists (ASA) physical status I or II;
- Within ±20% of ideal body weight;
- Agreed to participate the research
Key exclusion criteria (7 listed)
- Psychiatric diseases;
- Diabetes mellitus;
- Severe cardiovascular diseases;
- Kidney or liver diseases;
- Alcohol or drug abuse (according to the criteria of DSM-IV);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rangeability of pressure pain threshold
Time frame: 8 months
According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics
3 secondary outcomes
Rangeability of Narcotrend index
Time frame: 8 months
Rangeability of Ramsay Sedation Scale
Time frame: 8 months
Rangeability of respiratory frequency
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Xianwei, MD study director
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Individuality, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rangeability of pressure pain threshold (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.