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Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?

Primary Purpose

Anesthesia, Orthopedic Surgery

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
single-dose midazolam for sedation under spinal anesthesia.
Double-dose midazolam for sedation under spinal anesthesia.
spinal anesthesia with no sedation.
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia focused on measuring Midazolam, Orthopedic surgery, total knee replacement, total hip replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Jordan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group C (control group)

Group O (single dose group)

Group M (double dose group)

Arm Description

control group will receive no sedation under spinal anesthesia.

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2020
Last Updated
May 28, 2021
Sponsor
University of Jordan
Collaborators
Abdelkarim S. Aloweidi
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1. Study Identification

Unique Protocol Identification Number
NCT04232150
Brief Title
Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?
Official Title
Midazolam's Anterograde Amnesia Efficacy in Noisy Orthopedic Surgery: Does Midazolam Cause Effective Anterograde Amnesia in Noisy Orthopedic Surgeries?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan
Collaborators
Abdelkarim S. Aloweidi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Orthopedic Surgery
Keywords
Midazolam, Orthopedic surgery, total knee replacement, total hip replacement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C (control group)
Arm Type
Experimental
Arm Description
control group will receive no sedation under spinal anesthesia.
Arm Title
Group O (single dose group)
Arm Type
Experimental
Arm Description
patients will receive 0.025mg/kg midazolam sedation under spinal anesthesia.
Arm Title
Group M (double dose group)
Arm Type
Experimental
Arm Description
patients will receive 0.025mg/kg midazolam sedation twice under spinal anesthesia.
Intervention Type
Drug
Intervention Name(s)
single-dose midazolam for sedation under spinal anesthesia.
Intervention Description
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
Intervention Name(s)
Double-dose midazolam for sedation under spinal anesthesia.
Intervention Description
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
Procedure
Intervention Name(s)
spinal anesthesia with no sedation.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative recall of auditory stimuli and intraoperative noise
Description
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.
Time Frame
4 months
Title
Postoperative recall of visual stimuli
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Jordan University Hospital
City
Amman
ZIP/Postal Code
11942
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No

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Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?

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