A Comparison of the Sedative Effect of Ketamine and Midazolam During Spinal Anaesthesia for Elective Unilateral Inguinal Hernia Repair: A Randomized Comparative Trial
Overview
- Phase
- Phase 2
- Intervention
- Ketamine
- Conditions
- Sedation During Spinal Anesthesia
- Sponsor
- Assiut University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Seham Mohamed Moeen Ibrahim
Principal Investigator
Assiut University
Eligibility Criteria
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.
Exclusion Criteria
- •Age: younger than 18 or older than
- •Psychatric or neurological disorders.
- •Cardiovascular disorders.
- •Coagulation disorders.
- •Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).
Arms & Interventions
Ketamine
Patients will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
Intervention: Ketamine
Midazolam
Patients will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
Intervention: Midazolam
Outcomes
Primary Outcomes
Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score
Time Frame: 90 minutes after spinal anesthesia
assessed by modified observer's assessment of alertness/sedation score