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Dexmedetomidine Versus Magnesium Sulphate in Patients Undergoing Craniotomy for Deeply Settled Intracranial Tumours

Primary Purpose

Brain Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Magnesium sulfate
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I and II. Age more than 18 years old. supine Position Patient undergoing craniotomy for deeply settled brain tumours. Exclusion Criteria: American Society of Anesthesiologists (ASA) physical status III or more and patients with GCS < 13 Other positions (prone position, lateral position) Superficial brain tumors.

Sites / Locations

  • Faculty of Medicine, Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A: Dexmedetomidine

B: Magnesium sulphate

Arm Description

Brain tumor excision under general anesthesia. This group will receive dexmedetomidine loading 1 microgram/kg bolus in 10 minutes followed by 0.2-1 microgram/kg/hour till the end of surgery.

Brain tumor excision under general anesthesia. This group will receive a 2 gm magnesium infusion for 30 minutes.

Outcomes

Primary Outcome Measures

Change in brain relaxation score
On dural opening, brain relaxation score will be assessed which is a four points score 1. relaxed, 2. satisfactory, 3. firm, 4. Bulging

Secondary Outcome Measures

Full Information

First Posted
November 26, 2022
Last Updated
February 22, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05743725
Brief Title
Dexmedetomidine Versus Magnesium Sulphate in Patients Undergoing Craniotomy for Deeply Settled Intracranial Tumours
Official Title
Dexmedetomidine Versus Magnesium Sulphate in Patients Undergoing Craniotomy for Deeply Settled Intracranial Tumours
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
An intracranial tumor, is an abnormal mass of tissue in which cells grow and multiply uncontrollably, seemingly unchecked by the mechanisms that control normal cells. More than 150 different brain tumors have been documented, but the two main groups of brain tumors are termed primary and metastatic. Primary brain tumors include tumors that originate from the tissues of the brain or the brain's immediate surroundings. Metastatic brain tumors include tumors that arise elsewhere in the body (such as the breast or lungs) and migrate to the brain, usually through the bloodstream Barbiturates, Thiopental and pentobarbital decrease CBF, cerebral blood volume (CBV), and ICP. The reduction in ICP with these drugs is related to the reduction in CBF and CBV coupled with metabolic depression. These drugs will also have these effects in patients who have impaired CO2 response. Etomidate, as with barbiturates, etomidate reduces CBF, CMRo2, and ICP. Systemic hypotension occurs less frequently than with barbiturates. Prolonged use of etomidate may suppress the adrenocortical response to stress. Dexmedetomidine as an anesthetic adjuvant improved hemodynamic stability and decreased anesthetic requirements in patients undergoing resection for brain tumors. In addition, DEX provided better surgical field exposure conditions and early recovery from anesthesia. Narcotics, in clinical doses, narcotics produce a minimal to moderate decrease in CBF and CMRo2. When ventilation is adequately maintained, narcotics probably have minimal effects on ICP. Despite its small ICP-elevating effect, fentanyl provides satisfactory analgesia and permits the use of lower concentrations of inhalational anaesthetics
Detailed Description
Anesthetic management: Peripheral i.v line will be inserted and 2-3 mg midazolam is given. A pre-induction radial arterial line is inserted with the aid of infiltration of 2 ml lidocaine 2%. Invasive arterial blood pressure monitoring is started and pulse oximetry, 5-leads ECG, and NIBP are attached to the patient and mindray ipm-12 monitor is used. Anesthetic induction started with propofol 1-2 mg/kg, lidocaine 1 mg/kg, cis-atracurium 0.2 mg/kg and fentanyl 1-2 microgram/kg. Intubation is done with cuffed endotracheal tube and tidal volume and respiratory rate are set to achieve end-tidal Co2 of 30-28 mmHg. Esophageal temperature probe and urinary catheter are put in place. Patients then will receive maintenance of anesthesia with isoflurane < 1 MAC, propofol 10-60 microgram/kg/min, and cis-atracurium 2-3 microgram/kg/minute. Patients are then grouped into two groups: Group A: will receive dexmedetomidine loading 1 microgram/kg bolus in 10 minutes followed by 0.2-1 microgram/kg/hour till the end of surgery. Group B: will receive 2 gm magnesium infusion for 30 minutes. All Patients will receive mannitol 20% 0.5-1 gm/kg and dexamethasone 8mg and paracetamol 1gm near the end of surgery. Patients will receive their fasting requirements of normal saline in the first 3 hours of surgery. Maintenance fluid used will be ringer acetate and will be given according to pulse pressure variation index (PPVI) that is derived from pulse contour analysis of invasive arterial blood pressure waveform. Patients will be given ringer acetate when PPVI is > 12%. If hypotension occurred without change in PPVI targets, it will be treated with 10 mg ephedrine. On dural opening, brain relaxation score will be assessed which is a four points score 1. relaxed, 2. satisfactory, 3. firm, 4. Bulging. Arterial blood gas samples will be collected at induction and at the end of surgery. After removal of cranial fixation pins, anesthesia is discontinued and reversal of muscle relaxant is done with atropine 0.5 mg and neostigmine 0.05 mg/kg then extubation is done and patient is transferred to the ICU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Brain tumor excision under general anesthesia. This group will receive dexmedetomidine loading 1 microgram/kg bolus in 10 minutes followed by 0.2-1 microgram/kg/hour till the end of surgery.
Arm Title
B: Magnesium sulphate
Arm Type
Active Comparator
Arm Description
Brain tumor excision under general anesthesia. This group will receive a 2 gm magnesium infusion for 30 minutes.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
dexmedetomidine loading 1 microgram/kg bolus in 10 minutes followed by 0.2-1 microgram/kg/hour till the end of surgery
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
2 gm magnesium infusion for 30 minutes
Primary Outcome Measure Information:
Title
Change in brain relaxation score
Description
On dural opening, brain relaxation score will be assessed which is a four points score 1. relaxed, 2. satisfactory, 3. firm, 4. Bulging
Time Frame
assessed by the neurosurgeon with dural opening, after 2 hours and before dural closure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I and II. Age more than 18 years old. supine Position Patient undergoing craniotomy for deeply settled brain tumours. Exclusion Criteria: American Society of Anesthesiologists (ASA) physical status III or more and patients with GCS < 13 Other positions (prone position, lateral position) Superficial brain tumors.
Facility Information:
Facility Name
Faculty of Medicine, Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibraheem Abdelmageed
Phone
+201142429670
Email
dr.ibraheemembaby@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dexmedetomidine Versus Magnesium Sulphate in Patients Undergoing Craniotomy for Deeply Settled Intracranial Tumours

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