Gynecologic Laparoscopic SurgeryPhase 2NCT02671227
Intrathecal Mg in Gynecologic Laparoscopic Surgeries.
A Phase 2 study testing intrathecal Mg sulfate. and intrathecal bupivacaine 15 mg. in people with Gynecologic Laparoscopic Surgery, run by Assiut University at 1 site in Egypt.
Trial summary
The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative pain in gynecologic laparoscopic surgeries. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Laparoscopic Surgery
- What is being tested?
- intrathecal Mg sulfate. and intrathecal bupivacaine 15 mg.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2016to Jan 2017
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female patient.
- more than 18 years.
- undergoing elective gynecologic laparoscopic surgeries.
Who cannot join
- allergy to local anesthesia.
- contraindication to spinal anesthesia.
- Significant cardiac, liver or renal dysfunction.
- Inability to informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Surgeon Satisfaction and Postoperative Pain in Gynecologic Laparoscopic Surgeries.
The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative pain in gynecologic laparoscopic surgeries.
Read the detailed description
The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction, patient satisfaction and postoperative pain in gynecologic laparoscopic surgeries.
- Conditions
- Gynecologic Laparoscopic Surgery
- Being tested
- intrathecal Mg sulfate., intrathecal bupivacaine 15 mg.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal Mg sulfate.Drug
intrathecal Mg sulfate 50 mg.
intrathecal bupivacaine 15 mg.Drug
intrathecal bupivacaine 15 mg.
| Study group | Role | What they receive |
|---|---|---|
| intrathecal bupivacaine + Mg sulfate | Active comparator | intrathecal bupivacaine 15 mg + intrathecal Mg sulfate 50 mg. in gynecologic laparoscopic surgeries. Receives: Drug: intrathecal Mg sulfate.; Drug: intrathecal bupivacaine 15 mg. |
| intrathecal bupivacaine | Active comparator | intrathecal bupivacaine 15 mg in gynecologic laparoscopic surgeries. Receives: Drug: intrathecal bupivacaine 15 mg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgeon satisfaction (scale from 1 to 10) .
surgeon satisfaction (scale from 1 to 10) as 1 is worst and 10 is best.
Measured: intraoperative (from beginning of the gynecologic laparoscopic procedure till the end of the procedure).
Secondary outcomes (1)
postoperative pain management (VAS score).
Visual Analog Scale (VAS score).
Measured: postoperative for 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Laparoscopic SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled salah mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671227
- Sponsor's protocol ID
- intrathecal Mg in gyne. lap.
- Status last verified
- Aug 2016
- First submitted
- 24 Jan 2016
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Surgeon Satisfaction and Postoperative Pain in Gynecologic Laparoscopic Surgeries.
- ClinicalTrials.gov ID
- NCT02671227
- Acronym / sponsor ID
- intrathecal Mg in gyne. lap.
- Conditions
- Gynecologic Laparoscopic Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Feb 2016 (estimated)
- 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 investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative pain in gynecologic laparoscopic surgeries.
Detailed description
The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction, patient satisfaction and postoperative pain in gynecologic laparoscopic surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrathecal bupivacaine + Mg sulfate | Active comparator | Drug: intrathecal Mg sulfate., Drug: intrathecal bupivacaine 15 mg.intrathecal bupivacaine 15 mg + intrathecal Mg sulfate 50 mg. in gynecologic laparoscopic surgeries. |
| intrathecal bupivacaine | Active comparator | Drug: intrathecal bupivacaine 15 mg.intrathecal bupivacaine 15 mg in gynecologic laparoscopic surgeries. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female patient.
- more than 18 years.
- undergoing elective gynecologic laparoscopic surgeries.
Key exclusion criteria (4 listed)
- allergy to local anesthesia.
- contraindication to spinal anesthesia.
- Significant cardiac, liver or renal dysfunction.
- Inability to informed consent
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 |
|---|---|---|
| intrathecal Mg sulfate.intrathecal Mg sulfate 50 mg. | Drug | intrathecal bupivacaine + Mg sulfate |
| intrathecal bupivacaine 15 mg.intrathecal bupivacaine 15 mg. | Drug | intrathecal bupivacaine, intrathecal bupivacaine + Mg sulfate |
Primary outcome
surgeon satisfaction (scale from 1 to 10) .
Time frame: intraoperative (from beginning of the gynecologic laparoscopic procedure till the end of the procedure).
surgeon satisfaction (scale from 1 to 10) as 1 is worst and 10 is best.
1 secondary outcome
postoperative pain management (VAS score).
Time frame: postoperative for 6 hours.
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 27 Jan 2017.
- Individual participant dataSharing planned: Yes
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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 Phase 2 study testing intrathecal Mg sulfate. and intrathecal bupivacaine 15 mg. in people with Gynecologic Laparoscopic Surgery, 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 3 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 27 Jan 2017. 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?
surgeon satisfaction (scale from 1 to 10) . (time frame: intraoperative (from beginning of the gynecologic laparoscopic procedure till the end of the procedure).). 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 27 Jan 2017.