The Effects of Dexmedetomidine and Remifentanil on Carotid Patients

Carotid Artery Stenosis Clinical Trial

Official title:

Phase 4: The Effects of Dexmedetomidine and Remifentanil on Postoperative Hemodynamics and Pain/Opioids in Patients Undergoing Carotid Endarterectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00335972
• Other study ID #: 10-27-05
• Status: Terminated
• Phase: Phase 4
• First received: June 8, 2006
• Last updated: August 9, 2017
• Start date: June 2006
• Est. completion date: May 2008

Study information

• Verified date: August 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Remifentanil is an amidopiperidine derivative with unique pharmacokinetic properties. Its steady-state volume of distribution is 30 L (3). Its context-sensitive half life is consistently short (3.2 min), even after prolonged infusion(4). The pharmacokinetic profile of remifentanil is independent of the hepatic (5) and renal function (6). And finally, the recovery profile of remifentanil is excellent with a speedy anesthetic emergence time which is important for a quick and proper neurologic assessment in the early postoperative period.

Remifentanil produces good intraoperative hemodynamic control during intense noxious stimulation like laryngoscopy, endotracheal intubation, and during pinning of the head (8). However, side effects of remifentanil include hypotension and bradycardia (15) intraoperatively, along with apnea(16,17) and hyperalgesia(18) postoperatively which is caused by increasing sensitivity to noxious stimuli. Investigations demonstrate different mechanisms of opioid-induced post-infusion anti-analgesia and secondary hyperalgesia (9). Overall remifentanil is a versatile opioid that is being increasingly used in the operating room.

DEXMEDETOMIDINE (DEX), an alpha-2 adrenoreceptor agonist, is gaining popularity in neuroanesthesia. It has a desirable neurophysiologic profile including neuroprotective characteristics through its effect on α2A receptor subtypes (10). Its hypnotic effect is mediated through the α2 receptors in the locus ceruleus and its analgesic properties are mediated through an effect on the dorsal horn of the spinal cord (11,12). Since it has sympatholytic and antinociceptive properties, it may improve hemodynamic stability at critical moments of neurosurgical stimulation. Dexmedetomidine reduces anesthetic drug and opioid requirements in the perioperative period (13,14). In addition, dexmedetomidine does not affect evoked potential monitoring, (19) making it a favorable anesthetic adjunct in cases in which neurophysiologic monitoring is being used. In recent years, dexmedetomidine has emerged as an effective drug useful in a wide range of anesthesia related areas.

Study Questions We postulate that dexmedetomidine provides better hemodynamic control in the intra- and post-operative periods and reduces PACU analgesic requirements.

Primary Hypothesis 1: Intraoperative dexmedetomidine provides better postoperative analgesia than remifentanil, thus reducing PACU opioid requirements.

Primary Hypothesis 2: Dexmedetomidine causes fewer hemodynamic perturbations than remifentanil.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Drug:
• Remifentanil
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
• Dexmedetomidine
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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Arterial Pressure		mean arterial pressure at 15, 30, 45, 60, and 90 minutes after extubation
Primary	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
Primary	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