Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Midazolam's Anterograde Amnesia Efficacy in Noisy Orthopedic Surgery: Does Midazolam Cause Effective Anterograde Amnesia in Noisy Orthopedic Surgeries?

Conditions
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Anesthesia, Orthopedic Surgery

Intervention / Treatment
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* Drug: single-dose midazolam for sedation under spinal anesthesia.
* Drug: Double-dose midazolam for sedation under spinal anesthesia.
* Procedure: spinal anesthesia with no sedation.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Overall, 116 patients were enrolled, out of which 20 were excluded before start of study for the following reasons: contraindication for spinal anesthesia (n=10), preoperative administration of sedative agent (n=3), refusal to be enrolled in study (n=4), a patient with neurological disorder (Schizophrenia), a blind patient, and a deaf patient. Of the 96 patients included, 33 were enrolled in group C, 32 in group S; however, 2 patients requested a deeper level of sedation so an added dose of midazolam and fentanyl were given thus excluding them from study, and 31 patients in group R.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group C (control group)<br>control group will receive no sedation under spinal anesthesia. | Procedure: spinal anesthesia with no sedation.<br>* Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring.<br>|
| Experimental: Group O (single dose group)<br>patients will receive 0.025mg/kg midazolam sedation under spinal anesthesia. | Drug: single-dose midazolam for sedation under spinal anesthesia.<br>* Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring. Group O received 0.025mg/kg midazolam at skin incision.<br>|
| Experimental: Group M (double dose group)<br>patients will receive 0.025mg/kg midazolam sedation twice under spinal anesthesia. | Drug: Double-dose midazolam for sedation under spinal anesthesia.<br>* Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring. Group M received 0.025mg/kg midazolam at skin incision and repeated 5 minutes before maximum stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative recall of auditory stimuli and intraoperative noise | For auditory recall, a question was asked by the surgeon to the patient at maximum stimulation. Patients were examined for auditory recall by following-up the patients postoperatively in the inpatient department. | 4 months | 
| Postoperative recall of visual stimuli | For visual recall, a picture of a horse assigned at maximum stimulation, a cat at recovery room, and a bird after discharge to the inpatient department. Patients were examined for visual recall by following-up the patients postoperatively in the inpatient department. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midazolam, Orthopedic surgery, total knee replacement, total hip replacement