NCT03738059

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Nov 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

November 5, 2018

Last Update Submit

December 16, 2018

Conditions

Skull Pin Insertion

Keywords

Skull Pin InsertionDexmedetomidineHemodynamic Responses

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

group I (placebo)

PLACEBO COMPARATOR

will receive intravenous normal saline (NS)

Other: normal saline 0.9%

group II (Dex 0.5)

EXPERIMENTAL

will receive intravenous Dex 0.5 mcg/kg

Drug: Dexmedetomidine Injection [Precedex]

group III (Dex 0.25)

EXPERIMENTAL

will receive intravenous Dex 0.25 mcg/kg

Drug: Dexmedetomidine Injection [Precedex]

group IV (Dex 0.2)

EXPERIMENTAL

will receive intravenous Dex 0.2 mcg/kg.

Drug: Dexmedetomidine Injection [Precedex]

Interventions

Dexmedetomidine Injection [Precedex]DRUG

will receive intravenous Dexmedetomidine

Also known as: Dexmedetomidine
group II (Dex 0.5)group III (Dex 0.25)group IV (Dex 0.2)
normal saline 0.9%OTHER

will receive intravenous normal saline 0.9%

group I (placebo)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients,
  • undergoing elective craniotomy
  • ASA I and II patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, 71515, Egypt

RECRUITING

Related Publications (5)

  • 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.

    PMID: 9174309BACKGROUND

  • 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.

    PMID: 2655365BACKGROUND

  • 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.

    PMID: 19262392BACKGROUND

  • 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.

    PMID: 29628584BACKGROUND

  • 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.

    PMID: 26889282BACKGROUND

MeSH Terms

Interventions

DexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Ghada Mohammed Abo Elfadl, M.D

CONTACT

01005802086ghadafadl77@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 13, 2018

Study Start

November 15, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

December 19, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)