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

NCT03096730 | Completed Results DMC

• 1 other identifier: GWang003
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Anesthesia

Keywords

Remifentanil; Opioid-induced hyperalgesia; Postoperative pain; pain intensity

Outcome Measures

Primary Outcomes (1)

• Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm

  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

  24 hours after surgery

Secondary Outcomes (5)

• Normalized Area of Hyperalgesia Around the Incision

  1hours,3hours，6hours，12hours，24hours after surgery

• Pain Score (Numerical Rating Scale)

  1hours,3hours，6hours，12hours，24hours after surgery

• Time of First Postoperative Analgesic Requirement

  postoperative 1 hours

• Cumulative Sufentanyl Consumption

  1hours,3hours，6hours，12hours，24hours after surgery

• Occurrence of Side Effects

  24 hours

Study Arms (5)

Normal Saline

PLACEBO COMPARATOR

Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil

Drug: Normal saline; Drug: Remifentanil

Sufentanil

SHAM COMPARATOR

Normal saline is intravenously admistrated before anesthesia induction and intraoperative pain management was with sufentanil

Drug: Normal saline; Drug: Sufentanil

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine is intravenously administrated at a dose of 0.5ug/kg 10min before anesthesia induction and intraoperative pain management was with remifentanil

Drug: Remifentanil; Drug: Dexmedetomidine injection

Nalmefene

ACTIVE COMPARATOR

Nalmefene is intravenously administrated at a dose of 0.2ug/kg before anesthesia induction and intraoperative pain management was with remifentanil

Drug: Remifentanil; Drug: Nalmefene

Dexmedetomidine-Nalmefene

ACTIVE COMPARATOR

A dose of 0.1ug/kg nalmefene and a dose of 0.25ug/kg dexmedetomidine for 10 minutes before anesthesia induction and intraoperative pain management was with remifentanil

Drug: Remifentanil; Drug: Dexmedetomidine injection; Drug: Nalmefene

Interventions

Normal saline DRUG

Normal saline is intravenously administrated before anesthesia induction

Also known as: 0. 9% Sodium Chloride Injection

Normal Saline; Sufentanil

Remifentanil DRUG

Remifentanil is intravenously administrated

Also known as: Remifentanil Hydrochloride for Injection

Dexmedetomidine; Dexmedetomidine-Nalmefene; Nalmefene; Normal Saline

Sufentanil DRUG

Sufentanil is intravenously administrated

Also known as: Sufentanil injection

Sufentanil

Dexmedetomidine injection DRUG

Dexmedetomidine is intravenously administrated before anesthesia induction

Also known as: Dexmedetomidine

Dexmedetomidine; Dexmedetomidine-Nalmefene

Nalmefene DRUG

Nalmefene is intravenously administrated before anesthesia induction

Dexmedetomidine-Nalmefene; Nalmefene

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Saline Solution; Sodium Chloride; Remifentanil; Injections; Sufentanil; Dexmedetomidine; nalmefene

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Fentanyl; Imidazoles; Azoles

Results Point of Contact

• Title: Dr. Guolin Wang
• Organization: Tianjin Medical University General Hospita

1464322162@qq.com

13002211205

Study Officials

• Wang Guolin, MD

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 30, 2017
• Study Start: February 6, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 30, 2017
• Last Updated: August 3, 2021
• Results First Posted: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)