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The Lowest Effective Dose of Dexmedetomidine in Attenuating the Hemodynamic Responses During Skull Pin Insertion in Patients Undergoing Elective Craniotomy

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
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03738059
Enrollment
120
Registered
2018-11-13
Start date
2018-11-15
Completion date
2019-03-31
Last updated
2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skull Pin Insertion

Keywords

Skull Pin Insertion, Dexmedetomidine, Hemodynamic Responses

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.

Interventions

DRUGDexmedetomidine Injection [Precedex]

will receive intravenous Dexmedetomidine

OTHERnormal saline 0.9%

will receive intravenous normal saline 0.9%

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 120 Adult patients, * undergoing elective craniotomy * ASA I and II patients

Exclusion criteria

* patients undergoing craniotomy for emergency surgery, * raised ICP, * obese patients (body mass index \>30 kg/m2 for males and 28 kg/m2 for females), * patients having systemic comorbidities (cardiac, renal, hepatic, and endocrinal), * hypertensive patients (including those detected after admission), * patients undergoing intracranial aneurysm clipping

Design outcomes

Primary

MeasureTime frameDescription
arterial blood pressure changebefore Skull Pin Insertion till 20 minutessystolic and diastolic blood pressure mmhg
heart rate changebefore Skull Pin Insertion till 20 minutesheart rate beat/minute

Countries

Egypt

Contacts

Primary ContactGhada Mohammed Abo Elfadl, M.D
ghadafadl77@gmail.com01005802086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026