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

Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01748071
Enrollment
120
Registered
2012-12-12
Start date
2012-06-30
Completion date
2013-02-28
Last updated
2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individuality, Surgery

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Pressure Pain Threshold10 minutes after the procedureAccording to the measurement of pressure pain threshold after intravenous injection of opioid analgesics
Mean Value of Narco-trend Index10 minutes after the procedureAccording 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.

Secondary

MeasureTime frameDescription
Mean Arterial Pressure10 minutes after the procedureAccording to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics
Mean Heart Rate10 minutes after the procedureAccording to the measurement of heart rate before and after intravenous injection of opioid analgesics
Mean Respiratory Frequency10 minutes after the procedureAccording to the measurement of respiratory frequency after intravenous injection of opioid analgesics

Countries

China

Participant flow

Participants by arm

ArmCount
Sufentanil Group
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
40
Fentanyl Group
Grouped by intravenous injection of fentanyl at the time of anesthesia induction
40
Saline Group
Grouped by intravenous injection of saline before the time of anesthesia induction
40
Total120

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event220

Baseline characteristics

CharacteristicFentanyl GroupSaline GroupSufentanil GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
40 Participants40 Participants40 Participants120 Participants
Age Continuous47 years
STANDARD_DEVIATION 13
49 years
STANDARD_DEVIATION 11
49 years
STANDARD_DEVIATION 12
48 years
STANDARD_DEVIATION 13
Region of Enrollment
China
40 participants40 participants40 participants120 participants
Sex: Female, Male
Female
40 Participants40 Participants40 Participants120 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 380 / 380 / 40
serious
Total, serious adverse events
0 / 380 / 380 / 40

Outcome results

Primary

Mean Pressure Pain Threshold

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

Time frame: 10 minutes after the procedure

ArmMeasureValue (MEAN)Dispersion
Sufentanil GroupMean Pressure Pain Threshold9.93 kg/cm2Standard Deviation 3.5
Fentanyl GroupMean Pressure Pain Threshold6.20 kg/cm2Standard Deviation 3
Saline GroupMean Pressure Pain Threshold2.36 kg/cm2Standard Deviation 0.97
Primary

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.

Time frame: 10 minutes after the procedure

ArmMeasureValue (MEAN)Dispersion
Sufentanil GroupMean Value of Narco-trend Index50.9 units on a scaleStandard Deviation 18.3
Fentanyl GroupMean Value of Narco-trend Index70.4 units on a scaleStandard Deviation 27.3
Saline GroupMean Value of Narco-trend Index93.7 units on a scaleStandard Deviation 11.8
Secondary

Mean Arterial Pressure

According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics

Time frame: 10 minutes after the procedure

ArmMeasureValue (MEAN)Dispersion
Sufentanil GroupMean Arterial Pressure90.1 mmHgStandard Deviation 9.7
Fentanyl GroupMean Arterial Pressure89.7 mmHgStandard Deviation 12.8
Saline GroupMean Arterial Pressure90.3 mmHgStandard Deviation 14
Secondary

Mean Heart Rate

According to the measurement of heart rate before and after intravenous injection of opioid analgesics

Time frame: 10 minutes after the procedure

ArmMeasureValue (MEAN)Dispersion
Sufentanil GroupMean Heart Rate77.9 beats per minuteStandard Deviation 10.1
Fentanyl GroupMean Heart Rate74.4 beats per minuteStandard Deviation 12.9
Saline GroupMean Heart Rate77.6 beats per minuteStandard Deviation 13.9
Secondary

Mean Respiratory Frequency

According to the measurement of respiratory frequency after intravenous injection of opioid analgesics

Time frame: 10 minutes after the procedure

ArmMeasureValue (MEAN)Dispersion
Sufentanil GroupMean Respiratory Frequency13.9 breaths per minuteStandard Deviation 3.3
Fentanyl GroupMean Respiratory Frequency12.3 breaths per minuteStandard Deviation 2.2
Saline GroupMean Respiratory Frequency16.1 breaths per minuteStandard Deviation 3.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026