Combination of General Anesthesia to Spinal and Epidural TechniquesNCT05301127
Combination of Spinal-Epidural With General Anesthesia in Patients Undergoing Mega-Liposuction Surgery
A study testing spinal-epidural device in people with Combination of General Anesthesia to Spinal and Epidural Techniques, run by Cairo University at 1 site in Egypt.
Trial summary
The combination of general anesthesia to spinal and epidural techniques (CSEGA) proved to have a synergistic effect, thus, the use of sub-anesthetic doses can provide satisfactory anesthetic and analgesic results. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Combination of General Anesthesia to Spinal and Epidural Techniques
- What is being tested?
- spinal-epidural device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jan 2022to 1 Oct 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
- Inclusion criteria:
- Patients aged from 18 to50 years.
- ASA I-II.
- undergoing elective liposuction surgery
- BMI from 25 to 40 kg/m2
- Exclusion criteria:
- Patient refusal
- ASA III-IV.
- Patients aged less than 18 or more than 50.
- Body mass index >40.
- Any contraindications to neuro-axial block such as coagulopathy or spine deformity
- Chronic opioid consumption,
- History of parenteral or oral analgesic intake within the last 48hours.
Trial locations and contacts
1 site in 1 country.
About this study
The combination of general anesthesia to spinal and epidural techniques (CSEGA) proved to have a synergistic effect, thus, the use of sub-anesthetic doses can provide satisfactory anesthetic and analgesic results. CSEGA has several known advantages including appropriate postoperative analgesia, shows some benefit in the intraoperative blood loss control causing a decreased need for blood transfusion, rapid regain of the gastrointestinal actions and decreases the incidence of postoperative respiratory complications. Unfortunately, the drawbacks of using neuro-axial anesthesia in combination to general anesthesia will be not thoroughly introduced in many researches, thus, remain unclear.
- Being tested
- spinal-epidural device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal-epidural deviceDevice
received combined spinal-epidural-general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| CSEGA group | Active comparator | Will be received combined spinal-epidural-general anesthesia. Receives: Device: spinal-epidural device |
| GA group | No intervention | will be received general anesthesia only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
postoperative morphine consumption
Measured: 24 hours
Secondary outcomes (4)
Postoperative patient satisfaction
1 = very unsatisfactory; 2 = unsatisfactory; 3 = indifferent; 4 = satisfactory; and 5 = very satisfactory.
Measured: 24 hours
Intraoperative surgeon satisfaction.
using 1-4 scales (1, bad; 2, moderate; 3, good; 4, excellent;
Measured: 6 hours
Incidence of complications
such as hypotension, bradycardia, nausea and vomiting, postoperative shivering,
Measured: 24 hours
Blood loss
intraoperative Blood loss
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start11 Jan 2022
- Primary completion13 Aug 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combination of General Anesthesia to Spinal and Epidural TechniquesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301127
- Sponsor's protocol ID
- N-54-2021
- Status last verified
- Oct 2024
- First submitted
- 19 Mar 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still working
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Spinal-Epidural With General Anesthesia in Patients Undergoing Mega-Liposuction Surgery
- ClinicalTrials.gov ID
- NCT05301127
- Acronym / sponsor ID
- N-54-2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 29 Mar 2022 (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 combination of general anesthesia to spinal and epidural techniques (CSEGA) proved to have a synergistic effect, thus, the use of sub-anesthetic doses can provide satisfactory anesthetic and analgesic results. CSEGA has several known advantages including appropriate postoperative analgesia, shows some benefit in the intraoperative blood loss control causing a decreased need for blood transfusion, rapid regain of the gastrointestinal actions and decreases the incidence of postoperative respiratory complications. Unfortunately, the drawbacks of using neuro-axial anesthesia in combination to general anesthesia will be not thoroughly introduced in many researches, thus, remain unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSEGA group | Active comparator | Device: spinal-epidural deviceWill be received combined spinal-epidural-general anesthesia. |
| GA group | No intervention | –will be received general anesthesia only. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| spinal-epidural devicereceived combined spinal-epidural-general anesthesia. | Device | CSEGA group |
Primary outcome
morphine consumption
Time frame: 24 hours
postoperative morphine consumption
4 secondary outcomes
Postoperative patient satisfaction
Time frame: 24 hours
Intraoperative surgeon satisfaction.
Time frame: 6 hours
Incidence of complications
Time frame: 24 hours
Blood loss
Time frame: 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 15 Oct 2024.
- Individual participant dataSharing planned: Undecided. still working
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 spinal-epidural device in people with Combination of General Anesthesia to Spinal and Epidural Techniques, 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?
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 15 Oct 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.
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?
morphine consumption (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 15 Oct 2024.