Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04232150
• Other study ID #: 67/2019/865
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: May 2021
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: November 1, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amnesia
• Anesthesia
• Orthopedic Surgery

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman

Sponsors (2)

Lead Sponsor	Collaborator
University of Jordan	Abdelkarim S. Aloweidi

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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