Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

April 10, 2018

Primary Completion Date

August 8, 2018

Study Completion Date

August 9, 2018

Conditions
Conscious Sedation
Interventions
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

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%

Trial Locations (1)

11562

Kasr El Aini Hospital, Cairo

All Listed Sponsors
lead

Kasr El Aini Hospital

OTHER

NCT03548493 - Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH | Biotech Hunter | Biotech Hunter