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

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

Study Overview

• Status: Unknown
• Conditions: Skull Pin Insertion
• Intervention / Treatment: Other: normal saline 0.9%; Drug: Dexmedetomidine Injection [Precedex]

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ghada Mohammed Abo Elfadl, M.D; Phone Number: 01005802086; Email: ghadafadl77@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut governorate
    • Contact: Ghada M Aboelfadl, MD; Phone Number: 01005802086; Email: ghadafadl77@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: group I (placebo); will receive intravenous normal saline (NS)	Other: normal saline 0.9%; will receive intravenous normal saline 0.9%
Experimental: group II (Dex 0.5); will receive intravenous Dex 0.5 mcg/kg	Drug: Dexmedetomidine Injection [Precedex]; will receive intravenous Dexmedetomidine; Other Names: Dexmedetomidine
Experimental: group III (Dex 0.25); will receive intravenous Dex 0.25 mcg/kg	Drug: Dexmedetomidine Injection [Precedex]; will receive intravenous Dexmedetomidine; Other Names: Dexmedetomidine
Experimental: group IV (Dex 0.2); will receive intravenous Dex 0.2 mcg/kg.	Drug: Dexmedetomidine Injection [Precedex]; will receive intravenous Dexmedetomidine; Other Names: Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial blood pressure change	systolic and diastolic blood pressure mmhg	before Skull Pin Insertion till 20 minutes
heart rate change	heart rate beat/minute	before Skull Pin Insertion till 20 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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. doi: 10.1097/00000539-199706000-00022.
• 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. doi: 10.1111/j.1399-6576.1989.tb02907.x.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 16, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Skull Pin Insertion; Hemodynamic Responses
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 17300238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No