Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-11-01

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.

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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.

Conditions

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Anesthesia Orthopedic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group C (control group)

control group will receive no sedation under spinal anesthesia.

Group Type EXPERIMENTAL

spinal anesthesia with no sedation.

Intervention Type PROCEDURE

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 (single dose group)

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

Group Type EXPERIMENTAL

single-dose midazolam for sedation under spinal anesthesia.

Intervention Type DRUG

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.

Group M (double dose group)

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

Group Type EXPERIMENTAL

Double-dose midazolam for sedation under spinal anesthesia.

Intervention Type DRUG

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.

Interventions

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single-dose midazolam for sedation under spinal anesthesia.

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.

Intervention Type DRUG

Double-dose midazolam for sedation under spinal anesthesia.

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.

Intervention Type DRUG

spinal anesthesia with no sedation.

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.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes