The Effects of Dexmedetomidine and Remifentanil on Carotid Patients

NCT00335972 | Terminated Phase 4 Results DMC

• 1 other identifier: 10-27-05
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

We propose to test whether intraoperative administration of dexmedetomidine will reduce hemodynamic control in the intra- and post-operative periods and reduces PACU analgesic requirements in patients undergoing carotid endarterectomy.

Conditions

Carotid Artery Stenosis

Keywords

Carotid Endarterectomy patients

Outcome Measures

Primary Outcomes (3)

• Mean Arterial Pressure

  mean arterial pressure at 15, 30, 45, 60, and 90 minutes after extubation

• Visual Analogue Scale (VAS) Pain Score

  Using a ruler, the score is determined by measuring the distance on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. 0 = no pain and 10 = worst

  pain score measured at 15, 30, 45, 60, and 90 minutes after extubation

• Intravenous Morphine Equivalents During Post-anesthesia Care Unit (PACU) After Surgery

  intravenous morphine equivalents (mg)

  During Post-anesthesia care unit after surgery,an average of 4 hours

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Drug: Remifentanil

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Drug: Dexmedetomidine

Interventions

Remifentanil DRUG

Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Remifentanil

Dexmedetomidine DRUG

Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Dexmedetomidine

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting adult patients (age \>50 years) undergoing carotid endarterectomy with general anesthesia.

You may not qualify if:

• Receiving another alpha 2-adrenoreceptor agonist;
• Contraindication to dexmedetomidine, including allergy;
• Current hepatic disease (liver function tests \> twice upper limit of normal);
• Renal insufficiency, as defined by a creatinine \> 2.0 mg/dL;
• Mentally impairment, including dementia or delirium;
• Heart block ;
• Sick sinus syndrome;
• Atrial fibrillation with a low ventricular response (\< 50 bpm);
• Absolute or relative hypovolemia;
• Prior stroke;
• Severe left-ventricular dysfunction

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Remifentanil; Dexmedetomidine

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Results Point of Contact

• Title: Rafi Avitsian, M.D
• Organization: Cleveland Clinic

avitsir@ccf.org

(216)-444-9735

Study Officials

• Ehab Farag, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2006
• First Posted: June 12, 2006
• Study Start: June 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 11, 2017
• Results First Posted: August 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)