Sedation During Spinal Anesthesia

Assiut University

Status and phase: Completed; Phase 2

Conditions: Sedation During Spinal Anesthesia

Treatments: Drug: Ketamine; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT03133780

42017

Details and patient eligibility

About

Patients during spinal anesthesia should be sedated.

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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 50.
• Psychatric or neurological disorders.
• Cardiovascular disorders.
• Coagulation disorders.
• Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Ketamine

Active Comparator group

Description:

Patients will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

Treatment:

Drug: Ketamine

Midazolam

Active Comparator group

Description:

Patients will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min

Treatment:

Drug: Midazolam