AnesthesiaNCT04232150
Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?
A study testing single-dose midazolam for sedation under spinal anesthesia., Double-dose midazolam for sedation under spinal anesthesia. and spinal anesthesia with no sedation. in people with Anesthesia and Orthopedic Surgery, run by University of Jordan at 1 site in Jordan.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Orthopedic Surgery
- What is being tested?
- single-dose midazolam for sedation under spinal anesthesia., Double-dose midazolam for sedation under spinal anesthesia. and spinal anesthesia with no sedation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jun 2019to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing total knee or total hip replacement.
- ASA I, II, or III.
- patients undergoing spinal anesthesia.
Who cannot join
- patient refusal.
- <24 hours sedative administration.
- patient with hearing impairment.
- neurological or memory disorder.
- abnormal kidney function tests.
- any contraindication for spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Orthopedic Surgery
- Being tested
- single-dose midazolam for sedation under spinal anesthesia., Double-dose midazolam for sedation under spinal anesthesia., spinal anesthesia with no sedation.
- Keywords
- Midazolam, Orthopedic surgery, total knee replacement, total hip replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
spinal anesthesia with no sedation.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group C (control group) | Experimental | control group will receive no sedation under spinal anesthesia. Receives: Procedure: spinal anesthesia with no sedation. |
| Group O (single dose group) | Experimental | patients will receive 0.025mg/kg midazolam sedation under spinal anesthesia. Receives: 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. Receives: Drug: Double-dose midazolam for sedation under spinal anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jun 2019
- Primary completion31 Oct 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Collaborators
- Abdelkarim S. Aloweidi
- Responsible party
- Principal investigator, Mahmoud M. Almustafa, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232150
- Sponsor's protocol ID
- 67/2019/865
- Status last verified
- May 2021
- First submitted
- 6 Jan 2020
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midazolam's Anterograde Amnesia Efficacy in Noisy Orthopedic Surgery: Does Midazolam Cause Effective Anterograde Amnesia in Noisy Orthopedic Surgeries?
- ClinicalTrials.gov ID
- NCT04232150
- Acronym / sponsor ID
- 67/2019/865
- Conditions
- Anesthesia, Orthopedic Surgery
- Keywords
- Midazolam, Orthopedic surgery, total knee replacement, total hip replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Collaborators
- Abdelkarim S. Aloweidi
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group C (control group) | Experimental | Procedure: spinal anesthesia with no sedation.control group will receive no sedation under spinal anesthesia. |
| Group O (single dose group) | Experimental | Drug: single-dose midazolam for sedation under spinal anesthesia.patients will receive 0.025mg/kg midazolam sedation under spinal anesthesia. |
| Group M (double dose group) | Experimental | Drug: Double-dose midazolam for sedation under spinal anesthesia.patients will receive 0.025mg/kg midazolam sedation twice under spinal anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing total knee or total hip replacement.
- ASA I, II, or III.
- patients undergoing spinal anesthesia.
Key exclusion criteria (6 listed)
- patient refusal.
- <24 hours sedative administration.
- patient with hearing impairment.
- neurological or memory disorder.
- abnormal kidney function tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Group O (single dose group) |
| 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. | Drug | Group M (double dose group) |
| 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. | Procedure or surgery | Group C (control group) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single-dose midazolam for sedation under spinal anesthesia., Double-dose midazolam for sedation under spinal anesthesia. and spinal anesthesia with no sedation. in people with Anesthesia and Orthopedic Surgery, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative recall of auditory stimuli and intraoperative noise (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.