SurgeryNCT01748071

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

An observational study of Surgery and Individuality, run by Huazhong University of Science and Technology at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 65 years, women only
Conditions the study is for: Surgery, Individuality
Type of treatment: Injection or infusion
How many people: 120 participants
Where: 1 siteChina
Study dates: Jun 2012to Feb 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: 120 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

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

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

Other trials in China

About this study

Official title: Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics

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.

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: fentanyl, sufentanil, individual variation, pain threshold, nacro-trend index

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01748071
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Pressure Pain Threshold
According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics
Measured: 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.
Measured: 10 minutes after the procedure

Secondary outcomes (3)

Mean Arterial Pressure
According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics
Measured: 10 minutes after the procedure
Mean Heart Rate
According to the measurement of heart rate before and after intravenous injection of opioid analgesics
Measured: 10 minutes after the procedure
Mean Respiratory Frequency
According to the measurement of respiratory frequency after intravenous injection of opioid analgesics
Measured: 10 minutes after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Feb 2013

First posted12 Dec 2012 (estimated)
Study startJun 2012
Primary completionDec 2012
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Case-control
Time perspective: Prospective
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01748071
Sponsor's protocol ID: Individual Variation
Status last verified: Sep 2013
First submitted: 9 Dec 2012
Last updated: 25 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics
ClinicalTrials.gov ID: NCT01748071
Acronym / sponsor ID: Individual Variation
Conditions: Surgery, Individuality
Keywords: fentanyl, sufentanil, individual variation, pain threshold, nacro-trend index
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Huazhong University of Science and TechnologyUniversity, hospital or other
Study start: Jun 2012
Primary completion: Dec 2012 (actual)
Study completion: Feb 2013 (actual)
First posted: 12 Dec 2012 (estimated)
Results: Posted 25 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 20 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 120 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 (8 listed)

History of chronic pain;
Psychiatric diseases;
Diabetes mellitus;
Severe cardiovascular diseases;
Kidney or liver diseases;

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

Mean Pressure Pain Threshold
Time frame: 10 minutes after the procedure
According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics
Mean Value of Narco-trend Index
Time frame: 10 minutes after the procedure
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.

3 secondary outcomes

Mean Arterial Pressure
Time frame: 10 minutes after the procedure
Mean Heart Rate
Time frame: 10 minutes after the procedure
Mean Respiratory Frequency
Time frame: 10 minutes after the procedure

Results and safety

Results posted to the registry on 25 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sufentanil Group	40	38
Fentanyl Group	40	38
Saline Group	40	40

Primary outcome: Mean Pressure Pain Threshold

Time frame: 10 minutes after the procedure. Mean (Standard Deviation). Unit: kg/cm2

Measure	Sufentanil Group n = 38	Fentanyl Group n = 38	Saline Group n = 40
Value	9.93 (3.50)	6.20 (3.00)	2.36 (0.97)

Primary outcome: Mean Value of Narco-trend Index

Time frame: 10 minutes after the procedure. Mean (Standard Deviation). Unit: units on a scale

Measure	Sufentanil Group n = 38	Fentanyl Group n = 38	Saline Group n = 40
Value	50.9 (18.3)	70.4 (27.3)	93.7 (11.8)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sufentanil Group	0 of 38 (0%)	0 of 38 (0%)	Not reported
Fentanyl Group	0 of 38 (0%)	0 of 38 (0%)	Not reported
Saline Group	0 of 40 (0%)	0 of 40 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
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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 8 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 25 Nov 2013. 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?

Yes. Results are posted in the registry (first posted 25 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Pressure Pain Threshold (time frame: 10 minutes after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01748071.

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 25 Nov 2013.