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Sedation During Spinal Anesthesia

Phase 2
Completed
Conditions
Sedation During Spinal Anesthesia
Interventions
Registration Number
NCT03133780
Lead Sponsor
Assiut University
Brief Summary

Patients during spinal anesthesia should be sedated.

Detailed Description

Spinal anesthesia offers a number of advantages to both the patient and the physician. However, patients are often reluctant to remain awake during a procedure. Sedation has been shown to increase patient satisfaction during regional anesthesia and may be considered as a means to increase the patient's acceptance.Therefore, provision of adequate sedation is important if the advantages of spinal anesthesia are to be fully appreciated.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
80
Inclusion Criteria
  • Male patients aged from 18 to 50 years old undergoing elective unilateral inguinal hernia repair with no neurological, cardiovascular and hepato-renal abnormalities.
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Exclusion Criteria
  • Age: younger than 18 or older than 50.
  • Psychatric or neurological disorders.
  • Cardiovascular disorders.
  • Coagulation disorders.
  • Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
KetamineKetaminePatients will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
MidazolamMidazolamPatients will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
Primary Outcome Measures
NameTimeMethod
Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score90 minutes after spinal anesthesia

assessed by modified observer's assessment of alertness/sedation score

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Faculty of Medicine Assuit University

🇪🇬

Assiut, Asyut, Egypt

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