Postoperative PainPhase 3NCT03640390
Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia
A Phase 3 study testing Dexmedetomidine, Magnesium Sulphate and Normal saline in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this work is to compare the hemodynamic and analgesic properties of Dexmedetomidine and Magnesium sulphate infusion in lower abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexmedetomidine, Magnesium Sulphate and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2018to 10 Sep 2019
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged between 18 and 65 years.
- Scheduled for lower abdominal surgery.
Who cannot join
- Systolic blood pressure less than 100 mmHg
- Coagulation disorders
- History of heart failure
- Mitral or Aortic stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia for Lower Abdominal Surgery
The aim of this work is to compare the hemodynamic and analgesic properties of Dexmedetomidine and Magnesium sulphate infusion in lower abdominal surgery.
Read the detailed description
Dexmedetomidine is a relatively new alpha 2 adrenergic receptor agonist with a higher α2/α1 selectivity ratio of 1620:1 that provides analgesic and anesthetic effects . Dexmedetomidine has various clinical uses in anesthesia such as sedation, and prolongation of the duration of postoperative analgesia when used as an adjuvant through intrathecal, epidural, or intravenous routes.
Magnesium sulphate is another commonly used drug in anesthesia. Magnesium sulphate suppresses nociceptive impulses through inhibition of voltage-gated calcium channels and through antagonism of the N-methyl D-aspartate (NMDA) receptors.
Although both drugs were reported to prolong the duration of spinal anesthesia, no studies to the best of our knowledge had compared the analgesic and hemodynamic profile of both drugs when used as intravenously during spinal anesthesia.
- Conditions
- Postoperative Pain
- Being tested
- Dexmedetomidine, Magnesium Sulphate, Normal saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
This group will receive Dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour.
Magnesium SulphateDrug
This group will receive Magnesium sulphate infusion at a rate of 15 mg/Kg/hour
Normal salineDrug
This group will receive normal saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | This group will receive dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour Receives: Drug: Dexmedetomidine |
| Magnesium Sulphate group | Active comparator | This group will receive Magnesium Sulphate infusion at a rate of 15 mg/Kg/hour Receives: Drug: Magnesium Sulphate |
| Saline group | Placebo comparator | This group will receive normal saline infusion Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Duration of analgesia after the operation defined as the time till the first analgesic request by the patient
Measured: 24 hours
Secondary outcomes (7)
Systolic blood pressure
Systolic blood pressure measured in mmHg
Measured: 6 hours
Diastolic blood pressure
Diastolic blood pressure measured in mmHg
Measured: 6 hours
Heart rate
The number of heart beats per minute
Measured: 6 hours
Onset of sensory block
The time needed to have complete sensory block after spinal anesthesia measured in minutes
Measured: 30 minutes after spinal anesthesia
Onset of motor block
The time needed to have complete motor block after spinal anesthesia measured in minutes
Measured: 30 minutes after spinal anesthesia
Duration of motor block
The time needed for recovery of motor motor after spinal anesthesia measured in hours
Measured: 12 hours
Ramsay Sedation Scale
A scale used for assessment of sedation level ranges from 1 (combative) to 6 (unarousable)
Measured: 12 hours 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 posted21 Aug 2018
- Study start30 Aug 2018
- Primary completion30 Aug 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Inas Farouk, Lecturer, Study director, Lecturer of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640390
- Sponsor's protocol ID
- N-112-2017
- Status last verified
- Nov 2019
- First submitted
- 18 Aug 2018
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia for Lower Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03640390
- Acronym / sponsor ID
- N-112-2017
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 21 Aug 2018 (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.
The aim of this work is to compare the hemodynamic and analgesic properties of Dexmedetomidine and Magnesium sulphate infusion in lower abdominal surgery.
Detailed description
Dexmedetomidine is a relatively new alpha 2 adrenergic receptor agonist with a higher α2/α1 selectivity ratio of 1620:1 that provides analgesic and anesthetic effects . Dexmedetomidine has various clinical uses in anesthesia such as sedation, and prolongation of the duration of postoperative analgesia when used as an adjuvant through intrathecal, epidural, or intravenous routes.
Magnesium sulphate is another commonly used drug in anesthesia. Magnesium sulphate suppresses nociceptive impulses through inhibition of voltage-gated calcium channels and through antagonism of the N-methyl D-aspartate (NMDA) receptors.
Although both drugs were reported to prolong the duration of spinal anesthesia, no studies to the best of our knowledge had compared the analgesic and hemodynamic profile of both drugs when used as intravenously during spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineThis group will receive dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour |
| Magnesium Sulphate group | Active comparator | Drug: Magnesium SulphateThis group will receive Magnesium Sulphate infusion at a rate of 15 mg/Kg/hour |
| Saline group | Placebo comparator | Drug: Normal salineThis group will receive normal saline infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients aged between 18 and 65 years.
- Scheduled for lower abdominal surgery.
Key exclusion criteria (4 listed)
- Systolic blood pressure less than 100 mmHg
- Coagulation disorders
- History of heart failure
- Mitral or Aortic stenosis
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexThis group will receive Dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour. | Drug | Dexmedetomidine group |
| Magnesium SulphateThis group will receive Magnesium sulphate infusion at a rate of 15 mg/Kg/hour | Drug | Magnesium Sulphate group |
| Normal salineThis group will receive normal saline infusion | Drug | Saline group |
Primary outcome
Duration of analgesia
Time frame: 24 hours
Duration of analgesia after the operation defined as the time till the first analgesic request by the patient
7 secondary outcomes
Systolic blood pressure
Time frame: 6 hours
Diastolic blood pressure
Time frame: 6 hours
Heart rate
Time frame: 6 hours
Onset of sensory block
Time frame: 30 minutes after spinal anesthesia
Onset of motor block
Time frame: 30 minutes after spinal anesthesia
Duration of motor block
Time frame: 12 hours
Ramsay Sedation Scale
Time frame: 12 hours after spinal anesthesia
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 14 Nov 2019.
- 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.
Inas Farouk, Lecturer study director
Lecturer of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine, Magnesium Sulphate and Normal saline in people with Postoperative Pain, run by Cairo 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 2 inclusion and 4 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 14 Nov 2019. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Duration of analgesia (time frame: 24 hours). 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 14 Nov 2019.