Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335972
Status:
TERMINATED
Last Update Posted:
2017-08-11
First Post:
2006-06-08
Brief Title:
The Effects of Dexmedetomidine and Remifentanil on Carotid Patients
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Phase 4 The Effects of Dexmedetomidine and Remifentanil on Postoperative Hemodynamics and PainOpioids in Patients Undergoing Carotid Endarterectomy
Status:
TERMINATED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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 32 min even after prolonged infusion4 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 apnea1617 and hyperalgesia18 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 1112 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 1314 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
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 apnea1617 and hyperalgesia18 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 1112 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 1314 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None