An interventional study of propofol in Patient Compliance, sponsored by Mansoura University. Completed at 3 sites in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-09-18.
Sponsored by Mansoura University · Not applicable, Interventional, and Supportive care
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 10 studies in Patient Compliance with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Patient Compliance · Egypt.
Among the 10 studies in Patient Compliance with a site in Egypt, this one is one of 2 that started in 2018, is one of 5 with no phase, and was the 3rd registered.
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
Browse Patient Compliance studies →2 of the 10 studies in Patient Compliance with a site in Egypt are open now. Recruiting first, the newest first:
British University In Egypt · Sites in Egypt
Ages 19+
Assiut University · Sites in Egypt
Ages 18–65 · Healthy volunteers
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 45 Patient Compliance studies recruiting now, 25 (56%) set no upper age limit and 13 (29%) stop at 75 or younger; 11 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 40 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 228 is above the median of 116 across 527 interventional studies indexed under Patient Compliance.
Median enrollment 116 across the 6 interventional studies, 225 across the 4 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 10 have an industry lead sponsor. The 8 most frequent:
Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Mansoura University has 2 studies filed under Patient Compliance — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Patient Compliance with a site in Egypt, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: propofol
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.
Also known as: propofol procedural sedation
The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure.
percent
Time frame: 30 minutes preoperative.
The rate of initial acceptance of spinal anesthesia without sedation.
percent
Time frame: 30 minutes preoperative.
The anxiety score.
by the visual analogue score from 0-10, where 10 is the maximum anxiety level.
Time frame: 30 minutes preoperative,10 minutes after spinal injection, and 30 minutes after stay at recovery room.
The patient satisfaction regards the spinal anesthesia decision.
The patients express thier satisfaction with the spinal decision on a visual analogue score, ranging from 0 to 10, where 0 is the minimum and 10 is the maximum satisfaction level.
Time frame: 30 minutes at recovery room.
The total utilized dose of propofol.
milligram
Time frame: 1 minute after completion of spinal procedure, and 5 minutes at the end of cesarean section.
The rate of premature termination of spinal procedure (failure rate).
percent
Time frame: 20 minutes preoperative.
The sedation score.
using modified Ramsay scale, 1. Anxious, 2. Cooperative, oriented, tranquil. 3. Responsive to commands only. If Asleep. 4. Brisk response to light glabellar tap or loud auditory stimulus. 5. Sluggish response to light glabellar tap or loud auditory stimulus.
Time frame: determined 1 minutes after following spinal injection. then again after 10 minutes.
The infant Apgar score.
A measure of the physical condition of a newborn infant. Adding points (2, 1, or 0) for heart rate, respiratory effort, muscle tone, response to stimulation, and skin coloration; ranges from 0- 10, score of ten represents the best possible condition.
Time frame: 0 and 5 minutes after delivery.
Patient's choice of anesthesia next time.
spinal or general anesthesia.
Time frame: 30 minutes after shifting the patient to recovery room.
The incidence of desaturation during propofol spinal procedural sedation.
in percent, desaturation defined as oxygen saturation less than 90%
Time frame: 20 minutes preoperative.
The incidence of hypotension during propofol spinal procedural sedation.
in percent, hypotension defined as mean blood pressure less than 60 millimeter mercury.
Time frame: 20 minutes preoperative.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Jul 2018, 3 months.
Of 224 non-industry interventional studies with no phase under Patient Compliance, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's 3 months is below that.
Counting every sponsor, half of 237 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Propofol