Overview

Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH

Status:
Completed
Trial end date:
2018-08-09
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kasr El Aini Hospital
Treatments:
Fentanyl
Magnesium Sulfate
Propofol
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.