Magnesium Sulphate Versus Fentanyl Sedation During Burr-hole Surgery

NCT03854812 | Completed Phase 2

• 1 other identifier: N28-2018
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

MgSO4 was found to reduce the perioperative anesthetic and analgesic requirements when used as an adjuvant to general anesthesia. Fentanyl is a potent opioid and used as adjuvant to other sedatives in awake craniotomy procedure. No study, to the best of our knowledge had evaluated fentanyl continuous infusion, nor MgSo4 infusion as adjuvant sedative agents to propofol during Burr-hole surgery. The aim of this study is to evaluate and compare MgSO4 versus fentanyl continuous infusions for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural hematoma with local infiltration.

Conditions

Monitored Anesthesia Care

Keywords

magnesium sulphate; fentanyl; propofol; monitored anesthesia care; burr-hole evacuation; chronic subdural hematoma

Outcome Measures

Primary Outcomes (1)

• average systolic blood pressure

  mmgh

  after induction of conscious sedation till end of procedure

Secondary Outcomes (12)

• ephedrine use

  after induction of conscious sedation till end of procedure

• Total amount of Propofol consumption

  after induction of conscious sedation till end of procedure

• Total number of intraoperative patient's movements

  after induction of conscious sedation till end of procedure

• Systolic blood pressure

  upon arrival at the operating room, after induction of conscious sedation, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival at PACU, 5,10,15,30 min and 1 hour at the PACU

• Diastolic blood pressure

  upon arrival at the operating room, after induction of conscious sedation, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival at PACU, 5,10,15,30 min and 1 hour at the PACU

Study Arms (2)

Group M

ACTIVE COMPARATOR

magnesium sulphate as adjuvant to propofol

Drug: Magnesium Sulphate; Drug: Propofol

Group F

ACTIVE COMPARATOR

fentanyl as adjuvant to propofol

Drug: Fentanyl; Drug: Propofol

Interventions

Magnesium Sulphate DRUG

a loading of 50 mg/kg in 15 minutes of Magnesium sulphate, and will be followed by continuous infusion at 1 ml/kg/h of 15 mg/ml solution

Also known as: magnesium sulfate

Group M

Fentanyl DRUG

loading of 1 mcg/kg in over 15 minutes of fentanyl then will receive continuous infusion starting at 1 ml /kg/h. of 0.5 mcg/ml solution

Group F

Propofol DRUG

0.5-1.5 mg/kg bolus of propofol over 10 minutes to achieve target Ramsay sedation scale (RSS) of 3 (respond to command), if RSS afterwards does not reach 3 a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, and will be followed by 1-2.5 mg/kg/hr infusion to maintain Intraoperative BIS readings between 60 - 80

Group F; Group M

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with unilateral, chronic subdural hematoma,
• aged above 50 years,
• american society of anesthesiologist-physical status (ASA-PS) grade I-II,
• Glasgow coma scale of 14-15.

You may not qualify if:

• Patients with hypertension (Systolic blood pressure \> 160 mmHg),
• bradycardia (\<50 bpm),
• ischemic heart disease,
• second- or third-degree heart block,
• long-term abuse of or addiction to opioids, and sedative-hypnotic drugs (\>6 months),
• allergy to study drugs
• neuropsychiatric diseases
• patients with predicted difficult airway
• patients with history of obstructive sleep apnea
• patients with deviation in the surgical technique
• inadequacy of local anesthesia

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

Location

Related Publications (3)

• Rodriguez-Rubio L, Nava E, Del Pozo JSG, Jordan J. Influence of the perioperative administration of magnesium sulfate on the total dose of anesthetics during general anesthesia. A systematic review and meta-analysis. J Clin Anesth. 2017 Jun;39:129-138. doi: 10.1016/j.jclinane.2017.03.038. Epub 2017 Apr 7.

  PMID: 28494889 BACKGROUND

• Sinha PK, Koshy T, Gayatri P, Smitha V, Abraham M, Rathod RC. Anesthesia for awake craniotomy: a retrospective study. Neurol India. 2007 Oct-Dec;55(4):376-81. doi: 10.4103/0028-3886.33308.

  PMID: 18040111 BACKGROUND

• Gignac E, Manninen PH, Gelb AW. Comparison of fentanyl, sufentanil and alfentanil during awake craniotomy for epilepsy. Can J Anaesth. 1993 May;40(5 Pt 1):421-4. doi: 10.1007/BF03009510.

  PMID: 8513521 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Magnesium Sulfate; Fentanyl; Propofol

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Maha mostafa, MD

  kasr el aini

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, surgical intensive care and pain mangement

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: February 26, 2019
• Study Start: March 1, 2019
• Primary Completion: October 12, 2019
• Study Completion: October 12, 2019
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

EG (1)