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Magnesium Sulphate Versus Fentanyl Sedation During Burr-hole Surgery

NCT03854812 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-04-13

No results posted yet for this study

Summary

MgSO4 was found to reduce the perioperative anesthetic and analgesic requirements when used as an adjuvant to general anesthesia. Fentanyl is a potent opioid and used as adjuvant to other sedatives in awake craniotomy procedure. No study, to the best of our knowledge had evaluated fentanyl continuous infusion, nor MgSo4 infusion as adjuvant sedative agents to propofol during Burr-hole surgery. The aim of this study is to evaluate and compare MgSO4 versus fentanyl continuous infusions for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural hematoma with local infiltration.

Conditions

  • Monitored Anesthesia Care

Interventions

DRUG

Magnesium Sulphate

a loading of 50 mg/kg in 15 minutes of Magnesium sulphate, and will be followed by continuous infusion at 1 ml/kg/h of 15 mg/ml solution

DRUG

Fentanyl

loading of 1 mcg/kg in over 15 minutes of fentanyl then will receive continuous infusion starting at 1 ml /kg/h. of 0.5 mcg/ml solution

DRUG

Propofol

0.5-1.5 mg/kg bolus of propofol over 10 minutes to achieve target Ramsay sedation scale (RSS) of 3 (respond to command), if RSS afterwards does not reach 3 a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, and will be followed by 1-2.5 mg/kg/hr infusion to maintain Intraoperative BIS readings between 60 - 80

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Principal Investigators

  • Maha mostafa, MD · kasr el aini

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-10-12
Completion
2019-10-12

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 NCT03854812 on ClinicalTrials.gov