Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?

May 28, 2021 updated by: Mahmoud M. Almustafa, University of Jordan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11942
        • Jordan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group C (control group)
control group will receive no sedation under spinal anesthesia.
Procedure: 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.
Experimental: Group O (single dose group)
patients will receive 0.025mg/kg midazolam sedation under spinal anesthesia.
Drug: 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.
Experimental: Group M (double dose group)
patients will receive 0.025mg/kg midazolam sedation twice under spinal anesthesia.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative recall of auditory stimuli and intraoperative noise
Time Frame: 4 months
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
Time Frame: 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Collaborators

Abdelkarim S. Aloweidi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67/2019/865

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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