CompletedPhase 2

Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH

Egypt34 participantsStarted 2018-04-10

Plain-language 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.

Who can participate

Age range

51 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total amount of Propofol consumption in each group

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

Trial details

NCT IDNCT03548493

SponsorKasr El Aini Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-08-08

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