Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?

NCT04232150 | Completed

• 1 other identifier: 67/2019/865
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Orthopedic Surgery

Keywords

Midazolam; Orthopedic surgery; total knee replacement; total hip replacement

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Group C (control group)

EXPERIMENTAL

control group will receive no sedation under spinal anesthesia.

Procedure: spinal anesthesia with no sedation.

Group O (single dose group)

EXPERIMENTAL

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

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

Group M (double dose group)

EXPERIMENTAL

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

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

Interventions

single-dose midazolam for sedation under spinal anesthesia. 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 O (single dose group)

Double-dose midazolam for sedation under spinal anesthesia. 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.

Group M (double dose group)

spinal anesthesia with no sedation. 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 C (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Jordan: lead
• Abdelkarim S. Aloweidi: collaborator

Study Sites (1)

Jordan University Hospital

Amman, 11942, Jordan

Location

MeSH Terms

Interventions

Midazolam; Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 18, 2020
• Study Start: June 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: November 1, 2019
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)