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

NCT05743725 | Unknown

• 1 other identifier: master 2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

• 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

  assessed by the neurosurgeon with dural opening, after 2 hours and before dural closure

Study Arms (2)

A: Dexmedetomidine

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine

B: Magnesium sulphate

ACTIVE COMPARATOR

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

Drug: Magnesium sulfate

Interventions

Dexmedetomidine DRUG

dexmedetomidine loading 1 microgram/kg bolus in 10 minutes followed by 0.2-1 microgram/kg/hour till the end of surgery

A: Dexmedetomidine

Magnesium sulfate DRUG

2 gm magnesium infusion for 30 minutes

B: Magnesium sulphate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• American Society of Anesthesiologists (ASA) physical status III or more and patients with GCS \< 13
• Other positions (prone position, lateral position)
• Superficial brain tumors.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Dexmedetomidine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Ibraheem Abdelmageed, lecturer of anaesthesia and intensive care at Assiut university

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: February 24, 2023
• Study Start: March 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: February 15, 2024
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)