Sedation During Spinal AnesthesiaPhase 2NCT03133780
Sedation During Spinal Anesthesia
A Phase 2 study testing Ketamine and Midazolam in people with Sedation During Spinal Anesthesia, run by Assiut University at 1 site in Egypt.
Trial summary
Patients during spinal anesthesia should be sedated. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Sedation During Spinal Anesthesia
- What is being tested?
- Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jul 2018to 7 Mar 2020
- Phase
- Phase 2
- 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 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients aged from 18 to 50 years old undergoing elective unilateral inguinal hernia repair with no neurological, cardiovascular and hepato-renal abnormalities.
Who cannot join
- Age: younger than 18 or older than 50.
- Psychatric or neurological disorders.
- Cardiovascular disorders.
- Coagulation disorders.
- Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Assuit University
Asyut, Asyut Governorate, 71516
About this study
Official title: A Comparison of the Sedative Effect of Ketamine and Midazolam During Spinal Anaesthesia for Elective Unilateral Inguinal Hernia Repair: A Randomized Comparative Trial
Patients during spinal anesthesia should be sedated.
Read the detailed description
Spinal anesthesia offers a number of advantages to both the patient and the physician. However, patients are often reluctant to remain awake during a procedure. Sedation has been shown to increase patient satisfaction during regional anesthesia and may be considered as a means to increase the patient's acceptance.Therefore, provision of adequate sedation is important if the advantages of spinal anesthesia are to be fully appreciated.
- Conditions
- Sedation During Spinal Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Patient will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
MidazolamDrug
Also called dormicum
Patient will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | Patients will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min Receives: Drug: Ketamine |
| Midazolam | Active comparator | Patients will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score
assessed by modified observer's assessment of alertness/sedation score
Measured: 90 minutes after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start14 Jul 2018
- Primary completion7 Mar 2020
- Study completion7 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation During Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
- Investigators
- Seham M Moeen, MD, Principal investigator, Assiut Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133780
- Sponsor's protocol ID
- 42017
- Status last verified
- Feb 2024
- First submitted
- 26 Apr 2017
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Sedative Effect of Ketamine and Midazolam During Spinal Anaesthesia for Elective Unilateral Inguinal Hernia Repair: A Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT03133780
- Acronym / sponsor ID
- 42017
- Conditions
- Sedation During Spinal Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Jul 2018 (actual)
- Primary completion
- 7 Mar 2020 (actual)
- Study completion
- 7 Mar 2020 (actual)
- First posted
- 28 Apr 2017 (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.
Patients during spinal anesthesia should be sedated.
Detailed description
Spinal anesthesia offers a number of advantages to both the patient and the physician. However, patients are often reluctant to remain awake during a procedure. Sedation has been shown to increase patient satisfaction during regional anesthesia and may be considered as a means to increase the patient's acceptance.Therefore, provision of adequate sedation is important if the advantages of spinal anesthesia are to be fully appreciated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: KetaminePatients will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min |
| Midazolam | Active comparator | Drug: MidazolamPatients will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male patients aged from 18 to 50 years old undergoing elective unilateral inguinal hernia repair with no neurological, cardiovascular and hepato-renal abnormalities.
Key exclusion criteria (5 listed)
- Age: younger than 18 or older than 50.
- Psychatric or neurological disorders.
- Cardiovascular disorders.
- Coagulation disorders.
- Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).
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 |
|---|---|---|
| KetamineAlso: KetalarPatient will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min | Drug | Ketamine |
| MidazolamAlso: dormicumPatient will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min | Drug | Midazolam |
Primary outcome
Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score
Time frame: 90 minutes after spinal anesthesia
assessed by modified observer's assessment of alertness/sedation score
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 21 Feb 2024.
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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.
Seham M Moeen, MD principal investigator
Assiut Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and Midazolam in people with Sedation During Spinal Anesthesia, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 5 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 21 Feb 2024. 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score (time frame: 90 minutes after spinal anesthesia). 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 21 Feb 2024.