Trial · NCT03096730

Effect of Dexmedetomidine Combined With Low-dose Nalmefene on Preventing Remifentanil-induced Postoperative Hyperalgesia

NCT03096730, Not applicable, Completed, Tianjin Medical University General Hospital; results first posted 2021-08-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Dexmedetomidine Combined With Low-dose Nalmefene on Preventing Remifentanil-induced Postoperative Hyperalgesia. Trials, record NCT03096730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03096730

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Dexmedetomidine Combined With Low-dose Nalmefene on Preventing Remifentanil-induced Postoperative Hyperalgesia
NCT number: NCT03096730
Status: Completed
Phases: Not applicable
Enrollment: 150 participants, actual
Lead sponsor: Tianjin Medical University General Hospital
Conditions: Pain, Anesthesia
Interventions: Normal saline, Remifentanil, Sufentanil, Dexmedetomidine injection, Nalmefene
First posted: 2017-03-30
Last updated: 2021-08-03
Results first posted: 2021-08-03

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	24 hours after surgery	The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament at 24 hours postoperatively
Secondary	Normalized Area of Hyperalgesia Around the Incision	1hours,3hours，6hours，12hours，24hours after surgery	The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.
Secondary	Pain Score (Numerical Rating Scale)	1hours,3hours，6hours，12hours，24hours after surgery	The pain score at rest was evaluated by pain 11-point numerical rating scale : 0 = no pain, 10 = greatest imaginable pain.
Secondary	Time of First Postoperative Analgesic Requirement	postoperative 1 hours	First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
Secondary	Cumulative Sufentanyl Consumption	1hours,3hours，6hours，12hours，24hours after surgery	Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving post-anaesthesia care unit . This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperatively
Secondary	Occurrence of Side Effects	24 hours	Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus，hypotention/hypertention，bradycardia/tachycardia

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	24 hours after surgery	g	MEAN
SECONDARY	Normalized Area of Hyperalgesia Around the Incision	1hours,3hours，6hours，12hours，24hours after surgery
SECONDARY	Pain Score (Numerical Rating Scale)	1hours,3hours，6hours，12hours，24hours after surgery
SECONDARY	Time of First Postoperative Analgesic Requirement	postoperative 1 hours
SECONDARY	Cumulative Sufentanyl Consumption	1hours,3hours，6hours，12hours，24hours after surgery
SECONDARY	Occurrence of Side Effects	24 hours

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	Normal Saline	61.5	Standard Deviation 6.0	g
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	Sufentanil	88.2	Standard Deviation 23.40	g
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	Dexmedetomidine	73.0	Standard Deviation 3.2	g
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	Nalmefene	67.2	Standard Deviation 3.3	g
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	Dexmedetomidine-Nalmefene	74.0	Standard Deviation 9.3	g

Source ClinicalTrials.gov

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Normal Saline	30
Overall Study	STARTED	Sufentanil	30
Overall Study	STARTED	Dexmedetomidine	30
Overall Study	STARTED	Nalmefene	30
Overall Study	STARTED	Dexmedetomidine-Nalmefene	30
Overall Study	COMPLETED	Normal Saline	27
Overall Study	COMPLETED	Sufentanil	27
Overall Study	COMPLETED	Dexmedetomidine	27
Overall Study	COMPLETED	Nalmefene	27
Overall Study	COMPLETED	Dexmedetomidine-Nalmefene	27

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals15

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Normal Saline	27
Total, all-cause mortality	Sufentanil	27
Total, all-cause mortality	Dexmedetomidine	27
Total, all-cause mortality	Nalmefene	27
Total, all-cause mortality	Dexmedetomidine-Nalmefene	27
Total, other adverse events	Normal Saline	27
Total, other adverse events	Sufentanil	27
Total, other adverse events	Dexmedetomidine	27
Total, other adverse events	Nalmefene	27
Total, other adverse events	Dexmedetomidine-Nalmefene	27

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03096730

GET https://conductscience.org/api/trials/v1/NCT03096730/registered

API reference For AI assistants