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Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH

NCT03548493 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-12-04

No results posted yet for this study

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

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%

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
51 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2018-08-08
Completion
2018-08-09

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03548493 on ClinicalTrials.gov