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Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH (CSDH)

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ClinicalTrials.gov Identifier: NCT03548493
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Rania Samir Fahmy, Kasr El Aini Hospital

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.

Condition or disease Intervention/treatment Phase
Conscious Sedation Drug: Magnesium sulphate Drug: Fentanyl Drug: Propofol Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnesium Sulphate Versus Fentanyl as Adjuvants to Propofol Xylocaine Combination for Conscious Sedation During Chronic Subdural Haematoma Surgery. Comparative Study
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : August 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Magnesium (M) group
Magnesium (M) group (n=17) , in which magnesium sulphate is given as adjuvant to propofol for sedation
Drug: Magnesium sulphate
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

Drug: Propofol
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%

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

Drug: Propofol
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%




Primary Outcome Measures :
  1. Total amount of Propofol consumption in each group [ Time Frame: From the start of propofol infusion after arrival to the operating room and throughout the duration of the surgery ]
    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


Secondary Outcome Measures :
  1. To measure the total number of intraoperative patient's movements [ Time Frame: From the start of the surgery and throughout the duration of the surgery ]
    Intraoperative patient's movement is defined as those likely to interfere with surgical procedure such as bending of hand and/or leg and movement of head

  2. Heart rate [ Time Frame: 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 ]
    Heart rate in beats/min

  3. Non invasive blood pressure [ Time Frame: 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 ]
    Systolic and diastolic blood pressure in mmhg

  4. To assess surgeon satisfaction score [ Time Frame: 30 minutes after the end of the surgery ]
    Surgeon satisfaction was assessed as follows: 1, extremely dissatisfied; 2, not satisfied but able to manage; 3, satisfied; 4, extremely satisfied.

  5. VAS score for pain [ Time Frame: at skin closure and at 1hr, 2 hrs. 3hrs and 6 hrs. after PACU admission. ]
    The pain VAS is a unidimensional measure of pain intensity, the score is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100‐mm scale])

  6. Time to first rescue analgesic [ Time Frame: During the first 24 hours in the postoperative period ]
    The time when the patient first requires analgesia.



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Ages Eligible for Study:   51 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548493


Locations
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Egypt
Kasr El Aini Hospital
Cairo, Egypt, 11562
Sponsors and Collaborators
Kasr El Aini Hospital

Publications:

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Responsible Party: Rania Samir Fahmy, Lecturer of Anesthesia, surgical intensive care and pain mangement, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03548493     History of Changes
Other Study ID Numbers: N-28-2018
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Rania Samir Fahmy, Kasr El Aini Hospital:
Magnesium sulphate
Fentanyl
Conscious sedation
chronic subdural haematoma
Propofol
Burr hole

Additional relevant MeSH terms:
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Hematoma, Subdural, Chronic
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
Hematoma
Hemorrhage
Pathologic Processes
Wounds and Injuries
Magnesium Sulfate
Fentanyl
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents