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

NCT ID: NCT03738059

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2019-03-31

Brief Summary

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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

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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.

Conditions

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Skull Pin Insertion

Keywords

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Skull Pin Insertion Dexmedetomidine Hemodynamic Responses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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group I (placebo)

will receive intravenous normal saline (NS)

Group Type PLACEBO_COMPARATOR

normal saline 0.9%

Intervention Type OTHER

will receive intravenous normal saline 0.9%

group II (Dex 0.5)

will receive intravenous Dex 0.5 mcg/kg

Group Type EXPERIMENTAL

Dexmedetomidine Injection [Precedex]

Intervention Type DRUG

will receive intravenous Dexmedetomidine

group III (Dex 0.25)

will receive intravenous Dex 0.25 mcg/kg

Group Type EXPERIMENTAL

Dexmedetomidine Injection [Precedex]

Intervention Type DRUG

will receive intravenous Dexmedetomidine

group IV (Dex 0.2)

will receive intravenous Dex 0.2 mcg/kg.

Group Type EXPERIMENTAL

Dexmedetomidine Injection [Precedex]

Intervention Type DRUG

will receive intravenous Dexmedetomidine

Interventions

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Dexmedetomidine Injection [Precedex]

will receive intravenous Dexmedetomidine

Intervention Type DRUG

normal saline 0.9%

will receive intravenous normal saline 0.9%

Intervention Type OTHER

Other Intervention Names

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Dexmedetomidine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed AboelFadl

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut governorate

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ghada Mohammed Abo Elfadl, M.D

Role: CONTACT

Phone: 01005802086

Email: [email protected]

Facility Contacts

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Ghada M Aboelfadl, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19262392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29628584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26889282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9174309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2655365 (View on PubMed)

Other Identifiers

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17300238

Identifier Type: -

Identifier Source: org_study_id