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

Assiut University

Status and phase: Unknown; Early Phase 1

Conditions: Skull Pin Insertion

Treatments: Other: normal saline 0.9%; Drug: Dexmedetomidine Injection [Precedex]

Study type: Interventional

Funder types: Other

Identifiers

NCT03738059

17300238

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

group I (placebo)

Placebo Comparator group

Description:

will receive intravenous normal saline (NS)

Treatment:

Other: normal saline 0.9%

group II (Dex 0.5)

Experimental group

Description:

will receive intravenous Dex 0.5 mcg/kg

Treatment:

Drug: Dexmedetomidine Injection [Precedex]

group III (Dex 0.25)

Experimental group

Description:

will receive intravenous Dex 0.25 mcg/kg

Treatment:

Drug: Dexmedetomidine Injection [Precedex]

group IV (Dex 0.2)

Experimental group

Description:

will receive intravenous Dex 0.2 mcg/kg.

Treatment:

Drug: Dexmedetomidine Injection [Precedex]