N/A
Completed N=150
Effect of Dexmedetomidine Combined With Low-dose Nalmefene on Preventing Remifentanil-induced Postoperative Hyperalgesia
Source: ClinicalTrials.gov NCT03096730 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm — 61.5; 88.2; 73.0; 67.2 g
Summary
To explore and compare antihyperalgesic effects of Dexmedetomidine,Nalmefene,and a combination of both received before anesthesia induction.
To evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm |
61.5; 88.2; 73.0; 67.2; 74.0 | — |
| SECONDARY Normalized Area of Hyperalgesia Around the Incision |
— | — |
| SECONDARY Pain Score (Numerical Rating Scale) |
— | — |
| SECONDARY Time of First Postoperative Analgesic Requirement |
— | — |
| SECONDARY Cumulative Sufentanyl Consumption |
— | — |
| SECONDARY Occurrence of Side Effects |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients are scheduled to undergo Gynecological surgery under a short general anesthesia of 1-3 hours.
- American Society of Anesthesiologists physical status is I-II.
- Written informed consent was obtained from all the subjects.
Exclusion Criteria
- Subject has a diagnosis of Coronary heart disease, bronchial asthma, cardiac, lung, hepatic and renal insufficiency.
- Subject has a diagnosis of Severe high blood pressure , diabetes, obesity (BMI>30).
- Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 h before surgery.
- .Subject has Pregnancy, psychiatric disease.
- Subject has any contraindication for the use of patient-controlled analgesia (PCA).
- Inability to understand the Study Information Sheet and provide a written consent to take part in the study.
Data sourced from ClinicalTrials.gov (NCT03096730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.