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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I and

II. 2.

Age more than 18 years old. 3. supine Position. 4. Patient undergoing craniotomy for deeply settled brain tumours.

Exclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status III or more and patients with GCS < 13. 2. Other positions (prone position, lateral position) 3. Superficial brain tumors.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05743725
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assiut University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Egypt
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: A: Dexmedetomidine

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.

Active Comparator: B: Magnesium sulphate

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

Interventions

Drug: - Dexmedetomidine

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

Drug: - Magnesium sulfate

2 gm magnesium infusion for 30 minutes

Contact a Trial Team

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International Sites

Faculty of Medicine, Assiut University, Assiut, Egypt

Status

Address

Faculty of Medicine, Assiut University

Assiut, , 71515

Site Contact

Ibraheem Abdelmageed

[email protected]

+201142429670

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