Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH

NCT03548493 | Completed Phase 2

• 1 other identifier: N-28-2018
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that magnesium sulphate owing to its analgesic and sedative properties is not inferior to fentanyl in providing conscious sedation as adjuvants to propofol and local injection of lidocaine in patients undergoing surgery for evacuation of subdural haematoma. Consequently, the investigators are testing this hypothesis by comparing the sedative and analgesic effects of magnesium sulphate versus fentanyl as adjuvants to propofol lidocaine admixture for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural haematoma.

Conditions

Conscious Sedation

Keywords

Magnesium sulphate; Fentanyl; Conscious sedation; chronic subdural haematoma; Propofol; Burr hole

Outcome Measures

Primary Outcomes (1)

• Total amount of Propofol consumption in each group

  To measure total amount of propofol consumption from induction of conscious sedation till the end of the operation and to compare it between both groups

  From the start of propofol infusion after arrival to the operating room and throughout the duration of the surgery

Secondary Outcomes (6)

• To measure the total number of intraoperative patient's movements

  From the start of the surgery and throughout the duration of the surgery

• Heart rate

  Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU

• Non invasive blood pressure

  Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU

• To assess surgeon satisfaction score

  30 minutes after the end of the surgery

• VAS score for pain

  at skin closure and at 1hr, 2 hrs. 3hrs and 6 hrs. after PACU admission.

Study Arms (2)

Magnesium (M) group

EXPERIMENTAL

Magnesium (M) group (n=17) , in which magnesium sulphate is given as adjuvant to propofol for sedation

Drug: Magnesium sulphate; Drug: Propofol

Fentanyl (F) group

ACTIVE COMPARATOR

Fentanyl (F) group (n=17), in which fentanyl is given as adjuvant to propofol for sedation

Drug: Fentanyl; Drug: Propofol

Interventions

Magnesium sulphate DRUG

Magnesium sulphate will be given to the experimental group in a dose of 50mg/kg IV over 15 minutes followed by continuous infusion at 15 mg/kg/h

Magnesium (M) group

Fentanyl DRUG

Fentanyl will be given to the active comparator group in a dose of 1 μg /kg IV bolus over 15 minutes followed by continuous infusion starting at 0.5 μg /kg/h

Fentanyl (F) group

Propofol DRUG

In both groups Fentanyl and magnesium sulphate will be accompanied by IV propofol at a dose of 50- 150 μg /kg) bolus over 15 minutes to achieve target sedation level, that is Ramsay sedation scale (RSS) 3,if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80%

Fentanyl (F) group; Magnesium (M) group

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 50 years
• ASA (American Society of Anesthesiologists physical status) grade I to II
• Glasgow coma scale 14-15
• Unilateral chronic subdural hematoma

You may not qualify if:

• Hypertension (diastolic blood pressure \> 160 mmHg)
• Bradycardia (\<50 bpm)
• Ischemic heart disease (\<6 months)
• Second- or third-degree heart block
• Long-term abuse of or addiction to alcohol, tobacco, opioids, and sedative-hypnotic drugs (\>6 months)
• Allergy to study drugs
• Neuropsychiatric diseases
• Predicted difficult airway according to Ganzouri score \>4.
• Patients with deviation in the surgical technique or with inadequacy of local anesthesia were excluded from the study.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Aini Hospital

Cairo, 11562, Egypt

Location

Related Publications (9)

• Guzel A, Kaya S, Ozkan U, Ufuk Aluclu M, Ceviz A, Belen D. Surgical treatment of chronic subdural haematoma under monitored anaesthesia care. Swiss Med Wkly. 2008 Jul 12;138(27-28):398-403. doi: 10.4414/smw.2008.12121.

  PMID: 18642135 BACKGROUND

• Bishnoi V, Kumar B, Bhagat H, Salunke P, Bishnoi S. Comparison of Dexmedetomidine Versus Midazolam-Fentanyl Combination for Monitored Anesthesia Care During Burr-Hole Surgery for Chronic Subdural Hematoma. J Neurosurg Anesthesiol. 2016 Apr;28(2):141-6. doi: 10.1097/ANA.0000000000000194.

  PMID: 26018670 BACKGROUND

• Sato M, Shirakami G, Fukuda K. Comparison of general anesthesia and monitored anesthesia care in patients undergoing breast cancer surgery using a combination of ultrasound-guided thoracic paravertebral block and local infiltration anesthesia: a retrospective study. J Anesth. 2016 Apr;30(2):244-51. doi: 10.1007/s00540-015-2111-z. Epub 2015 Dec 10.

  PMID: 26661141 BACKGROUND

• Drown MB. Integrative review utilizing dexmedetomidine as an anesthetic for monitored anesthesia care and regional anesthesia. Nurs Forum. 2011 Jul-Sep;46(3):186-94. doi: 10.1111/j.1744-6198.2011.00229.x.

  PMID: 21806629 BACKGROUND

• David H, Shipp J. A randomized controlled trial of ketamine/propofol versus propofol alone for emergency department procedural sedation. Ann Emerg Med. 2011 May;57(5):435-41. doi: 10.1016/j.annemergmed.2010.11.025. Epub 2011 Jan 21.

  PMID: 21256626 BACKGROUND

• Wang W, Feng L, Bai F, Zhang Z, Zhao Y, Ren C. The Safety and Efficacy of Dexmedetomidine vs. Sufentanil in Monitored Anesthesia Care during Burr-Hole Surgery for Chronic Subdural Hematoma: A Retrospective Clinical Trial. Front Pharmacol. 2016 Nov 3;7:410. doi: 10.3389/fphar.2016.00410. eCollection 2016.

  PMID: 27857689 BACKGROUND

• Lauretti GR. Mechanisms of analgesia of intravenous lidocaine. Rev Bras Anestesiol. 2008 May-Jun;58(3):280-6. doi: 10.1590/s0034-70942008000300011. English, Portuguese.

  PMID: 19378524 BACKGROUND

• Cizmeci P, Ozkose Z. Magnesium sulphate as an adjuvant to total intravenous anesthesia in septorhinoplasty: a randomized controlled study. Aesthetic Plast Surg. 2007 Mar-Apr;31(2):167-73. doi: 10.1007/s00266-006-0194-5.

  PMID: 17437152 BACKGROUND

• Prontera A, Baroni S, Marudi A, Valzania F, Feletti A, Benuzzi F, Bertellini E, Pavesi G. Awake craniotomy anesthetic management using dexmedetomidine, propofol, and remifentanil. Drug Des Devel Ther. 2017 Mar 3;11:593-598. doi: 10.2147/DDDT.S124736. eCollection 2017.

  PMID: 28424537 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 Design

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

Model Details: 34 patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: 1. Group A (n=17) will receive magnesium sulphate adjuvant to propofol for sedation. 2. Group B (n=17) will receive fentanyl adjuvant to propofol for sedation

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: June 7, 2018
• Study Start: April 10, 2018
• Primary Completion: August 8, 2018
• Study Completion: August 9, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)