Spinal Anesthesia Suitability for AbdominoplastyNCT03810547
Abdominoplasty Under Spinal Anesthesia
A study testing Propofol 10 Mg/mL Intravenous Emulsion in people with Spinal Anesthesia Suitability for Abdominoplasty, run by Ain Shams University at 1 site in Egypt.
Trial summary
100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing abdominoplasty under general anesthesia Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia Suitability for Abdominoplasty
- What is being tested?
- Propofol 10 Mg/mL Intravenous Emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2017to 31 Dec 2018
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients between 18-55 years
- ASA I and II
Who cannot join
- BMI more than 35 years
- Contraindications for regional anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Spinal and General Anesthesia for Abdominoplasty.
100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing abdominoplasty under general anesthesia
Read the detailed description
200 patients, American Society of Anesthesiologists (ASA) physical status classes I and II, were enrolled in this feasible study. All patients were subjected to abdominoplasty operation under spinal anesthesia or general anesthesia. Any intraoperative complications like hypotension, bradycardia, pain, nausea and vomiting related to spinal anesthesia were managed and recorded. Postoperative visual analogue scale (VAS) was used to assess pain severity and the need for analgesia to be administered.
- Being tested
- Propofol 10 Mg/mL Intravenous Emulsion
- Keywords
- Abdominoplasty, spinal anesthesia, general anesthesia, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol 10 Mg/mL Intravenous EmulsionDrug
Also called ketamine
when spinal anesthesia is not satisfactory intervention drugs are used
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia | Active comparator | Patients undergoing abdominoplasty under spinal anesthesia may need to drug administration like propofol or ketamine or change anesthesia to general anesthesia. Receives: Drug: Propofol 10 Mg/mL Intravenous Emulsion |
| General anesthesia | No intervention | General anesthesia for abdominoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain sensation: Visual analogue scale
Visual analogue scale for Pain assessment from 1 with least pain to 10 with maximum pain felt
Measured: pain assessment during the operation and every 4 hours for 12 hours
Patients satisfaction: Satisfaction score changes
Satisfaction score with maximum score is fully satisfied and least is completely disagree
Measured: Intraoperative assessment every 30 minutes till end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start30 Jan 2017
- Primary completion30 Apr 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthesia Suitability for AbdominoplastyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Anis Metry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810547
- Sponsor's protocol ID
- ASUH1011/17
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- 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 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Spinal and General Anesthesia for Abdominoplasty.
- ClinicalTrials.gov ID
- NCT03810547
- Acronym / sponsor ID
- ASUH1011/17
- Keywords
- Abdominoplasty, spinal anesthesia, general anesthesia, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Jan 2019 (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.
100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing abdominoplasty under general anesthesia
Detailed description
200 patients, American Society of Anesthesiologists (ASA) physical status classes I and II, were enrolled in this feasible study. All patients were subjected to abdominoplasty operation under spinal anesthesia or general anesthesia. Any intraoperative complications like hypotension, bradycardia, pain, nausea and vomiting related to spinal anesthesia were managed and recorded. Postoperative visual analogue scale (VAS) was used to assess pain severity and the need for analgesia to be administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | Active comparator | Drug: Propofol 10 Mg/mL Intravenous EmulsionPatients undergoing abdominoplasty under spinal anesthesia may need to drug administration like propofol or ketamine or change anesthesia to general anesthesia. |
| General anesthesia | No intervention | –General anesthesia for abdominoplasty |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All patients between 18-55 years
- ASA I and II
Key exclusion criteria (2 listed)
- BMI more than 35 years
- Contraindications for regional anesthesia
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 |
|---|---|---|
| Propofol 10 Mg/mL Intravenous EmulsionAlso: ketaminewhen spinal anesthesia is not satisfactory intervention drugs are used | Drug | Spinal anesthesia |
Primary outcome
Change in Pain sensation: Visual analogue scale
Time frame: pain assessment during the operation and every 4 hours for 12 hours
Visual analogue scale for Pain assessment from 1 with least pain to 10 with maximum pain felt
Patients satisfaction: Satisfaction score changes
Time frame: Intraoperative assessment every 30 minutes till end of surgery.
Satisfaction score with maximum score is fully satisfied and least is completely disagree
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 22 Jan 2019.
- Individual participant dataSharing planned: No
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 Propofol 10 Mg/mL Intravenous Emulsion in people with Spinal Anesthesia Suitability for Abdominoplasty, run by Ain Shams 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 2 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 22 Jan 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. 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?
Change in Pain sensation: Visual analogue scale (time frame: pain assessment during the operation and every 4 hours for 12 hours). 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 22 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.