Patient ComplianceNCT03437980
Propofol Spinal Procedural Sedation for Cesarean Section
A study testing propofol in people with Patient Compliance, run by Mansoura University at 3 sites in Egypt.
Trial summary
Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence, guidelines and quality markers, regional anesthesia is preferred over general anesthesia in obstetric surgery. A high level of anxiety is present in obstetric patients preoperatively. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Patient Compliance
- What is being tested?
- propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Apr 2018to 10 Sep 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for elective cesarean section,
- Age: 18 - 40 years,
- American Society of Anesthesiologists I - III,
- Patients may present any of the following conditions:
- Respiratory diseases as bronchial asthma
- Hepatic compromise,
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- Preeclampsia,
- Anemia with hemoglobin 10 g/dl,
- Previous sections,
- Obese with BMI more than 35%,
- Any criteria of difficult intubation, Compromised fetus as premature delivery, History of complications or non-satisfaction after general anesthesia during previous cesarean section,
Who cannot join
- Patients refusing to participate in the study,
- Known psychiatric disease,
- Addiction medications,
- Communication barrier,
- Absolute or relative contraindication for spinal anesthesia,
- Bad obstetric history, complicated pregnancy, congenital fetal anomaly.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Delta Hospital
Al Mansurah, Dakahlya, 35516
Mansoura University Hospital
Al Mansurah, Dakahlya, 35516
Zagazig University Hospital
Zagazig, Sharkya, 44519
About this study
Official title: Can Propofol Procedural Sedation Implementation Increase the Acceptance of Spinal Anesthesia During Cesarean Section?
Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence, guidelines and quality markers, regional anesthesia is preferred over general anesthesia in obstetric surgery. A high level of anxiety is present in obstetric patients preoperatively. Patients with high anxiety tend to prefer general anesthesia for cesarean section. The anxiety can be reduced variably by non-pharmacologic and pharmacologic methods. The evidence supports the benefits of procedural sedation for distressed, anxious pregnant women.
Read the detailed description
Propofol provides short onset, rapid predictable action, anxiolysis and amnesia and it is more effective than benzodiazepines. Using propofol infusion in low doses during spinal injection in CS did not adversely affect the Apgar scores or the neurological and adaptive fetal outcomes. The general consensus is that procedural sedation is not a routine for spinal interventions, but required for anxious patients. Our hypothesis is that, with the high prevalence of maternal anxiety during cesarean section, ensuring painless comfortable spinal anesthesia may increase the acceptance rate of regional anesthesia during cesarean section.
- Conditions
- Patient Compliance
- Being tested
- propofol
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called propofol procedural sedation
A bolus of 0.7 mg/kg will be given initially, additional incremental doses of 20 mg propofol will be given if the patient complained of pain or moved arms towards the back. Patients will be sitting on the middle of the operating table facing towards the table's foot. The table's foot will be dropped 45 degrees for a comfortable chair position, Monitoring through pulse oximeter (SaO2), non-invasive blood pressure (NIBP) adjusted every 2 minutes automatic measuring and capnography tube in contact with nostrils.
| Study group | Role | What they receive |
|---|---|---|
| propofol spinal acceptance | Experimental | The surgeon and the anesthetist will discuss the exclusion criteria. Then they will discuss the information's about spinal and general anesthesia with the illegible patients, also reply the patient's questions in a preoperative visit. The primary decision for the patient; either spinal or general anesthesia will be recorded.
The patients refusing spinal anesthesia will be discussed again to detect the rate of acceptance of spinal anesthesia if propofol sedation is ensured during the procedure to provide a painless spinal injection. The final decision will be applied; either spinal with procedural sedation, or general anesthesia. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure.
percent
Measured: 30 minutes preoperative.
Secondary outcomes (2)
The rate of initial acceptance of spinal anesthesia without sedation.
percent
Measured: 30 minutes preoperative.
The anxiety score.
by the visual analogue score from 0-10, where 10 is the maximum anxiety level.
Measured: 30 minutes preoperative,10 minutes after spinal injection, and 30 minutes after stay at recovery room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Apr 2018
- Primary completion10 Jul 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mazy Mazy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437980
- Sponsor's protocol ID
- R.18.02.23
- Status last verified
- Sep 2020
- First submitted
- 4 Feb 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Propofol Procedural Sedation Implementation Increase the Acceptance of Spinal Anesthesia During Cesarean Section?
- ClinicalTrials.gov ID
- NCT03437980
- Acronym / sponsor ID
- R.18.02.23
- Conditions
- Patient Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 19 Feb 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.
Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence, guidelines and quality markers, regional anesthesia is preferred over general anesthesia in obstetric surgery. A high level of anxiety is present in obstetric patients preoperatively. Patients with high anxiety tend to prefer general anesthesia for cesarean section. The anxiety can be reduced variably by non-pharmacologic and pharmacologic methods. The evidence supports the benefits of procedural sedation for distressed, anxious pregnant women.
Detailed description
Propofol provides short onset, rapid predictable action, anxiolysis and amnesia and it is more effective than benzodiazepines. Using propofol infusion in low doses during spinal injection in CS did not adversely affect the Apgar scores or the neurological and adaptive fetal outcomes. The general consensus is that procedural sedation is not a routine for spinal interventions, but required for anxious patients. Our hypothesis is that, with the high prevalence of maternal anxiety during cesarean section, ensuring painless comfortable spinal anesthesia may increase the acceptance rate of regional anesthesia during cesarean section.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| propofol spinal acceptance | Experimental | Drug: propofolThe surgeon and the anesthetist will discuss the exclusion criteria. Then they will discuss the information's about spinal and general anesthesia with the illegible patients, also reply the patient's questions in a preoperative visit. The primary decision for the patient; either spinal or general anesthesia will be recorded. The patients refusing spinal anesthesia will be discussed again to detect the rate of acceptance of spinal anesthesia if propofol sedation is ensured during the procedure to provide a painless spinal injection. The final decision will be applied; either spinal with procedural sedation, or general anesthesia. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patients scheduled for elective cesarean section,
- Age: 18 - 40 years,
- American Society of Anesthesiologists I - III,
- Patients may present any of the following conditions:
- Respiratory diseases as bronchial asthma
Key exclusion criteria (6 listed)
- Patients refusing to participate in the study,
- Known psychiatric disease,
- Addiction medications,
- Communication barrier,
- Absolute or relative contraindication for spinal 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 |
|---|---|---|
| propofolAlso: propofol procedural sedationA bolus of 0.7 mg/kg will be given initially, additional incremental doses of 20 mg propofol will be given if the patient complained of pain or moved arms towards the back. Patients will be sitting on the middle of the operating table facing towards the table's foot. The table's foot will be dropped 45 degrees for a comfortable chair position, Monitoring through pulse oximeter (SaO2), non-invasive blood pressure (NIBP) adjusted every 2 minutes automatic measuring and capnography tube in contact with nostrils. | Drug | propofol spinal acceptance |
Primary outcome
The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure.
Time frame: 30 minutes preoperative.
percent
2 secondary outcomes
The rate of initial acceptance of spinal anesthesia without sedation.
Time frame: 30 minutes preoperative.
The anxiety score.
Time frame: 30 minutes preoperative,10 minutes after spinal injection, and 30 minutes after stay at recovery room.
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 18 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol in people with Patient Compliance, run by Mansoura University at 3 sites 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 11 inclusion and 6 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure. (time frame: 30 minutes preoperative.). 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 18 Sep 2020.