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

Skull Pin Insertion Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03738059
• Other study ID #: 17300238
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 15, 2018
• Est. completion date: March 2019

Study information

• Verified date: December 2018
• Source: Assiut University
• Contact: Ghada Mohammed Abo Elfadl, M.D
• Phone: 01005802086
• Email: ghadafadl77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Skull Pin Insertion

Intervention

Drug:
• Dexmedetomidine Injection [Precedex]
will receive intravenous Dexmedetomidine

Other:
• normal saline 0.9%
will receive intravenous normal saline 0.9%

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Bharne S, Bidkar PU, Badhe AS, Parida S, Ramesh AS. Comparison of intravenous labetalol and bupivacaine scalp block on the hemodynamic and entropy changes following skull pin application: A randomized, open label clinical trial. Asian J Neurosurg. 2016 Jan-Mar;11(1):60-5. doi: 10.4103/1793-5482.165801. — View Citation

Geze S, Yilmaz AA, Tuzuner F. The effect of scalp block and local infiltration on the haemodynamic and stress response to skull-pin placement for craniotomy. Eur J Anaesthesiol. 2009 Apr;26(4):298-303. doi: 10.1097/EJA.0b013e32831aedb2. — View Citation

Jamali S, Archer D, Ravussin P, Bonnafous M, David P, Ecoffey C. The effect of skull-pin insertion on cerebrospinal fluid pressure and cerebral perfusion pressure: influence of sufentanil and fentanyl. Anesth Analg. 1997 Jun;84(6):1292-6. — View Citation

Levin R, Hesselvik JF, Kourtopoulos H, Vavruch L. Local anesthesia prevents hypertension following application of the Mayfield skull-pin head holder. Acta Anaesthesiol Scand. 1989 May;33(4):277-9. — View Citation

Nagappa S, Kalappa S, Sridhara RB. Evaluation of the Hemodynamic Response of Intravenous Clonidine versus Ropivacaine Scalp Block to Insertion of Scalp Pins in Neurosurgical Patients. Anesth Essays Res. 2018 Jan-Mar;12(1):213-217. doi: 10.4103/0259-1162.194572. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial blood pressure change	systolic and diastolic blood pressure mmhg	before Skull Pin Insertion till 20 minutes
Primary	heart rate change	heart rate beat/minute	before Skull Pin Insertion till 20 minutes