A Phase 2 interventional study of Morphine Sulfate and Placebo in Pruritus, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-09.
Sponsored by Assiut University · Phase 2, Interventional, and Prevention
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Among 17 studies in Pruritus with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Pruritus · Egypt.
Among the 17 studies in Pruritus with a site in Egypt, this one is the 7th largest by enrollment of the 16 interventional ones that give a count, is the only one that started in 2018, is one of 5 in phase 2, and was the 2nd registered.
491 studies on the registry are indexed under Pruritus; 94 are open to participants now.
Browse Pruritus studies →2 of the 17 studies in Pruritus with a site in Egypt are open now. Recruiting first, the newest first:
Alexandria University · Sites in Egypt
Ages 18–80
Ain Shams University · Sites in Egypt
Ages 18–70
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 54 Pruritus studies recruiting now, 22 (41%) set no upper age limit and 24 (44%) stop at 75 or younger; 15 take children under 18; 10 take healthy volunteers.
This study: 20 Years to 40 Years · female · healthy volunteers too.
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17 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 80 is above the median of 60 across 423 interventional studies indexed under Pruritus.
Median enrollment 75 across the 16 interventional studies, 60 across the 1 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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None of the 17 has an industry lead sponsor. The 10 most frequent:
Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Assiut University has 3 studies filed under Pruritus — fewer than ten, so there is no comparison to draw.
1 of the studies in Pruritus with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07936292Alexandria UniversityEfficacy and Safety of Mirogabalin in Uremic Pruritus | 2027-03 |
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Among the 17 studies in Pruritus with a site in Egypt, from their registry updates:
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Neuraxial anesthesia, which includes epidural anesthesia and intrathecal anesthesia, is a frequent anesthetic approach for caesarean delivery and other lower abdominal and lower limb anesthetic procedures. The addition of neuraxial morphine to local anesthetics provides an effective and prolonged postoperative analgesia. Neuraxial administration of morphine which is considered as a gold standard for analgesia has been associated with a frequent incidence of pruritus and postoperative nausea and vomiting.
The incidence of neuraxial opioid induced pruritus varies widely from 30% - 60% after orthopedic surgery with intrathecal morphine injection and from 60% - 100% in pregnant women after neuraxial opioid administration. Parturients appear to be the most susceptible to neuraxial opioid-induced pruritus which probably might be due to the interaction of estrogens with opioid receptors.
Although the exact mechanism of neuraxial opioid induced pruritus is unclear, the postulated mechanisms include the presence of an "itch center" in the central nervous system (CNS), medullary dorsal horn activation, antagonism of inhibitory transmitters, modulation of 5-hydroxytryptamine subtype 3 (5-HT3) or serotonergic pathways and the involvement of prostaglandins.
There is dense concentration of opioid receptors and 5-HT3 receptors in the dorsal part of the spinal cord and the nucleus of the spinal tract of the trigeminal nerve in the medulla. Activation of these receptors by neuraxial opioid administration or by circulating estrogen in parturients results in neuraxial opioid induced pruritus which is usually localized to the face, neck, or upper thorax. Nalbuphine, propofol and ondansetron have been used effectively in the treatment of pruritus associated with neuraxial morphine in surgical patients.
Granisetron is a potent and highly selective 5-HT3 receptor antagonist that has little or no affinity for other 5-HT receptors, or dopaminergic, adrenergic, benzodiazepine, histaminic, or opioid receptors. Its onset of action is 1-3 min, peak plasma level 30 min, plasma half-life is 4-6 h and duration of action up to 24 h. Its longer duration of action than that of ondansetron may coincide with the peak incidence of pruritus after intrathecal morphine (6-9 h). In contrast, other 5-HT3-receptor antagonists have affinities for various receptor-binding sites. For example, ondansetron has detectable binding to 5-HT1B, 5-HT1C, α1-adrenergic, and μ-opioid receptor sites. Although not proven, the binding of these agents to additional receptor subtypes other than their target receptor may underlie the inferior adverse event profile seen with ondansetron compared with granisetron.
The study will be carried on 40 parturients scheduled for elective cesarean section (CS) under intrathecal anesthesia. They will be randomly allocated into two equal groups of 20 parturients each:
Group A: (placebo group) will receive 200 ug morphine sulphate will be injected intrathecally \& 2 mL of normal saline 0.9%.
Group B: (treatment group) will receive 200 ug morphine sulphate will be injected intrathecally \& 2 mL of 2 mg granisetron IV injection.
Preoperative assessment:
The day prior to surgery, all patients will undergo preanesthetic checkup including detailed history, thorough general, physical, systemic examination and weight of the patient. They will be kept NOP (nil per mouth) 6-8 hours for solids and 2 hours for water and clear fluids.
Preparation of the patients:
Written consent, coagulation profile, emergency resuscitation equipments including airway devices, advanced cardiac life support drugs. Parturients will be educated regarding the visual analogue scale (VAS).
Parturients in the holding area:
The patients will be positioned in the supine position, with uterine displacement to the left lateral side.
Parturient in the operating room:
The previous monitoring data will be recorded again for the second time. Then subarachnoid block will be carried out under complete aseptic condition in the sitting position with the table in the horizontal level using 25 G pencil point spinal needle. Intrathecal block will be performed at the level of L 3-4 or L 4-5 vertebral interspaces; 12.5 mg (2.5 ml) of hyperbaric bupivacaine 0.5% and 200 ug morphine sulphate will be injected intrathecally at a rate of 1 ml/15 second after obtaining free flow of CSF. Immediately after end of injection of the drugs intrathecally, the parturient will be placed in the supine position with left lateral uterine displacement by putting a wedge under right hip (15ﹾ left-tilted supine position). All patients will receive supplemental oxygen 4 L/min via facemask until delivery of the baby. Sensory block will be assessed using loss of sensation in response to cold sensation (using ice cube). Surgery will start when the maximum height of sensory block reaches T6 or higher. Motor blockade will be assessed by modified Bromage scale (1 = unable to move feet or knees; 2 = able to move feet only; 3 = just able to move knees; 4 = full flexion of knees; 5 = no detectable weakness of hip flexion while supine; 6 = able to perform partial knee bend).
A third monitoring reading of the vital data will be taken immediately, 5 min and 10 min after spinal block and before the surgical operation (CS) starts.
Intraoperative assessment:
Study outcomes:
Primary outcome:
Incidence of pruritus during the first postoperative 24 hours.
Secondary outcomes:
Duration, location of pruritus and severity of pruritus according to the pruritus grading score The pruritus grading system (PGS) score for each patient is based on: distribution, frequency, severity of itch and quality of sleep.
Pruritus Grading System
Each patient's itch grade is calculated as the sum of the individual scores as:
Mild grade: if total score is between 0 and 5.
Moderate grade: if total score is between 6 and 11.
Severe grade: if total score is between 12 and 19.
The onset of pruritus will be assessed and recorded every 15 min for 4 hours along with the complaint by the patient. Pruritus scores will then be evaluated at 4, 8 and 24 hours post-surgery. For patients with pruritus who request treatment, antihistamines such as pheniramine maleate and μ-opioid receptor antagonists such as naloxone will be used depending upon the severity assessed by the clinician, if required.
Postoperative pain assessment, by a blinded Post-Anesthesia Care Unit (PACU) nurse using VAS at 6, 12, 18 and 24 hours after intrathecal morphine injection. Visual analog scale (Fig. 1) is a validated approach to pain measurement (Wood, 2004). The most common VAS consists of a 10-cm line with one end labeled "no pain" and the other end labeled "worst pain imaginable." The patient marks the line at the point that best describes the pain intensity. The length of the line to the patient's mark is measured and recorded in millimeters. The main theoretical advantage of the VAS is that it does not limit pain to 10 discrete levels of intensity, permitting a more detailed rating of pain.
Rescue analgesia will be given in the form of perfalgan (paracetamol) 1 gm/ 6 h (max 4 gm per day) IV infusion and/or pethidine (meperidine) 1 mg/ kg IM when VAS is greater than 4.
Serum serotonin measurment:
Two blood samples (2 mL each) will be withdrawn from each parturient. One sample will be withdrawn in the holding area before preload infusion and granisetron injection (basal reading for serum serotonin) and the other one will be withdrawn 6 hours after intrathecal morphine injection in both groups. Repeated freezing and thawing of the samples should be avoided. Hemolytic and especially lipemic serum samples should not be used with this assay. Storage: up to 6 hours at 2 - 8ºC; for longer periods (up to 6 months) at - 20 ºC.
Intended use and principle of the test: Enzyme Immunoassay for the quantitative determination of serotonin in serum. In the first step, serotonin is quantitatively acylated. The subsequent competitive ELISA kit uses the microtiter plate format. The antigen is bound to the solid phase of the microtiter plate. The acylated standards, controls and samples and the solid phase bound analyte compete for a fixed number of antiserum binding sites. After the system is in equilibrium, free antigen and free antigen-antiserum complexes are removed by washing. The antibody bound to the solid phase is detected by an anti-rabbit IgG-peroxidase conjugate using TMB as a substrate. The reaction is monitored at 450 nm.
Quantification of unknown samples is achieved by comparing their absorbance with a reference curve prepared with known standard concentrations. Expected reference values in serum: Males: 80 - 450 ng/ml and females: 40 - 400 ng/ml
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
20 parturients under intrathecal anesthesia will receive 200 ug morphine sulphate intrathecally and 2 mL of normal saline 0.9% (placebo) IV injection preoperative.
Drug: Morphine Sulfate · Drug: Placebo
20 parturients under intrathecal anesthesia will receive 200 ug morphine sulphate intrathecally and 2 mL of 2 mg granisetron IV injection preoperative.
Drug: Morphine Sulfate · Drug: Granisetron
200 ug morphine sulphate will be injected intrathecally
2 mL of normal saline 0.9% IV injection
Also known as: Normal saline 0.9%
2 mL of 2 mg granisetron IV injection
Also known as: Kytril, Sancuso
Incidence of pruritus during the first postoperative 24 hours.
The effect of prophylactic intravenous (IV) administration of granisetron on incidence and severity of pruritus that occurs after intrathecal morphine in parturients undergoing cesarean section (CS).
Time frame: 24 hours
Onset time of pruritus
Recording the time when itching began
Time frame: 24 hours
The pruritus grading system (PGS)
The pruritus grading system (PGS) score (Firas et al, 2012) for each patient is based on: distribution, frequency, severity of itch and quality of sleep. Each patient's itch grade is calculated as the sum of the individual scores as: Distribution:Solitary site 1, Multiple sites 2, Generalized 3 Frequency: Episodic 1, Frequent 3, Continuous 5 Severity: Rubbing 1, Scratching 1, Localized excoriations 3, Generalized excoriations 5 Sleep disturbance: Rare 0, Occasional 2, Frequent 4,Totally restless 6 Mild grade: if total score is between 0 and 5. Moderate grade: if total score is between 6 and 11. Severe grade: if total score is between 12 and 19.
Time frame: 24 hours
Postoperative pain assessment
Postoperative pain assessment, by a blinded Post-Anesthesia Care Unit (PACU) nurse using VAS at 6, 12, 18 and 24 hours after intrathecal morphine injection. Visual analog scale is a validated approach to pain measurement (Wood, 2004). The most common VAS consists of a 10-cm line with one end labeled "no pain" and the other end labeled "worst pain imaginable." The patient marks the line at the point that best describes the pain intensity. The length of the line to the patient's mark is measured and recorded in millimeters. The main theoretical advantage of the VAS is that it does not limit pain to 10 discrete levels of intensity, permitting a more detailed rating of pain. Rescue analgesia will be given in the form of perfalgan (paracetamol) 1 gm/ 6 h (max 4 gm per day) IV infusion and/or pethidine (meperidine) 1 mg/ kg IM when VAS is greater than 4.
Time frame: 24 hours
Perioperative adverse events
Nausea, vomiting, intraoperative shortness of breath and respiratory depression (RR \< 8 breaths/ min), and postoperative headache in the first 24 hours postoperatively.
Time frame: 24 hours
Participants' satisfaction after end of the delivery
1) not satisfied or 2) satisfied and willing to take the same medication and procedure in the future when indicated.
Time frame: 24 hours
Plan to share: No
Ran from Jun 2018 to primary completion in Oct 2020, 28 months.
Of 52 phase 2 interventional studies under Pruritus, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's 28 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Granisetron