Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 3:09 AM
Study NCT ID:
NCT03738059
Status:
UNKNOWN
Last Update Posted:
2018-12-19
First Post:
2018-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Lowest Effective Dose of Dexmedetomidine in Attenuating the Hemodynamic Responses During Skull Pin Insertion in Patients Undergoing Elective Craniotomy
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Assessment of the Lowest Effective Dose of Dexmedetomidine in Attenuating the Hemodynamic Responses During Skull Pin Insertion in Patients Undergoing Elective Craniotomy: Randomized Control Study
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Skull pins are used to immobilize the head during craniotomy. Fixation of skull pins causes acute hemodynamic changes which may affect cerebral autoregulation and hence cerebral blood flow. Therefore, maintenance of stable hemodynamic parameters during skull pin placement under general anesthesia is crucial to ensure adequate cerebral perfusion and prevention of acute rise of intracranial pressure
Detailed Description:
Many different strategies have been used to minimize the hemodynamic responses to skull pin placement with varying results. Local anesthetic infiltration at pin application sites has been used but was always unsuccessful in obtunding the hemodynamic responses to skull pin placement. Dexmedetomidine, an alpha-2 adrenoceptor agonist, has been recently introduced as a sedative for patients on mechanical ventilation. In addition to its sedative effect; Dexmedetomidine has significant analgesic qualities and has been labeled as "analgesia-sparing". To the best of the investigator's knowledge, few studies investigated Dex use to suppress hemodynamic responses to skull pinning. The aim of the current study was to evaluate the lowest effective dose of Dexmedetomidine in attenuating the hemodynamic responses to skull pin placement for craniotomies. Lidocaine, administered subcutaneously at the head-holder pin sites, was more effective in preventing the blood pressure response to skull-pin than was deepening the level of anesthesia.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: