Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?

Sponsor

University of Jordan (Other)

Overall Status

Completed

CT.gov ID

NCT04232150

Collaborator

Abdelkarim S. Aloweidi (Other)

116

Enrollment

Location

Arms

Actual Duration (Months)

23.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Orthopedic Surgery	Drug: single-dose midazolam for sedation under spinal anesthesia. Drug: Double-dose midazolam for sedation under spinal anesthesia. Procedure: spinal anesthesia with no sedation.	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Nov 1, 2019

Arms and Interventions

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.

Arm

Intervention/Treatment

Experimental: Group C (control group)

control group will receive no sedation under spinal anesthesia.

Procedure: spinal anesthesia with no sedation.

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.

Outcome Measures

Primary Outcome Measures

Postoperative recall of auditory stimuli and intraoperative noise [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.
Postoperative recall of visual stimuli [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jordan University Hospital	Amman		Jordan	11942

Sponsors and Collaborators

University of Jordan
Abdelkarim S. Aloweidi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahmoud M. Almustafa, Principal Investigator, University of Jordan

ClinicalTrials.gov Identifier:

NCT04232150

Other Study ID Numbers:

67/2019/865

First Posted:

Jan 18, 2020

Last Update Posted:

Jun 3, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mahmoud M. Almustafa, Principal Investigator, University of Jordan

Midazolam

Orthopedic surgery

total knee replacement

total hip replacement

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2021