Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?

University of Jordan

Status: Completed

Conditions: Orthopedic Surgery; Anesthesia

Treatments: Drug: single-dose midazolam for sedation under spinal anesthesia.; Procedure: spinal anesthesia with no sedation.; Drug: Double-dose midazolam for sedation under spinal anesthesia.

Study type: Interventional

Funder types: Other

Identifiers

NCT04232150

67/2019/865

Details and patient eligibility

About

Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.

Full description

Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The main goals of sedation for surgeries under spinal anesthesia are patient comfort, preservation of protective airway reflexes, and the help in the maintenance of hemodynamic stability during the surgical procedure. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients undergoing total knee or total hip replacement.
• ASA I, II, or III.
• patients undergoing spinal anesthesia.

Exclusion criteria

• patient refusal.
• <24 hours sedative administration.
• patient with hearing impairment.
• neurological or memory disorder.
• abnormal kidney function tests.
• any contraindication for spinal anesthesia.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 3 patient groups

Group C (control group)

Experimental group

Description:

control group will receive no sedation under spinal anesthesia.

Treatment:

Procedure: spinal anesthesia with no sedation.

Group O (single dose group)

Experimental group

Description:

patients will receive 0.025mg/kg midazolam sedation under spinal anesthesia.

Treatment:

Drug: single-dose midazolam for sedation under spinal anesthesia.

Group M (double dose group)

Experimental group

Description:

patients will receive 0.025mg/kg midazolam sedation twice under spinal anesthesia.

Treatment:

Drug: Double-dose midazolam for sedation under spinal anesthesia.