Laparoscopic OrcheopexyPhase 2NCT03156296
Transversus Abdominis Plane Block Using Dexmedetomidine and Bupivacaine
A Phase 2 study testing Dexmedetomidine and Bupivacaine in people with Laparoscopic Orcheopexy, run by Assiut University at 1 site in Egypt.
Trial summary
Pediatric laparoscopy has been first described in 1923 by Kelling but its use has increased since last decade. A laparoscopic approach offers several advantages over an open procedures; potentially reduces the surgical stress and fluid shifts that may accompany it; in addition there is less need for postoperative… Read more about this study
- Who is it for?
- Ages 3 to 8 years, men only
- Conditions the study is for
- Laparoscopic Orcheopexy
- What is being tested?
- Dexmedetomidine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2017to 31 Aug 2018
- Phase
- Phase 2
- 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 3 to 8 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II physical status patients.
- Age between 3 and 8 years.
- Children undergoing laparoscopic orcheopexy
Who cannot join
- Parent refusal
- History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
- Hypersensitivity to any local anesthetics
- Bleeding diathesis
- History of renal, hepatic, cardiac, upper or lower airway or neurological diseases
- Any sign of infection at the puncture site of the proposed block
- History of sleep apnea with which postoperative ventilation may be required
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Transversus Abdominis Plane Block Using Dexmedetomidine and Bupivacaine in Children Undergoing Laparoscopic Orcheopexy: Randomized Controlled Trial
Pediatric laparoscopy has been first described in 1923 by Kelling but its use has increased since last decade. A laparoscopic approach offers several advantages over an open procedures; potentially reduces the surgical stress and fluid shifts that may accompany it; in addition there is less need for postoperative analgesia, reduction of postoperative respiratory and wound complications; shortens postoperative convalescence, including an intensive care unit stay; rapid return to normal diet and decreased overall hospital stay.
Despite the minimally invasive nature, pain can be moderate to severe in the immediate postoperative period.
Read more
Inadequate control of post-operative pain leads to several unwanted adverse events ranging from patients' discomfort and prolonged immobilization to thromboembolic phenomenon and pulmonary complications.
Analgesic multimodalities were recommended to relieve the post-operative pain. Opioids although provide satisfactory analgesia, they are associated with unwanted side-effects.
Transversus abdominis plane (TAP) block is a type of peripheral nerve block that involves innervations of the anterolateral abdominal wall. It provides adequate post-operative pain relieve following various abdominal surgeries.
With the aid of ultrasound or anatomical landmark guidance, local anesthetic (LA) is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located.
Ultrasound TAP block is also accompanied by a good pain relief and reduced intraoperative and postoperative opioids requirements after laparoscopic surgery. In this case a bilateral TAP block is necessary because the abdominal skin incisions for the ports of laparoscopic procedure are performed on both sides.
Unfortunately, TAP block duration is limited to the effect of administered LA. Recently, adjuvant medications were added to LA to prolong the effect of TAP block. Dexmedetomidine is a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Its use with bupivacaine either epidurally or intrathecally is associated with prolongation of the LA effect.
Read the detailed description
Preoperative assessment:
The day prior to surgery, all patients will undergo pre-anesthetic checkup including detailed history, thorough general, physical, systemic examination and weight of the patient. All children will be kept nil per mouth for 8 h for solids and 2 h for clear liquids.
Preparation of the patient:
- Written consent, coagulation profile, emergency resuscitation equipments including airway devices, pediatric advanced life support drugs for LA toxicity will be available.
- All patients will be premedicated with oral midazolam of 0.5 mg/kg about 20 minutes before induction of anesthesia.
Intraoperative management:
Intraoperative monitoring will include ECG, pulse oximetry, noninvasive blood pressure, capnography and temperature probe.
All patients in this study will be anesthetized by the same team of anesthesiologists and operated upon by the same surgeon who will be unaware of the study medications.
General anesthesia will be standardized for all patients in both groups using 8 MAC sevoflurane in 100% O2 with appropriate size face mask. After intravenous access securing, atropine 0.02 mg/kg and fluid bolus of 20 ml/kg will be given to offset hemodynamic effects when pneumoperitoneum is created. Endotracheal intubation with appropriate size to the patient's age will be performed after administration of 2 mg/kg propofol and 0.5 mg/kg of atracurium. After tracheal intubation, the stomach is suctioned with an orogastric tube and bladder catheterization is done in order to decrease the risk of visceral injury during trocar insertion. Controlled mechanical ventilation will be used to maintain end-tidal carbon dioxide at 35±5 mmHg. Minute ventilation will need to be increased by 20% or more to maintain normocapnia. General anesthesia will be maintained with 2-3 MAC sevoflurane delivered in 100% O2.
Patients will be placed in the supine position and TAP block will be performed under ultrasound guidance. After skin preparation, the linear ultrasound probe (high frequency probe 7-12 MHz) connected to a portable ultrasound unit( MANDRAY ) will be placed in the axial plane across the mid-axillary line midway between the costal margin and the highest point of iliac crest. A 22 G × 50 mm PAJUNK needle attached with tubing system to a syringe filled with the LA solution will be inserted in plane with the ultrasound probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles. After careful aspiration to exclude vascular puncture, injection of the study medication will be performed leading to separation between the internal oblique and the transversus abdominis muscles which will appear as a hypoechoic space on ultrasound. This procedure will be repeated on the opposite side of the midline.
MAP, HR, SpO2 and ETCO2 will be recorded before induction of anesthesia, before block, after the block and every 10 minutes till end of surgery. Skin incision will be made 15-20 min after TAP block (Rozen et al, 2008). An increase in HR and MAP above 20% of baseline values with skin incision will be considered signs of inadequate analgesia. In these cases, fentanyl 1 μg/kg will be given intravenously, and the case will be excluded from the study.
The table position itself may need to be changed repeatedly during the operation; both the trendelenburg and the reverse trendelenburg positions are often used. Children may be placed near the foot end of the table. Accordingly, care must be taken to secure the patient to the table (e.g., using rolls of gauze and tape). Well padding of extremities should be ensured.
Restriction of the intraabdominal pressure to 6-12 mmHg in children will be recommended. These pressures have minimal effects on cardiac index. Intraoperative hypotension defined as fall in MAP by 20% from the baseline requiring a fluid bolus and bradycardia defined as a decrease in HR by 20% from the baseline value requiring atropine will be recorded. Perioperative blood loss will be replaced using crystalloids and blood as indicated.
After completion of the surgical procedure, reversal of neuromuscular blockade effect and extubation will be done after ensuring adequate orogastric suction and empting of pneumoperitonem. Bilateral air entry should be checked at the end of anesthesia. Patients will be transferred to the postanesthesia care unit (PACU).
In PACU: MAP, HR, modified CHEOPS and nausea \& vomiting score will be recorded on admission to PACU, 1, 4, 8, 12, 18, 24 h postoperatively by an observer who will be unaware of the study protocol.
Postoperative pain will be measured using a modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS).
Patients with modified CHEOPS > 6 will be given rescue analgesia with 15 mg/kg paracetamol intravenously. Those with modified CHEOPS of 4-5 will be given paracetamol 15 mg/kg as suppository. Pain scores will be recorded every 10 minutes after administration of rescue analgesia to evaluate pain relief or need for further rescue analgesia. The number of children who will need postoperative rescue analgesics and the duration of analgesia that will be taken at the time when an analgesic is required will be recorded.
Patients will be discharged from the hospital when they are pain free and there is no other medical reason to admit them to a surgical ward. The parents who will be involved in the clinical trial will be invited to complete a postoperative chart with a simple pain scale (0 = no pain/child calm; 1 = minimum pain/child irritable; 2 = mild pain/child consolable; and 3 = severe pain/child inconsolable). Parents will be instructed to give their children oral ibuprofen 10 mg/kg when pain scores 2 or 3, and not more frequently than every 8 hours.
Postoperative vomiting episodes will be recorded and treated with intravenous Metoclopramide 0.5 mg/kg. Postoperative sedation will be assessed using sedation score described by Culebras et al, 2001 (1. Awake and alert. 2. Sleeping but easily arouses to voice or light touch. 3. Arouses to loud voice or shaking. 4. Arouses with painful stimuli only. 5. Unrousable).
Other postoperative complications as infection or hematoma formation will be recorded.
The parents will be asked to evaluate their satisfaction regarding pain control at the end of 24 h postoperatively through 5-point Likert scale (1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very dissatisfied).
- Conditions
- Laparoscopic Orcheopexy
- Being tested
- Dexmedetomidine, Bupivacaine
- Keywords
- transversus abdominis plane block , Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
patients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 0.25 mg/kg dexmedetomidine dissolved in 2 ml normal saline (0.9%)
BupivacaineDrug
patients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 2 ml normal saline (0.9%)
| Study group | Role | What they receive |
|---|---|---|
| BUPIVACAINE | Active comparator | patients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 2 ml normal saline (0.9%) Receives: Drug: Bupivacaine |
| DEXMEDETOMIDINE | Active comparator | patients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 0.25 mg/kg dexmedetomidine dissolved in 2 ml normal saline (0.9%) Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHEOPS
postoperative pain assessment score in children
Measured: 24 hours
Secondary outcomes (2)
Time to first analgesia
Time of intravenous paracetamol requirement postoperatively
Measured: 24 hours
5-point Likert scale
parent satisfaction score
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start10 Jun 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic OrcheopexyStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAGAA AHMED HERDAN, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156296
- Sponsor's protocol ID
- ultrasound guided TAP block
- Status last verified
- Sep 2018
- First submitted
- 11 May 2017
- Last updated
- 24 Sep 2018
- 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 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Transversus Abdominis Plane Block Using Dexmedetomidine and Bupivacaine in Children Undergoing Laparoscopic Orcheopexy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03156296
- Acronym / sponsor ID
- ultrasound guided TAP block
- Conditions
- Laparoscopic Orcheopexy
- Keywords
- transversus abdominis plane block , Dexmedetomidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 17 May 2017 (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.
Pediatric laparoscopy has been first described in 1923 by Kelling but its use has increased since last decade. A laparoscopic approach offers several advantages over an open procedures; potentially reduces the surgical stress and fluid shifts that may accompany it; in addition there is less need for postoperative analgesia, reduction of postoperative respiratory and wound complications; shortens postoperative convalescence, including an intensive care unit stay; rapid return to normal diet and decreased overall hospital stay.
Despite the minimally invasive nature, pain can be moderate to severe in the immediate postoperative period.
Inadequate control of post-operative pain leads to several unwanted adverse events ranging from patients' discomfort and prolonged immobilization to thromboembolic phenomenon and pulmonary complications.
Analgesic multimodalities were recommended to relieve the post-operative pain. Opioids although provide satisfactory analgesia, they are associated with unwanted side-effects.
Transversus abdominis plane (TAP) block is a type of peripheral nerve block that involves innervations of the anterolateral abdominal wall. It provides adequate post-operative pain relieve following various abdominal surgeries.
With the aid of ultrasound or anatomical landmark guidance, local anesthetic (LA) is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located.
Ultrasound TAP block is also accompanied by a good pain relief and reduced intraoperative and postoperative opioids requirements after laparoscopic surgery. In this case a bilateral TAP block is necessary because the abdominal skin incisions for the ports of laparoscopic procedure are performed on both sides.
Unfortunately, TAP block duration is limited to the effect of administered LA. Recently, adjuvant medications were added to LA to prolong the effect of TAP block. Dexmedetomidine is a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Its use with bupivacaine either epidurally or intrathecally is associated with prolongation of the LA effect.
Detailed description
Preoperative assessment:
The day prior to surgery, all patients will undergo pre-anesthetic checkup including detailed history, thorough general, physical, systemic examination and weight of the patient. All children will be kept nil per mouth for 8 h for solids and 2 h for clear liquids.
Preparation of the patient:
- Written consent, coagulation profile, emergency resuscitation equipments including airway devices, pediatric advanced life support drugs for LA toxicity will be available.
- All patients will be premedicated with oral midazolam of 0.5 mg/kg about 20 minutes before induction of anesthesia.
Intraoperative management:
Intraoperative monitoring will include ECG, pulse oximetry, noninvasive blood pressure, capnography and temperature probe.
All patients in this study will be anesthetized by the same team of anesthesiologists and operated upon by the same surgeon who will be unaware of the study medications.
General anesthesia will be standardized for all patients in both groups using 8 MAC sevoflurane in 100% O2 with appropriate size face mask. After intravenous access securing, atropine 0.02 mg/kg and fluid bolus of 20 ml/kg will be given to offset hemodynamic effects when pneumoperitoneum is created. Endotracheal intubation with appropriate size to the patient's age will be performed after administration of 2 mg/kg propofol and 0.5 mg/kg of atracurium. After tracheal intubation, the stomach is suctioned with an orogastric tube and bladder catheterization is done in order to decrease the risk of visceral injury during trocar insertion. Controlled mechanical ventilation will be used to maintain end-tidal carbon dioxide at 35±5 mmHg. Minute ventilation will need to be increased by 20% or more to maintain normocapnia. General anesthesia will be maintained with 2-3 MAC sevoflurane delivered in 100% O2.
Patients will be placed in the supine position and TAP block will be performed under ultrasound guidance. After skin preparation, the linear ultrasound probe (high frequency probe 7-12 MHz) connected to a portable ultrasound unit( MANDRAY ) will be placed in the axial plane across the mid-axillary line midway between the costal margin and the highest point of iliac crest. A 22 G × 50 mm PAJUNK needle attached with tubing system to a syringe filled with the LA solution will be inserted in plane with the ultrasound probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles. After careful aspiration to exclude vascular puncture, injection of the study medication will be performed leading to separation between the internal oblique and the transversus abdominis muscles which will appear as a hypoechoic space on ultrasound. This procedure will be repeated on the opposite side of the midline.
MAP, HR, SpO2 and ETCO2 will be recorded before induction of anesthesia, before block, after the block and every 10 minutes till end of surgery. Skin incision will be made 15-20 min after TAP block (Rozen et al, 2008). An increase in HR and MAP above 20% of baseline values with skin incision will be considered signs of inadequate analgesia. In these cases, fentanyl 1 μg/kg will be given intravenously, and the case will be excluded from the study.
The table position itself may need to be changed repeatedly during the operation; both the trendelenburg and the reverse trendelenburg positions are often used. Children may be placed near the foot end of the table. Accordingly, care must be taken to secure the patient to the table (e.g., using rolls of gauze and tape). Well padding of extremities should be ensured.
Restriction of the intraabdominal pressure to 6-12 mmHg in children will be recommended. These pressures have minimal effects on cardiac index. Intraoperative hypotension defined as fall in MAP by 20% from the baseline requiring a fluid bolus and bradycardia defined as a decrease in HR by 20% from the baseline value requiring atropine will be recorded. Perioperative blood loss will be replaced using crystalloids and blood as indicated.
After completion of the surgical procedure, reversal of neuromuscular blockade effect and extubation will be done after ensuring adequate orogastric suction and empting of pneumoperitonem. Bilateral air entry should be checked at the end of anesthesia. Patients will be transferred to the postanesthesia care unit (PACU).
In PACU: MAP, HR, modified CHEOPS and nausea \& vomiting score will be recorded on admission to PACU, 1, 4, 8, 12, 18, 24 h postoperatively by an observer who will be unaware of the study protocol.
Postoperative pain will be measured using a modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS).
Patients with modified CHEOPS > 6 will be given rescue analgesia with 15 mg/kg paracetamol intravenously. Those with modified CHEOPS of 4-5 will be given paracetamol 15 mg/kg as suppository. Pain scores will be recorded every 10 minutes after administration of rescue analgesia to evaluate pain relief or need for further rescue analgesia. The number of children who will need postoperative rescue analgesics and the duration of analgesia that will be taken at the time when an analgesic is required will be recorded.
Patients will be discharged from the hospital when they are pain free and there is no other medical reason to admit them to a surgical ward. The parents who will be involved in the clinical trial will be invited to complete a postoperative chart with a simple pain scale (0 = no pain/child calm; 1 = minimum pain/child irritable; 2 = mild pain/child consolable; and 3 = severe pain/child inconsolable). Parents will be instructed to give their children oral ibuprofen 10 mg/kg when pain scores 2 or 3, and not more frequently than every 8 hours.
Postoperative vomiting episodes will be recorded and treated with intravenous Metoclopramide 0.5 mg/kg. Postoperative sedation will be assessed using sedation score described by Culebras et al, 2001 (1. Awake and alert. 2. Sleeping but easily arouses to voice or light touch. 3. Arouses to loud voice or shaking. 4. Arouses with painful stimuli only. 5. Unrousable).
Other postoperative complications as infection or hematoma formation will be recorded.
The parents will be asked to evaluate their satisfaction regarding pain control at the end of 24 h postoperatively through 5-point Likert scale (1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very dissatisfied).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BUPIVACAINE | Active comparator | Drug: Bupivacainepatients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 2 ml normal saline (0.9%) |
| DEXMEDETOMIDINE | Active comparator | Drug: Dexmedetomidinepatients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 0.25 mg/kg dexmedetomidine dissolved in 2 ml normal saline (0.9%) |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I-II physical status patients.
- Age between 3 and 8 years.
- Children undergoing laparoscopic orcheopexy
Key exclusion criteria (7 listed)
- Parent refusal
- History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
- Hypersensitivity to any local anesthetics
- Bleeding diathesis
- History of renal, hepatic, cardiac, upper or lower airway or neurological diseases
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 |
|---|---|---|
| Dexmedetomidinepatients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 0.25 mg/kg dexmedetomidine dissolved in 2 ml normal saline (0.9%) | Drug | DEXMEDETOMIDINE |
| Bupivacainepatients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 2 ml normal saline (0.9%) | Drug | BUPIVACAINE |
Primary outcome
CHEOPS
Time frame: 24 hours
postoperative pain assessment score in children
2 secondary outcomes
Time to first analgesia
Time frame: 24 hours
5-point Likert scale
Time frame: 24 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 24 Sep 2018.
- 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 Phase 2 study testing Dexmedetomidine and Bupivacaine in people with Laparoscopic Orcheopexy, run by Assiut 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 3 inclusion and 7 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 24 Sep 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
CHEOPS (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 24 Sep 2018.